US20080228032A1 - Cardiac visualization devices and methods - Google Patents

Abstract

Devices and methods for facilitating transvascular, minimally invasive and other “less invasive” surgical procedures generally include a sheath with an expandable balloon at the distal end, an inflation lumen for expanding the balloon, and a device passage lumen for allowing passage of one or more surgical instruments. The sheath is configured to house at least one visualization device such that an optical element of the device is positioned to view the surgical site. In some embodiments, instruments may be passed through the sheath, with the distal balloon partially or fully circumscribing or encircling the instruments. Any suitable instrument(s) may be passed through sheaths of the invention, such as a surgical clip applier for repairing a heart valve, an ablation member for treating atrial fibrillation, one or more pacemaker leads, a coronary sinus access device or the like.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of U.S. Application 60/500,733 filed on Sep. 3, 2003 (Attorney Docket (GDS 1010-1).
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates generally to medical devices and methods. More particularly, the invention relates to visualization devices and methods for facilitating cardiac surgical procedures, such as repair of the mitral or tricuspid valve for treating mitral or tricuspid regurgitation.
• In recent years, many advances have been made to reduce the invasiveness of cardiac surgery. In an attempt to avoid open, stopped-heart procedures, which may be accompanied by high patient morbidity and mortality, many devices and methods have been developed for operating on a heart through smaller incisions, operating on a beating heart, and even performing cardiac procedures via transvascular access. Different types of cardiac procedures, such as cardiac ablation techniques for treating atrial fibrillation, stenting procedures for atherosclerosis, and valve repair procedures for treating conditions such as mitral regurgitation have experienced significant technological advances. In implementing many, if not all, transvascular, minimally invasive and other cardiac surgery techniques, visualization of the heart, the surgical field, surrounding structures, and the like is essential. At the same time, visualization is often difficult, due to the rapid movement of a beating heart as well as the large quantities of pumping blood in an intracardiac surgical field.
• One type of cardiac surgery which may benefit from less invasive techniques is heart valve repair. Traditional treatment of heart valve stenosis or regurgitation, such as mitral or tricuspid regurgitation, typically involves an open-heart surgical procedure to replace or repair the valve. Valve repair procedures typically involve annuloplasty, a set of techniques designed to restore the valve annulus shape and strengthen the annulus. Conventional annuloplasty surgery generally requires a large incision into the thorax of the patient (a thoracotomy), and sometimes a median sternotomy (cutting through the middle of the sternum). These open heart, open chest procedures routinely involve placing the patient on a cardiopulmonary bypass machine for sustained periods so that the patient's heart and lungs can be artificially stopped during the procedure. Finally, valve repair and replacement procedures are typically technically challenging and require a relatively large incision through the wall of the heart to access the valve.
• Due to the highly invasive nature of open heart valve repair or replacement, many patients, such as elderly patients, patients having recently undergone other surgical procedures, patients with comorbid medical conditions, children, late-stage heart failure patients, and the like, are often considered too high-risk to undergo heart valve surgery and are relegated to progressive deterioration and cardiac enlargement. Often, such patients have no feasible alternative treatments for their heart valve conditions.
• To obviate this situation, a number of devices and methods for repairing a mitral valve to treat mitral regurgitation in a less invasive manner have been developed. Some devices provide for heart valve repair through minimally invasive incisions or intravascularly, while others improve upon open heart surgical procedures on beating hearts, stopped hearts or both. For example, several improved devices and methods for heart valve repair are described in one or more patent applications filed by the inventors of the present invention and assigned to the assignee of the present invention. For further description of such devices and methods, reference may be made to U.S. patent application Ser. No. 10/461043 (Attorney Docket No. 16886-000310), filed on Jun. 13, 2003, which is hereby incorporated fully by reference.
• As mentioned above, one of the main challenges in performing minimally invasive surgery on a heart, heart valve, or any other structure is obtaining adequate visualization of the structure and the surgical field. Visualizing a cardiac valve annulus in a beating heart procedure is especially challenging due to rapid movement of the annulus and the heart, the small size of the annulus, and the blood-filled surgical field. Current visualization of minimally invasive cardiac procedures is typically accomplished via transesophageal echocardiogram (TEE). Although this technique works relatively well for some cardiac procedures, it does not provide as clear a picture of the surgical site as would direct visualization. Thus, TEE may not be sufficient for visualizing a minimally invasive procedure within the heart, especially a beating heart procedure to repair a valve annulus.
• To obtain direct visualization within the heart, any suitable endoscopic device may be introduced into the heart, such as a conventional endoscope or ultrasonic probe. One problem encountered with such devices, however, is that their ability to provide visualization is often severely reduced by the presence of blood in the heart that surrounds the optic element of the visualization device. A number of devices have been described to combat this problem. For example, U.S. Pat. No. 6,346,074, issued to Roth on Feb. 12, 2002, describes an endoscope having a distal balloon over its end. Such devices still have certain shortcomings, however. For example, balloon-covered endoscope devices are typically introduced into the surgical site through a sheath or introducer device separately from any of the instruments used to perform the cardiac procedure. Thus, the visualization device must typically be manipulated apart from the surgical instruments, and the optical element of the device may often be positioned significantly apart from the working ends of the instruments and the surgical site. In other balloon endoscope devices, the endoscope must be advanced to the surgical site to visualize the site and then removed to allow a surgical instrument to be advanced through the same sheath to perform the procedure. Obviously, such a technique may require numerous, awkward switch-outs of endoscope and surgical instrument and will not result in direct, real-time visualization of the procedure.
• Many minimally invasive or “less invasive” surgical procedures other than heart valve repair would also benefit from improved visualization. For example, improved visualization could facilitate other cardiac procedures, such as accessing the coronary sinus for placement of an implantable device or for performing a procedure, placing pacemaker leads in one or more areas of the heart, ablation procedures such as ablation around the pulmonary veins to treat atrial fibrillation, atrial-septal defect repair procedures, and the like. Improved visualization could also be used to enhance non-cardiac procedures such cinching or otherwise treating a bladder, stomach, gastroesophageal junction, vascular structure, gall bladder or the like.
• Therefore, it would be beneficial to have improved visualization devices and methods for use in transvascular, minimally invasive and other “less invasive” surgical procedures, such as heart valve repair and other cardiac procedures. Devices and methods for providing such visualization would ideally be minimally invasive and would enhance a physician's ability to locate, visualize and repair a valve annulus, atrial-septal defect, or other cardiac structure accurately and efficiently. Ideally, visualization of the surgical site would be as direct as possible, with an optic element of the visualization device being positioned close to the site. Also ideally, the visualization device would provide visualization at the same time that the physician was performing the procedure and further provide or facilitate access for surgical and/or diagnostic instruments to operate in the visualized field. At least some of these objectives will be met by the present invention.
• 2. Description of the Background Art
• U.S. Pat. No. 6,346,074 describes an endoscope having a balloon over its distal end for use in intracardiac surgery. Patent publications related to mitral valve repair include WO01/26586; US2002/0163784A12; US2002/0156526; US2002/0042621; 2002/0087169; US2001/0005787; US2001/0014800; US2002/0013621; US2002/0029080; US2002/0035361; US2002/0042621; US2002/0095167; and US2003/0074012. U.S. patents related to mitral valve repair include U.S. Pat. Nos. 4,014,492; 4,042,979; 4,043,504; 4,055,861; 4,700,250; 5,366,479; 5,450,860; 5,571,215; 5,674,279; 5,709,695; 5,752,518; 5,848,969; 5,860,992; 5,904,651; 5,961,539; 5,972,004; 6,165,183; 6,197,017; 6,250,308; 6,260,552; 6,283,993; 6,269,819; 6,312,447; 6,332,893; and 6,524,338. Publications of interest include De Simone et al. (1993)Am. J. Cardiol.73:721-722 and Downing et al. (2001)Heart Surgery Forum,Abstract 7025.
BRIEF SUMMARY OF THE INVENTION
• Devices and methods of the present invention facilitate transvascular, minimally invasive and other “less invasive” surgical procedures, such as heart valve repair procedures, by providing direct visualization of a surgical site. “Less invasive,” for the purposes of this application, means any procedure that is less invasive than traditional, large-incision open surgical procedures. Thus, a less invasive procedure may be an open surgical procedure involving one or more smaller incisions, a transvascular percutaneous procedure, a transvascular procedure via out-down, a laparoscopic procedure, or the like. Generally, any procedure in which a goal is to minimize or reduce invasiveness to the patient may be considered less invasive. Furthermore, although the terms “less invasive” and “minimally invasive” may sometimes be used interchangeably in this application, neither these nor other descriptive terms should be interpreted to limit the scope of the invention. Generally, visualization devices and methods of the invention may be used in performing or enhancing any suitable procedure.
• In addition to facilitating visualization, devices and methods of the invention also facilitate access for positioning one or more instruments to the surgical site for performing a procedure. The devices generally include a sheath with an expandable balloon at the distal end, an inflation lumen for expanding the balloon, and a device passage lumen for allowing passage of one or more surgical instruments. The sheath is configured to house at least one visualization device such that an optical element of the device is positioned to view the surgical site. In some embodiments, instruments may be passed through the sheath, with the distal balloon partially or fully circumscribing or encircling the instruments. In other embodiments, the balloon may be adjacent, but not encircling, a lumen for instrument passage. Any suitable instrument(s) may be passed through sheaths of the invention, such as a surgical clip applier for repairing a heart valve, an ablation member for treating atrial fibrillation, a suturing device, and/or the like. By positioning a lumen for passage of instruments adjacent a balloon-covered visualization device, sheaths of the present invention provide improved, direct visualization of a surgical site for performing a procedure.
• As mentioned above, the present application often focuses on visualization devices and methods as used in heart valve repair, and more specifically mitral valve repair to treat mitral regurgitation. It should be emphasized, however, that visualization devices and methods of the invention may be used in any suitable procedure, both cardiac and non-cardiac. For example, they may be used in procedures to repair the aortic or pulmonary valve, to repair an atrial-septal defect, to access and possibly perform a procedure from the coronary sinus, to place one or more pacemaker leads, to perform a cardiac ablation procedure, and/or the like. In other embodiments, the devices and methods may be used to enhance a laparoscopic or other endoscopic procedure on any part of the body, such as the bladder, stomach, gastroesophageal junction, vasculature, gall bladder, or the like. Therefore, although the following description typically focuses on mitral valve and other heart valve repair, such description should not be interpreted to limit the scope of the invention as defined by the claims.
• That being said, in one aspect of the invention, a method for performing a procedure on a heart involves first advancing an elongate sheath to a location in the heart for performing the procedure. Next, an expandable balloon coupled with a distal end of the elongate sheath is inflated and the location in the heart is visualized through the expandable balloon, using at least one visualization device disposed in the elongate sheath. Finally, at least part of the procedure is performed using one or more instruments extending through a first lumen of the elongate sheath.
• In some embodiments, the elongate sheath may be flexible so that it may be advanced through the vasculature of a patient to position at least a distal portion of the sheath in the heart. For example, the sheath may be advanced through the internal jugular vein, superior vena cava, right atrium and interatrial septum of the patient to position the distal portion of the sheath in the left atrium. Alternatively, the sheath may be advanced through the internal jugular vein, superior vena cava, right atrium, coronary sinus and left atrial wall of the patient to position the distal portion of the sheath in the left atrium. In still another embodiment, a flexible sheath may be advanced through the femoral vein, inferior vena cava, right atrium and interatrial septum. In other embodiments, the sheath may be rigid and may be introduced via thorascopically or otherwise through the heart wall.
• Inflating the balloon typically involves injecting a fluid into the balloon via a second lumen in the sheath, though any other inflation method may be used. The balloon may have any shape, such as a toroidal balloon encircling the first lumen or a spherical or ovoid balloon adjacent the first lumen. Optionally, methods may further include passing at least one fluid through the first lumen to flush the location for performing the procedure and/or to cleanse one or more instruments positioned in the first lumen. Also optionally, a method may include retracting an outer tubular member to expose additional expandable balloon material from the distal end of the sheath and further inflating the expandable balloon.
• The visualizing step may be performed using any suitable visualization device in any location. For example, a fiberoptic viewing scope, typically in combination with a fiberoptic or other illuminator may be used. Another embodiment may employ a charge coupled device with illumination, essentially a small camera, for visualization. In some embodiments, the visualization device is disposed within the elongate sheath for visualizing the surgical site. Sometimes, the visualization device is disposed in a second lumen of the sheath, the second lumen comprising an inflation lumen for inflating the expandable balloon. In some embodiments, a separate visualization device may be passed into the sheath through the second lumen to position the visualization device for visualizing the location. In some embodiments, the visualization device is disposed between an outer tubular member and an inner tubular member of the sheath. The annular space between the two tubular members may also act as an inflation lumen.
• Optionally, the method may include visualizing a first view of the location with the visualization device in a first position in the sheath, moving the visualization device to at least a second position in the sheath, and visualizing a second view of the location with the visualization device in the second position. Thus, two or more different views of a surgical site may be acquired using the sheath device and one visualization device; Alternatively, visualization of multiple views may be accomplished via a plurality of visualization devices disposed at various positions in the sheath, for example, disposed at different circumferential positions surrounding a central device passage lumen. In these and other embodiments, a central processing unit may be used to process captured images of the surgical site. Such processed images may then be transmitted proximally for viewing by the physician. For example, in one embodiment visualization may be achieved using a light source and one or more sensors or detectors disposed in a 360-degree array around an inner, device-passage lumen, the light source and the detectors disposed at the distal end of a visualization device. The sensors may then be coupled with a charge coupled device (CCD) disposed near the distal end of the device, the CCD being coupled with a wire that transmits data proximally along the visualization device.
• Any suitable surgical procedure may be performed using the devices and methods of the invention. Typically, the procedures will be transvascular, minimally invasive, or other “less invasive” procedures, as discussed above. In some embodiments, the procedure involves repairing a heart valve, such as a mitral, tricuspid, aortic or pulmonary valve. For example, repairing the valve may involve applying clips to a valve annulus using a clip applier extending through the first lumen of the sheath. Such a procedure may further include cinching a tether coupled with the applied clips to decrease a diameter of the valve annulus. In some embodiments, the procedure may be further enhanced by passing a fluid, such as saline, through the first lumen in a direction from a proximal end of the sheath toward the distal end of the sheath to cleanse the surgical instrument(s), clear an area around the surgical site, and/or cleanse the external surface of the balloon.
• In another aspect, a device for facilitating a procedure on a heart includes an elongate sheath having a proximal end, a distal end, a first lumen extending from the proximal end to the distal end, and at least a second lumen, and an expandable balloon coupled with the elongate sheath at or near the distal end, wherein the balloon at least partially encircles the first lumen, and the second lumen opens into the balloon for inflating the balloon. The elongate sheath may include one or more rigid tubular members and/or one or more flexible tubular members. In some embodiments, for example, the sheath includes an inner tubular member having an inner surface defining the first lumen and an outer tubular member disposed over the inner tubular member. In such embodiments, the annular space between the inner tubular member and the outer tubular member may form the second lumen.
• The expandable balloon may be coupled with the inner tubular member and the outer tubular member at or near the distal end of the sheath such that the second lumen acts as an inflation lumen. Such a balloon may be toroidal in shape, for example, with the first lumen being continuous with a central aperture in the toroidal balloon. Optionally, the outer member may be slidable proximally to expose additional material of the expandable balloon to allow the balloon to further expand. In an alternative embodiment, an slidable outer sleeve may be disposed over the outer tubular member to provide for additional exposure and expansion of an expandable balloon.
• The sheath may also include at least one visualization device disposed within the second lumen. For example, the visualization device may include one or more fiber optic devices, ultrasound transducers, charge coupled devices, cameras, light sources and/or sensors. In some embodiments, the distal end of the visualization device is disposed within the expandable balloon. Also in some embodiments, the visualization device is movable within the sheath. For example, where the sheath comprises an inner tubular member and an outer tubular member and the second lumen comprises an annular space between the inner and outer tubular members, the visualization member may be movable around the circumference of the second lumen. In alternative embodiments, the sheath may not include a visualization device but may have a lumen, such as the second lumen, that is sufficiently large to allow passage of at least one visualization device to position a distal end of the device within the expandable balloon.
• In some embodiments, the inner diameter of the first lumen is sufficiently large to allow passage of at least one instrument for performing the procedure on the heart. A variety of surgical instruments may thus be passed, though they will often be catheter-based, transvascular, or other less invasive instruments. In one embodiment, the instrument is clip applier for applying a plurality of tethered clips to a valve annulus of the heart and cinching a tether coupled with the clips to reduce a diameter of the valve. In another embodiment, the instrument may be an ablation member for ablating a portion of the heart, such as in a procedure to treat atrial fibrillation.
• In another aspect of the invention, a device for facilitating a procedure on a heart includes an elongate sheath having a proximal end, a distal end, a first lumen extending from the proximal end to the distal end, and at least a second lumen, and an expandable balloon coupled with the elongate sheath at or near the distal end and adjacent the first lumen, wherein the second lumen opens into the balloon for inflating the balloon. Unlike the embodiment just described, here the surgical instrument(s) may pass adjacent to but not through the balloon. Typically, in such embodiments, the balloon will have a spherical, ovoid or other suitable shape, but will not be toroidal or “donut-shaped” as in the embodiments described above. These and other embodiments are described more fully below, with reference to the appended drawing figures.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a frontal, cross-sectional view of a human heart with a visualization device positioned for performing an intracardiac procedure, in accordance with one embodiment of the present invention;
• FIG. 2 is a perspective view of a visualization device for performing a minimally invasive cardiac procedure, in accordance with one embodiment of the present invention;
• FIG. 3 is a side, cross-sectional view of the visualization device inFIG. 2; and
• FIG. 4 is a perspective view of a visualization device for performing a minimally invasive cardiac procedure, in accordance with another embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
• Devices and methods for facilitating transvascular, minimally invasive and other “less invasive” surgical procedures generally include a sheath with an expandable balloon at the distal end, an inflation lumen for expanding the balloon, and a device passage lumen for allowing passage of one or more surgical instruments. The sheath is configured to house at least one visualization device such that an optical element of the device is positioned to view the surgical site. In some embodiments, instruments may be passed through the sheath, with the distal balloon partially or fully circumscribing or encircling the instruments. In other embodiments, the balloon may be adjacent, but not encircling, a lumen for instrument passage. Any suitable instrument(s) may be passed through sheaths of the invention, such as a surgical clip applier for repairing a heart valve, an ablation member for treating atrial fibrillation, a suturing device, and/or the like. By positioning a lumen for passage of instruments adjacent a balloon-covered visualization device, sheaths of the present invention provide improved, direct visualization of a surgical site for performing a procedure.
• As discussed above, the present application often focuses on visualization devices and methods as used in heart valve repair, and more specifically mitral valve repair to treat mitral regurgitation. It should be emphasized, however, that visualization devices and methods of the invention may be used in any suitable procedure, both cardiac and non-cardiac. For example, they may be used in procedures to repair the aortic or pulmonary valve, to repair an atrial-septal defect, to access and possibly perform a procedure from the coronary sinus, to place one or more pacemaker leads, to perform a cardiac ablation procedure, and/or the like. In other embodiments, the devices and methods may be used to enhance a laparoscopic or other endoscopic procedure on any part of the body, such as the bladder, stomach, gastroesophageal junction, vasculature, gall bladder, or the like. Therefore, although the following description typically focuses on mitral valve and other heart valve repair, such description should not be interpreted to limit the scope of the invention as defined by the claims.
• That being said, and referring now toFIG. 1, anexemplary sheath10 of the present invention suitably comprises an elongatetubular member11 having a distal end and a proximal end. Anexpandable balloon12 is typically coupled withsheath10 at or near the distal end, and one ormore treatment devices14 may be passed through an aperture in the distal end. One or more visualization devices (not shown) may be coupled with or inserted intosheath10 such that an optical element of the visualization device(s) extends up to or withinballoon12.
• Generally,sheath10 may be flexible, rigid, or part-flexible part-rigid, and may be introduced to a surgical site via any suitable method or route. InFIG. 1, for example,sheath10 has been advanced to the mitral valve MV of a heart H through the superior vena cava SVC, right atrium RA, foramen ovale FO, and left atrium LA. Access to the superior vena cava SVC may be gained, for example, via the internal jugular vein. In other embodiments, access to the RA may be gained through the femoral vein and the inferior vena cava. Thus, access to the heart H may be achieved via a transvascular route. Alternatively,sheath10 may be introduced through an incision and/or access port in the wall of the left atrium LA. Such access is discussed more fully in U.S. patent application Ser. No. 10/461043 (Attorney Docket No. 16886-000310), previously incorporated by reference. Any other suitable minimally invasive means for gaining access may alternatively be used to positionsheath10 in a desired location for visualizing and performing a procedure.
• Referring now toFIGS. 2 and 3, one embodiment ofsheath10 suitably includes anouter tubular member11 and aninner tubular member13, with the annular space between the two tubular members comprising aninflation lumen22 and the space withininner tubular member13 comprising adevice passage lumen20. Anexpandable balloon12 is coupled with at least one of the two tubular members at or near the distal end ofsheath10. InFIGS. 2 and 3,balloon12 is coupled with both tubular members such thatinflation lumen22 opens distally intoballoon12. In this embodiment,balloon12 has a toroidal or “donut” shape, such thatballoon12 encirclesdevice passage lumen20, and anaperture15 inballoon12 allows one ormore treatment devices14 to extend from the distal end ofdevice passage lumen20 throughballoon12. Avisualization device24 is disposed withininflation lumen22 such that a distal portion ofvisualization device24, including anoptical element26, extends intoballoon12.Treatment device14 in this embodiment comprises a clip applier for applying tethered clips to a heart valve annulus, shown with a protrudingclip16 andclip tether18. Clip appliers for heart valve repair are described more fully in U.S. patent application Ser. No. 10/461043, previously incorporated by reference. Of course, any other suitable treatment device may alternatively be used withsheath10, such as a hook applier, a suture applier, an ablation device, a scalpel or other cutting device such as an electrocautery device, and/or the like.
• Innertubular member13 and outertubular member11 ofsheath10 may comprise any suitable material or combination of materials and may have any suitable shape, size, diameters, thicknesses and the like. In various embodiments, tubular members11,13 may be flexible along their entire lengths, rigid along their entire lengths or part-flexible, part-rigid. Themembers11,13 may be composed of one or more metals, such as Nitinol, stainless steel or titanium; flexible or rigid polymers, such as polyurethane, polytetrafluoroethylene (PTFE), other fluoropolymers, PEAX®, and/or the like; or any other suitable material or combination of materials. In some embodiments,tubular members11,13 may be rigidly fixed to one another, while in other embodiments one of themembers11,13 may be movable relative to the other. For example, in one embodiment outertubular member11 is slidably disposed over innertubular member13 so that it can retract proximally over innertubular member13 and then extend back distally to its original position.
• As shown inFIG. 3, a slidable outertubular member11 may allow the size ofballoon12 to be adjusted by a user.Balloon12 may be coupled with outer tubular-member11 at anattachment point30 such that sliding outertubular member11 proximally and introducing additional fluid or other inflating substance intoballoon12 will causeballoon12 to further expand. Any suitable configuration of balloon material andattachment point30 may be used. In one embodiment, for example, balloon material may be housed in a small slit or housing coupled with outertubular member11.
• In an alternative embodiment, outertubular member11 may be fixed, rather than slidable, and an outer, slidable sleeve (not shown) may be disposed over outertubular member11. The outer, slidable sleeve may be moved distally to contain part ofballoon12 and moved proximally to release part ofballoon12 to allow for additional expansion. Allowing a user to adjust the size ofballoon12 by sliding outertubular member11 proximally or distally and possibly by introducing additional inflation fluid may improve the users ability to visualize the surgical site. Balloon expansion, for example, may help exclude additional blood and/or push aside surrounding tissue from the surgical site.
• It may sometimes be advantageous to introduce a fluid substance intodevice passage lumen20 to cleanse devices, cleanseballoon12, clear an area around the surgical site and/or the like. In one embodiment, for example, saline may be introduced proximally with sufficient force to propel it forward (distally) throughdevice passage lumen20 to “flush”lumen20. Introduction of saline or other fluids may be accomplished via any suitable proximal inlet, such as a valve on a Y-connector device or the like.
• Balloon12 may have any suitable size, shape and configuration and may be made from any suitable expandable material. Although a toroidal balloon is shown inFIGS. 2 and 3, alternative embodiments may include a spherical, ovoid or otherwise shaped balloon disposed adjacent a lumen for instrument passage but not encircling the lumen. Such an embodiment is described further below with reference toFIG. 4. Similarly, any suitable inflation lumen may be included insheath10 for expandingballoon12. In some embodiments,inflation lumen22 is formed by the annular space between outertubular member11 and innertubular member13. Thus,inflation lumen22 may comprise a circumferential lumen. Alternatively, one or more tubular lumens may be disposed within the annular space between outertubular member11 and innertubular member13. Any means for inflatingballoon12 is contemplated within the scope of the invention. Typically,balloon12 is inflated by introducing a fluid, such as saline, intoballoon12 viainflation lumen22, although any other inflation technique or substance may be used.
• Similarly,device passage lumen20 may have any suitable size, diameter and the like and may be disposed in any location throughsheath10. Thus,device passage lumen20 may open intoaperture15 throughballoon12, or may alternatively open adjacent (but not through)balloon12.Lumen20 may allow passage of any suitable device or devices, such as asurgical clip applier14 for applyingclips16, coupled with atether18, to a heart valve annulus. In other embodiments, ablation devices, electrocautery devices, suturing devices, cutting devices, and/or the like may be passed throughdevice passage lumen20. Again, any and all suitable devices are contemplated.
• Sheath10 may also include one ormore visualization devices24. In some embodiments,visualization device24 is included as part ofsheath10, while in other embodiments, aseparate visualization device24 may be inserted intosheath10 by a user. These latter embodiments may allow, for example, a physician to use an already-owned visualization device or other device withsheath10.Visualization device24 itself may comprise any suitable device, such as a fiber optic device, an ultrasonic device, a charge coupled device, a camera, or the like. In embodiments wherevisualization device24 is included, it may be coupled withsheath10 in any suitable manner. For example,visualization device24 may be disposed withininflation lumen22 in such a way that it can move withinlumen22. In an embodiment as shown inFIGS. 2 and 3,visualization device24 may be movable around the circumference ofinflation lumen22, thus encirclingdevice passage lumen20. Such movement allows a user to acquire views of the surgical site from multiple angles.
• In some embodiments,multiple visualization devices24 or a visualization device disposed around a length of the distal end ofsheath10 may be used to visualize the site from multiple angles. To further enhance visualization, some embodiments may include a central processing unit (CPU) at or near the distal end ofsheath10 for processing images captured byvisualization device24. Processed images could then be transmitted proximally alongsheath10 to provide images to the user. For example, in one embodiment visualization may be achieved using a light source and one or more sensors or detectors disposed in a 360-degree array around an inner, device-passage lumen, the light source and the detectors disposed at the distal end of a visualization device. The sensors may then be coupled with a charge coupled device (CCD) disposed near the distal end of the device, the CCD being coupled with a wire that transmits data proximally along the visualization device.
• Althoughvisualization device24 is shown with a distal portion andoptical element26 extending intoballoon12, in other embodiments optical element may be flush with, or recessed into, the distal end of innertubular member13 and/or outertubular member11. Thus, there is no requirement that any visualization member extend intoballoon12. Such a configuration may be advantageous, in thatoptical element26 may be positioned closer to clipapplier14 or other devices and closer to the surgical site. If an angled optical element is used, it may be further advantageous to have the optical element facing centrally towards the surgical instrument(s) (or in another direction towards the instrument(s) in other embodiments).
• Referring now toFIG. 4, an alternative embodiment of asheath40 includes anouter tubular member42, aninflation lumen44, aballoon46, avisualization device48, and adevice passage lumen50 for allowing passage of one or moresurgical instruments52. In contrast to the earlier described embodiment,inflation lumen44 does not encircledevice passage lumen50, but instead the two lumens are adjacent one another. The two lumens may be placed at any suitable location throughsheath40 and may exitsheath40 at any suitable locations, though preferablyvisualization device48 will be relative close todevice passage lumen50 to allow for direct visualization of any surgical instruments passed through thelumen50. In an alternative embodiment,multiple inflation lumens44,multiple balloons46 and/ormultiple visualization devices48 may be included. As with the previously described embodiments, some sheaths will include one ormore visualization devices48 while others will simply allow for insertion of a user's visualization device.
• Methods of the present invention generally involve first advancingsheath10,40 to a location in the heart for performing a minimally invasive heart procedure, such as a mitral or tricuspid valve repair. Next,expandable balloon12,46 is inflated andvisualization device24,48 is used to visualize an area within the heart, locate an area for performing the surgical procedure, etc. The minimally invasive procedure may then be performed, using one ormore instruments14,52 extending throughdevice passage lumen20,50. During the procedure, real-time visualization may be acquired viavisualization device24,48. Even before the procedure,visualization device24,48 may be used to assess the surgical site, locate a particular structure such as a mitral valve annulus, and repositionsheath10,40 for better access to the site. In many embodiments,visualization device24,48 may be moved withinsheath10,40 and/or multiple visualization devices may be used to acquire images from different perspectives and angles. Multiple surgical instruments may be inserted and removed through sheath, various visualization devices may be inserted and removed, adjustments to the size ofballoon12,46 may be made, and/or the like. In some embodiments, the physician may also flush one or more portions of sheath with a fluid passed through one of the sheath's lumens. Any other suitable method steps may be added, steps may be skipped or combined, and or alternative steps may be substituted without departing from the scope of the invention.
• Although various embodiments of the present invention have been described fully above, this description is for exemplary purposes only and should not be interpreted to limit the scope of the invention. For example, various alterations, additions, substitutions or the like may be made to embodiments described above without departing from the scope of the invention. Therefore, none of the foregoing description should be read to limit the scope of the invention as it is defined in the following claims.
• Any and all patents, applications and printed publications mentioned above are hereby incorporated by reference.

Claims (22)

1-87. (canceled)

88. A device comprising:

an elongate member having a lumen extending therethrough; and

an expandable member connected to, and expandable from, the distal end of the elongate member, wherein the expandable member defines a continuous aperture along and through the entire longitudinal length of the expandable member when the expandable member is in the expanded configuration, the aperture having a diameter allowing for passage of at least one device for performing a heart procedure therethrough, wherein the device is selected from the group consisting of an ablation device, an electrocautery device, a suturing device, and a cutting device.

89. The device ofclaim 88, wherein the expandable member is frustoconical.

90. The device ofclaim 88, wherein the expandable member is toroidal.

91. The device ofclaim 88, wherein the expandable member is an inflatable balloon.

92. The device ofclaim 91, wherein the inflatable balloon comprises one or more inflation lumens.

93. The device ofclaim 88, wherein a diameter of the lumen is the same as the diameter of the aperture.

94. The device ofclaim 88, further comprising one or more visualization devices.

95. The device ofclaim 94, wherein the visualization device is selected from the group consisting of a fiber optic device, an ultrasonic device, a charge coupled device, and a camera.

96. The device ofclaim 88, wherein the elongate member is slidably disposed within an outer tubular member.

97. The device ofclaim 96, wherein the length of the expandable member is adjusted by sliding the outer tubular member along the elongate member.

98. The device ofclaim 88, wherein the elongate member is flexible.

99. The device ofclaim 88, wherein the elongate member is a catheter.

100. A method comprising:

advancing an elongate member having a lumen extending therethrough adjacent to heart tissue;

expanding an expandable member connected to, and expandable from, a distal end of an elongate member, wherein the expandable member defines a continuous aperture along and through the entire longitudinal length thereof; and

advancing at least one device through the continuous aperture where the device is selected from the group consisting of an ablation device, an electrocautery device, a suturing device, and a cutting device.

101. The method ofclaim 99, further comprising adjusting the size of the expandable member by sliding a sheath along the elongate member.

102. The method ofclaim 99, further comprising visualizing the location using a visualization device disposed within the expandable member.

103. The method ofclaim 99, wherein the heart procedure is mitral valve repair.

104. The method ofclaim 99, wherein the heart procedure is a laparoscopic procedure.

105. The method ofclaim 99, wherein the elongate member is advanced through the superior vena cava into the right atrium and through the interatrial septum.

106. The method ofclaim 99, wherein the elongate member is advanced through the inferior vena cava into the right atrium and through the interatrial septum.

107. A device comprising:

an elongate member having a lumen extending therethrough; and

an expandable member having a proximal end directly coupled to, and expandable from, the distal end of the elongate member, wherein the expandable member defines a continuous aperture along and through the entire longitudinal length of the expandable member when the expandable member is in the expanded configuration, the aperture having a diameter allowing for passage of at least one device for performing a heart procedure therethrough, wherein the device is selected from the group consisting of an ablation device, an electrocautery device, a suturing device, and a cutting device.

108. The device ofclaim 107, further comprising a visualization device disposed within the expandable member.

Images