METHODS AND DEVICES FOR CARDIAC SURGERY

Methods for performing minimally invasive heart surgery include accessing a heart of a patient through a first incision on the left thorax of the patient, contacting the heart through the incision with a heart stabilizing device and/or a heart positioning device, introducing at least one coupling device through a second incision on the patient located apart from the first incision, coupling the coupling device with the heart stabilizing device or the heart positioning device, and performing a surgical procedure on the heart. Systems may include a retractor device, a heart stabilizing device, and a coupling device, for enhancing cardiac surgery. Any suitable heart surgery may be performed using methods, devices or systems of the present invention. In one embodiment, a CABG procedure is performed.

DETAILED DESCRIPTION OF THE INVENTION

Devices, systems and methods of the present invention provide for enhancement of heart surgery procedures. Generally, the invention provides for accessing a patient's heart through an incision on the left thorax, introducing a heart stabilizing device and/or a heart positioning device through the incision, introducing one or more coupling devices through one or more separate incisions and coupling the coupling device(s) with the heart stabilizing device and/or the heart positioning device to stabilize and/or position the heart. Introducing one or more instruments through incisions that are separate from the main incision for accessing the heart provides a less cluttered surgical field, to provide the surgeon with enhanced visualization and room to insert additional instruments, manipulate instruments, manipulate the heart, operate on the heart, perform an anastamosis and the like. Various embodiments of the invention may be used in procedures involving a stopped heart and cardiopulmonary bypass, partial bypass, or in beating heart procedures.

Generally, any suitable devices or combinations of devices may be used with methods of the present invention. One embodiment, for example, may employ one or more retractors as described in U.S. Pat. No. 6,309,349, entitled “Surgical Retractor and Stabilizing Device and Method for Use,” the entire disclosure of which is hereby incorporated by reference. Some embodiments may include one or more of the following: heart stabilizing devices, such as those described in U.S. utility application Ser. No. 10/297,791, a National Stage Application of PCT/US01/04263; heart positioning devices, such as those described in U.S. Provisional Patent Applications 60/491,323, filed Jul. 29, 2003 and 60/519,837, filed Nov. 11, 2003; heart ablation devices, such as those described in U.S. Provisional Patent Application 60/519,726, filed Nov. 12, 2003; instrument stabilizing platforms, such as those described in U.S. Provisional Patent Application No. 60/519,221, filed Nov. 11, 2003; and/or the like. The entire disclosures of these applications are hereby incorporated by reference.

Referring now toFIG. 1, a schematic diagram of a patient10is shown adjacent a rail20of an operating room table, with a surgical system in position for enabling a heart surgery procedure. A surgical system may include, in one embodiment, a retractor device14for retracting skin and other tissues surrounding a thoracic incision12on patient10. The system may also include a heart stabilizing device18and/or a heart positioning device16, each of which may be coupled with a coupling device22,24. Each coupling device22,24may, in turn, be coupled with a flexible arm30,32, and each arm may be coupled with a stable object, such as rail20. The combination shown inFIG. 1and described herein is only one embodiment of such a system, however, and should not be interpreted as limiting the scope of the invention. In various embodiments, many different combinations of surgical instruments, stabilizing devices, coupling devices, retractor devices and the like may be used, without departing from the scope of the invention. Generally, therefore, any system for performing heart surgery in which a device or part of a first device is introduced through a first incision and second device is introduced through a second, separate incision and coupled with the first device is contemplated within the scope of the invention.

Generally, any suitable thoracic incision12may be used in accordance with the present invention. For example, incision12may be made between the 4th and 5th ribs in one embodiment. Once incision12is formed, retractor device14, or one or more alternative retractor devices, may be used to gain access to the patient's heart (not shown). In other embodiments, other access means may be used, such as any suitable incision(s), port(s), puncture site(s) or the like. Once the heart tissue is accessible, heart stabilizing device18and/or heart positioning device16are introduced through incision12and placed on the surface of the heart. The surgeon may then position the device(s)16,18on the heart at or near a desired location, or may wait until a later time to position the device(s)16,18. Next, one or more small, secondary incisions26,28are made at locations apart from thoracic incision12, typically at nearby locations on the patient's thorax, but suitably in other locations as well. The incisions may be small, stab-wound incisions of less than one inch in length, in some embodiments. In some embodiments, as inFIG. 1, two small incisions26,28are formed, to allow passage of two coupling devices22,24. Generally, any suitable incisions, ports, puncture sites, intravascular access sites, other access means or any combination thereof may be used.

A coupling device22,24, as described in further detail below, typically comprises an elongate shaft with means for coupling with stabilizing device18and/or positioning device16near the distal end of the shaft. Coupling device22,24, is introduced through a smaller incision26,28and advanced through the patient, under the skin, to position the distal end of the shaft at or near the surgical site, adjacent the heart. The coupling means are then used to attach coupling device22,24to stabilizing device18or positioning device16. In various embodiments, multiple coupling devices22,24may be introduced through one incision, heart stabilizing device18and heart positioning device16may be coupled with the same coupling device22,24, and/or additional heart contacting devices or coupling devices may be used without departing from the scope of the present invention. Any suitable combination of heart contacting devices and coupling devices is contemplated within the scope of the invention.

Once coupling devices22,24are coupled with stabilizing device18and positioning device16, coupling devices22,24may be used to position stabilizing and positioning devices18,16on the heart. Once in position, suction and/or other forces such as adhesives may be used to enhance contact between stabilizing and positioning devices18,16and the heart. In embodiments using suction, a source of suction, such as a cannula, may be introduced through one of the smaller incisions26,28or through the larger, thoracic incision12, depending on convenience and preference of the surgeon. In either case, a suction cannula is typically connected with heart stabilizing device18or heart positioning device16directly, rather than through coupling devices22,24. In some embodiments, however, one or more suction cannulas may be attached to coupling device22,24, to facilitate introduction of the cannula to the surgical site, to reduce cluttering of the surgical site, or for any other suitable purpose.

When coupling devices22,24have been coupled with heart stabilizing device18and heart positioning device16and the devices have been positioned on the heart and coupled with the heart via suction or other forces, each coupling devices22,24may then be coupled with one or more stable objects via a flexible arm32,30. Flexible arms may comprise any suitable devices for stabilizing coupling devices22,24. For example, arms32,30may comprise elongate, flexible members having distal clamps38,40at their distal ends and proximal clamps34,36at their proximal ends. Flexible arms30,32may comprise metallic arms having multiple joints, to allow flexibility while also being rigid enough to stabilize coupling members. In another embodiment, flexible arms30,32may be rigidifying, so that they may be manipulated into a desired position and then rigidified to hold their shape. In one embodiment, for example, arms30,32may be rigidified by applying suction. Flexible arms30,32may be coupled at or near their proximal ends, via proximal claims34,36or other coupling components to any stable object or objects. In one embodiment, for example, the stable object comprises a bed rail20, but any other suitable object may be used.

Any of the steps described above, as well as additional steps, may be performed in any suitable order, steps may be combined or eliminated, or the like, without departing from the scope of the present invention. For example, in one embodiment, thoracic incision12may be formed, smaller incision(s)26,28may be formed, coupling devices22,24may be advanced and then stabilizing device18and positioning device16may be placed into the surgical site and coupled with coupling devices22,24. In another embodiment, flexible arms30,32may be coupled with coupling devices22,24and with the stable object before being rigidified, while other combinations are possible in other embodiments. Furthermore, as mentioned above, additional or other devices than those described above may be used, fewer devices may be used or the like, without departing from the scope of the invention.

With reference now toFIG. 2, a surgical apparatus100for enhancing heart surgery suitably includes a coupling device101, coupled with a flexible arm114and a tissue stabilizing device130(or positioning device or other device). In one embodiment, coupling device101includes an elongate shaft110having proximal and distal ends (labeled arrows), which is coupled with a dial112or other actuation device at or near its proximal end and heart stabilization device130at or near its distal end. Flexible arm114generally comprises an elongate, flexible device with a clamp116at or near its distal end for coupling with coupling device101. Clamp116may alternatively comprise any suitable connective means.

Elongate shaft110of coupling device101is generally introduced into a patient through a minimally invasive incision122in the skin120, and is then advanced distally until the distal end of coupling device101is visible through a thoracic incision126over the heart124. Elongate shaft110may have any suitable configuration. In some embodiments, shaft110includes one or more flexible, rigidifying sections. In some embodiments, such sections may rigidify by applying a vacuum to that section of shaft. Other embodiments may use different rigidifying means. Distal coupling means118at or near the distal end of coupling device101may then be coupled with heart stabilizing device130via complementary coupling means132on device130. In one embodiment, distal coupling means118comprises a socket or collet and complementary coupling means132comprises a ball, or a ball on a post, which fits within distal coupling means118. In another embodiment, distal coupling means118comprises a clamp and complementary coupling means132comprises a rail or other feature onto which the clamp make take hold. Any suitable combination allowing coupling device101to attach to heart stabilization device130is contemplated. Various embodiments may include, for example, a male and female screw connection, a magnetic connection, an adhesive connection, a snap-fit connection, a pressure-fit connection or the like. At or near the proximal end of coupling device101, dial112may in fact comprise any actuation device, such as but not limited to a knob, trigger, slide or the like. Similarly, dial112may be used to perform any function or combination of functions with coupling device101. For example, in one embodiment dial112is used to tighten and loosen distal coupling means118to allow coupling device101to be coupled with, tighten around and release heart stabilizing device132. In other embodiments, dial112may control one or more alternative or additional functions. Once coupling device101is coupled with heart stabilizing device130, it may be used to position stabilizing device on the heart in a desired location and orientation.

With reference now toFIG. 2A, a coupling device distal end140is shown as an example of one embodiment of coupling means for coupling distal end140with a stabilizing device149or other suitable device. As previously mentioned, any suitable coupling means for connecting coupling device with a stabilization or other device is contemplated within the scope of the invention. Thus, a ball and socket joint, a ball and collet joint, any other suitable joint, an adhesive coupling means, a snap-fit or pressure fit coupling, or any other means may be used. For example, in yet another embodiment, as shown inFIG. 2A, distal end140includes a curved slot142and stabilizing device149includes a knob148which fits within slot142to provide coupling. In some embodiments, distal end140may also include a hollow lumen146, such as a lumen for use in applying a vacuum force, and a gasket144. In some embodiments, stabilizing device149also includes a hollow lumen150such that when stabilizing device149and distal end140are coupled together, the two lumens146,150are in fluid communication. This may allow vacuum, air, fluid and/or the like to be transmitted from the coupling device to the stabilizing device149. Such vacuum, for example, may be used to adhere a supporting foot152of device149to a surface of the heart.

In another embodiment, as shown inFIG. 2B, a distal end160of a coupling device may include female threads162which are complementary to male threads166on a stabilizing device169or other device. Again, distal end160may include a hollow lumen164and stabilizing device169may also include such a lumen168such that when they are coupled, the two lumens communicate. Again, one possible use of such communicating lumens164,168might be to provide vacuum or suction force at a foot170of stabilizing device169. Any other suitable configuration of distal ends, stabilizing devices (or other devices) and coupling means is contemplated within the scope of the invention. These examples are provided for descriptive purposes only and are not intended to limit the scope of the invention in any way.

Referring now toFIG. 3, a similar apparatus100to that described inFIG. 2is shown. In this embodiment, however, elongate shaft110of coupling device101includes multiple, flexible joints210. Flexible joints210may comprise ball and socket or ball and collet joints or may suitably include any other joint configuration. Joints210may provide coupling device101with enhanced flexibility and maneuverability within a patient to position the distal end of coupling device101in a desired location. Any number of joints210may be used and any position or combination of positions for joints210is contemplated. In some embodiments, dial112or one or more other actuators may be used to manipulate joints210. For example, joints210in some embodiments may be moved via an actuator and/or may be tightened, to reduce flexibility once coupling device101is in a desired position. To further enhance flexibility of apparatus100, a series of beads212or bearings may be incorporated into the distal end of coupling device101, into heart stabilizing device130or both. Any such flexible components may be used.

With reference now toFIG. 4A, a retractor device400for use in systems and methods of the present invention suitably includes a frame410, two or more retractor blades412coupled with frame410, and a crank408or other actuator coupled with frame410. Frame410may include two vertical rods and two horizontal rods that are slidably coupled with the vertical rods. Crank408may be used to move the horizontal rods relative to the vertical rods, to thus increase the distance by which blades412are separated and expand the width of an incision414. Blades412may comprise any suitable retractor blades and any number and size of blades412may be used. In some embodiments, retractor device400will be configured to assist in separating ribs416as well as incision414. Again, any number, configuration, size and the like of blades412may be used, and frame412may have any suitable shape, size and configuration. In some embodiments, only two or more blades may be used, without frame410.

Turning now toFIG. 4B, a side view of a portion of retractor device400is shown. In one embodiment, blade412includes a nerve protector420or detent. Nerve protector420is generally configured to apply pressure against rib416, without damaging an intercostal nerve422associated with rib416. As such, nerve protector420may have any suitable configuration and, in some embodiments, may include a soft or padded material, to allow blade412to adequately retract tissue and apply pressure against rib416without harming or damaging nerve422.

More generally, any retraction device or combination of retraction devices may be included as part of a system or method according to the present invention. In one embodiment, for example, an inflatable retractor may be used. For example, two blades of a retractor may be coupled to one another at opposite ends and may be inflated to allow a portion of each blade to expand, pushing the blades apart between their connected ends. In other embodiments, any combination of conventional retractors or retractors not yet conceived may be used.

Similarly, any heart stabilizing device, heart positioning device and/or any other device may be used as part of a system or method of the invention. As mentioned above, one heart stabilizing device may comprise the OPVAC® heart stabilizer (available from Estech, Inc., www.estechlics.com, the entire contents of said web site being hereby incorporated by reference). The heart positioning device may comprise the Pyramid Positioner™ device (also available from Estech, Inc.). Alternatively, any other suitable devices may be used. Thus, the present invention is not limited to heart stabilizing devices and/or heart positioning devices.

In one embodiment, an with reference now toFIG. 5, a stabilizing and/or positioning device comprises an inflatable heart retractor520or “pillow retractor.” Inflatable retractor520comprises an inflatable retractor surface522, coupled with an elongate shaft528via a flexible connector526. Again, shaft528is coupled with a rapid disconnect530, which may or may not include a flexible segment532. Inflatable retractor520also includes means for inflating the retractor surface522, which may comprise, for example, an inflation cannula524within or outside of elongate shaft528. Inflatable heart retractor520may be particularly advantageous in positioning the heart by placing the inflatable surface522in contact with a posterior portion of the heart and inflating the surface522to move the heart in an anterior direction—i.e., closer to the surgeon. Many alternate embodiments of inflatable retractor520may be developed within the scope of the present invention. Creating a space behind the heart may be very advantageous in visualizing the back of the heart and/or in maneuvering one or more surgical devices to operate on the back of the heart. Other variations of inflatable retractors may be found in U.S. Provisional Application No. 60/519,512, filed Nov. 12, 2003, the entire disclosure of which is hereby incorporated by reference.

Although the invention has been fully described above, in relation to various exemplary embodiments, various additions or other changes may be made to the described embodiments without departing from the scope of the present invention. Thus, the foregoing description has been provided for exemplary purposes only and should not be interpreted to limit the scope of the invention as set forth in the following claims.