Patent Document

RELATED APPLICATIONS 
       [0001]    This application claims priority of U.S. Provisional Application Ser. Nos. 60/555,308, filed Mar. 23, 2004; 60/635,652 filed on Dec. 14, 2004 and 60/636,449 filed on Dec. 15, 2004. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to an apparatus and method for connecting a conduit to a hollow organ, and more particularly, to a surgical device connectable to the apex of a heart. 
         [0004]    2. Description of the Related Art 
         [0005]    As the average age of the United States population increases, so do the instances of aortic stenosis. An alternative approach to the conventional surgical replacement of the stenotic aortic valve involves the use of an apicoaortic conduit. In this approach, the native aortic valve is not removed, and a prosthetic valve is implanted in a parallel flow arrangement. A connection conduit (or tube) connects the apex of the heart to the descending aorta. Somewhere along this conduit, the prosthetic valve is interposed. Thus, blood leaves the heart through the apex and travels through the conduit (with valve) to the descending aorta. 
         [0006]    Until recently, surgical procedures to implant an apicoaortic conduit have included a single, long incision, such as in the 6 th  intercostal space, to expose the heart and allow retraction of the lungs to expose the descending aorta. Recognizing the potential for broader scale use of the apicoaortic conduit for aortic valve replacement, some surgeons are now attempting to use smaller incisions and are requesting development of surgical tools for a minimally invasive procedure. As an initial attempt to make the procedure less invasive, some surgeons have recently performed the following procedure. 
         [0007]    The patient is placed on the table in the supine position. Anesthesia is induced, and the patient is intubated with a double-lumen endotracheal tube, this facilitates one-lung ventilation and allows the surgeon to work within the left chest. The patient is positioned with the left side up (90 degrees). The pelvis is rotated about 45 degrees, such that the femoral vessels are accessible. An incision is made over the femoral vessels, and the common femoral artery and vein are dissected out. Heparin is administered. Pursestring sutures are placed in the femoral artery and vein. The artery is cannulated first, needle is inserted into the artery, and a guidewire is then inserted. Transesophageal echo is used to ascertain that the wire is in the descending aorta. Once this is confirmed, a Biomedicus arterial cannula is inserted over the wire, into the artery (Seldinger technique). The arterial cannula is typically 19 or 21 French. Once inserted, the pursestring sutures are snugged down over tourniquets. A similar procedure is followed for the femoral vein. The venous cannula is usually a few French larger than the arterial cannula. Once both vein and artery are cannulated, the cannulae are connected to the cardiopulmonary bypass, and the capability to initiate cardiopulmonary bypass at any time is present. 
         [0008]    A 1 cm incision is made in approximately the 7 th  interspace in the posterior axillary line; the videoscope (10 mm diameter) is inserted, and the left chest contents viewed. The location of the apex of the heart is determined, and the light from the scope used to transilluminate the chest wall; this allows precise localization of the incision. The incision is then performed; it is essentially an anterior thoracotomy, typically in the 6 th  interspace. Recent incisions have been about 10 cm long, but are expected to become smaller and smaller with time. A retractor is inserted and the wound opened gently. A lung retractor is used to move the (deflated) left lung cephalad. The descending aorta is dissected free from surrounding soft tissue to prepare for the distal anastomosis. This dissection includes division of the inferior pulmonary ligament. A pledgeted suture is placed on the dome of the diaphragm and positioned to pull the diaphragm toward the feet (out of the way). The pericardium is incised about the apex of the heart, and the apex is freed up and clearly identified. 
         [0009]    On the back table, the apicoaortic conduit is prepared: a 21 freestyle valve is sutured to an 18 mm Medtronic apical connector. The valve is also sutured to a 20 mm Hemashield graft. The Dacron associated with the apical connector is pre-clotted with thrombin and cryoprecipitate. The assembly is brought to the field, and a measurement made from the apex of the heart to the descending aorta. The assembly is trimmed appropriately. A partial-occluding clamp is then placed on the descending aorta, and the aorta opened with a knife and scissors. The conduit (the end with the 20 mm hemashield graft) is then sutured to the descending aorta using 4-0 prolene suture, in a running fashion. Once this is complete, the clamp is removed and the anastomosis checked for hemostasis. Blood is contained by the presence of the freestyle aortic valve. The apical connector is placed on the apex, and a marker is used to trace the circular outline of the connector on the apex, in the planned location of insertion. Four large pledgeted sutures (mattress sutures) of 2-0 prolene are placed; one in each quadrant surrounding the marked circle. The sutures are then brought through the sewing ring of the apical connector. A stab wound is made in the apex in the center of the circle, and a tonsil clamp is used to poke a hole into the ventricle. To date, bypass has been initiated at this point, but doing so may not be necessary. A Foley catheter is inserted into the ventricle, and the balloon expanded. A cork borer is then used to cut out a plug from the apex. The connector is then parachuted down into position. A rotary motion is necessary to get the connector to seat in the hole. The four quadrant sutures are tied, and hemostasis is checked. If there is a concern regarding hemostasis, additional sutures are placed. The retractor is removed, chest tubes are placed, and the wound is closed. 
         [0010]    Surgical tools developed specifically to implant the apicoaortic conduit are expected to provide the means for a much less invasive procedure. The procedure is expected to be performed with a series of smaller thoracotomy incisions between the ribs, such as immediately over the apex of the heart. In addition to avoiding the median sternotomy, development of appropriate surgical tools is expected to avoid the need for cardiopulmonary bypass, so that the procedure can be performed on a beating heart. The diseased aortic valve does not need to be exposed or excised. The stenotic aortic valve is left in place and continues to function at whatever level it remains capable of, and the apicoaortic conduit accommodates the balance of aortic output. 
         [0011]    The major obstacle, to widespread adoption of this superior technique is the nearly complete lack of efficient devices to perform the procedure. Surgeons wishing to adapt the procedure must gather a collection of instruments from a variety of manufacturers. Often these instruments were created for quite different purposes, and the surgeon is forced to adapt them as required and manually manipulate them during a procedure. 
         [0012]    U.S. Published Patent Application 2003/0130668 A1 (Nieman) describes a method and apparatus for remotely cannulating a body part, such as a heart. The method and apparatus are endoscopic, i.e the instruments are mounted on the end of a long flexible member and inserted into the body through a trocar, i.e., a sharply pointed surgical instrument contained in a cannula. The endoscopic procedure is complicated. After the device is placed at or near the apex of the heart, the surgeon or some other controller performs at least 13 separate steps to secure the cannula in the heart wall. An attachment ring (which includes an apical ring and a locking stem) is sutured to the heart wall, and subsequently the cannula is connected to the attachment ring as a separate step. Because the procedure is endoscopic, imaging means (e.g., fluoroscopy) is used to place a balloon at the correct depth within the ventricle to provide occlusion. 
         [0013]    The complex endoscopic procedure disclosed in Nieman appears to require that the cut tissue core be removed from the body prior to advancing the cannula to the heart wall. Further, Nieman appears to provide two mechanisms for placing the cannula in the heart wall. One such mechanism is to create a hole that is large enough to easily slide the cannula into the hole. This does not provide a tight fit between the cannula and cored heart wall to prevent blood loss from the cored heart wall and from the ventricle and relies entirely upon the sutured attachment ring to achieve hemostasis thus providing a period of time during which there could be great losses of blood. The second mechanism is to achieve a tight (interference) fit between the cannula and cored hole. However, such a tight fit requires substantial axial and torsional forces to be applied to the cannula. The flexible endoscopic instrument disclosed in Nieman cannot provide such forces to be transmitted 
         [0014]    U.S. Patent Publication No. 2004/0162608 (Haverich) discloses a method and apparatus for implanting a conduit into the wall of a heart. As illustrated in  FIG. 8A , Haverich shows a conduit on a cutter that has a “corkscrew driver” with a coil. The corkscrew is rotated to cause the cutter to penetrate through the myocardium. However, substantial axial force is required to cleanly penetrate the myocardium, and such force is not easily applied by a corkscrew. Further, the pointed tip of the corkscrew can damage other areas of the heart wall (e.g., the septum) while applying axial force and rotation. Haverich discloses a balloon used for hemostasis. However, the balloon is a separate instrument that cannot be combined with the corkscrew. 
         [0015]    U.S. Patent Publication No. 2002/0045846 (Kaplon) discloses a device similar to Haverich except that a trocar is used to penetrate the organ wall instead of a cutter with corkscrew. No tissue plug is formed with a trocar. Use of a trocar makes it difficult to achieve hemostasis during a procedure-on a beating heart. To address this, rigid conduit  18  is inserted through the connector  16  after the connector is implanted with the trocar and sewn into place. Connector  16  does not appear to penetrate the heart wall. Connector  16  has a built-in valve to prevent blood loss after the trocar is removed and until conduit  18  is inserted 
       SUMMARY OF THE INVENTION 
       [0016]    A connector conduit according to the preferred embodiment includes a rigid apical connector portion which will serve to provide egress from the left ventricle (such as from the apex or lateral wall), a flexible conduit portion which will carry blood from the connector to the arterial system (such as to the descending thoracic aorta or the ascending thoracic aorta), and the aortic valve itself, which will be situated somewhere within the conduit. The present invention primarily addresses implantation of an apical connector with an attached length of conduit, referred to herein as the connector conduit (or connector). The connector conduit is implanted using an applicator. Although this discussion focuses primarily on the apex of the left ventricle, it is understood that the present invention can be used to implant a connector conduit to any wall of the left ventricle or other hollow organ. 
         [0017]    As described earlier, the surgeon conventionally uses a cork borer to cut a tissue plug from the ventricle wall. Once the tissue plug is removed, the surgeon must attempt to occlude the resulting hole, such as with a finger, a balloon or some other occlusion means, until the connector conduit is inserted. Despite attempts to occlude the resulting hole, substantial blood loss is inevitable. Cardiopulmonary bypass is used to reduce blood loss. 
         [0018]    An object of the present invention is to integrate the cork borer and connector conduit to form a system in which the connector conduit is inserted into the ventricle wall as the tissue plug is being created, thereby eliminating the need for a separate occlusion means and greatly reducing blood loss. Such integration may be achieved by mounting the connector conduit directly onto the outer diameter of a coring element or integrating the cutter and the connector conduit, which cuts the tissue plug and occludes blood flow through the inner diameter. In this way, the cross sectional area for blood loss is reduced to the gap between the coring element and connector conduit. 
         [0019]    Another object of the present invention is to combine the coring element with other features to form a complete applicator for securing the connector conduit into the ventricle wall. These features may include a mounting element and a handle element. The mounting element is an extension to the coring element that serves to add axial length to the coring element onto which the full length of the connector conduit may be mounted. The mounting element may be of the same diameter as the coring element. The handle element provides a grip to facilitate the necessary positioning, twisting and pushing force necessary to cut the tissue plug and to insert the connector into the ventricle wall. The handle could have a pistol handle shape, for example. 
         [0020]    Another object of the present invention is to provide the option for additional features for the complete applicator system for securing the connector conduit into the ventricle wall, particularly at the apex. These additional features may include a retractor element and a quick connect coupling element. 
         [0021]    The refractor element may have an expanding element for: 1) shaping the apex of the ventricle into a preferred shape for cutting the tissue plug, 2) providing a backing surface for the coring element in order to sandwich the heart wall between the coring element and expanding element, 3) pulling the tissue plug to within the coring element, and/or 4) ensuring that the tissue plug remains inside the coring element. The expanding element could be a liquid-inflated balloon sponge, or a mechanically-operated umbrella, as examples. 
         [0022]    The expanding element is mounted onto the retractor element, and the retractor element is slide-ably mounted within the coring element. A coupling element, such as a compression spring, provides the force to move the retractor element relative to the coring element. The retractor element may be designed to prevent relative rotation between the expanding element and coring element, thereby reducing the likelihood of damage to the expanding element. The retractor element may also include a section of increased diameter that abuts the outer heart wall to prevent premature or undesired cutting of the ventricle wall by preventing contact between the coring element and ventricle. 
         [0023]    Another object of the present invention is to provide an expanding element that has a similar look and feel as the conventional procedure. For example, the expanding element may be a balloon. A syringe element may expand the expanding element to a predetermined level by inflation with a liquid. To minimize the space required for the syringe, the balloon may be designed specifically to require minimal inflation volume while still performing the necessary functions of the expanding element. In addition, a filling element of the applicator may provide the means to fill the syringe element and balloon from an external liquid source and to provide the means to purge air from the expanding element. 
         [0024]    Another object of the present invention is to provide a connector conduit that has many of the features of the conventional apical connector (e.g., Medtronic™ apical connector) and includes additional features to make it compatible with the applicator and the surgical procedure. Additional features to make the connector conduit compatible with the applicator include 1) an ability to straighten the connector conduit from a bent configuration so that it will slide onto a straight mounting element, 2) a modified leading edge on the connector to ease insertion into the heart wall, and 3) a clamping element that includes portions of both the connector conduit and the applicator which serves to lock the connector conduit to the applicator in a predetermined position and to facilitate applying the twisting and pushing force necessary to insert the connector. 
         [0025]    An additional feature of the connector conduit to make it compatible with the surgical procedure is a quick connect coupler to expedite attachment of the connector conduit to the remainder of the prosthesis, which includes the prosthetic valve. The quick connect coupler is necessary to prevent a long time delay between implanting the connector conduit into the ventricle and achieving blood flow through the complete prosthesis. Such quick connect coupler may consist of a first part that is attached to the connector conduit and a second part that is attached to the remainder of the prosthesis, which includes the prosthetic valve. 
         [0026]    An additional feature of the connector conduit to make it compatible with the surgical procedure is to provide a length of conduit that may be collapsed, such as with an occlusion clamp, to prevent blood flow through the connector conduit before the quick connect coupler is connected and the surgeon is ready to allow blood flow through the complete prosthesis. 
         [0027]    In one configuration of the invention, expansion of the expanding element and the position of the retractor element are controlled independently by the surgeon. For example, if the expanding element is a balloon connected to a syringe, the volume of liquid in the balloon is controlled by the position of the plunger inside the syringe. Similarly, a bolt may be used to control the position of the retractor element relative to the coring element. In this configuration, the surgeon must independently control the positions of the syringe plunger and the retractor element bolt. 
         [0028]    Another configuration of the present invention provides a sequencing element (such as a cam mechanism) that ensures that critical steps of the procedure are performed in the proper sequence. The sequencing element synchronizes expansion of the expanding element with position of the retractor element. The sequencing element includes a sequencing bolt. The surgeon uses one hand to hold the applicator handle and the other hand to slide the sequencing bolt. In this way, independent control of the expanding and retractor elements is eliminated. Independent positions of these components are not user driven; rather, positions of these components are synchronized by the sequencing element. One example of a sequencing element is described next; however, it is understood that a sequencing element may be used to control fewer steps or additional steps of securing the connector conduit into the ventricle wall. 
         [0029]    The system is set up with the connector conduit mounted onto the applicator and with the retractor fully extended. The procedure begins by making a small knife wound in the apex and pushing the retractor element (with fully-deflated expanding element) through the heart wall and into the ventricle. The surgeon slides the sequencing bolt from a first position to a second position. Once the sequencing bolt is in the second position, the surgeon may release the sequencing bolt. The sequencing element ensures that this sliding motion serves to first expand the expanding element and, after the expanding element is fully expanded, to release the retractor element so that the retractor element can move the expanding element relative to the coring element. The surgeon may now use the handle to apply twisting and pushing force to place the connector conduit into the ventricle wall. During this time, the sequencing element simultaneously coordinates:
       a. application of compressive force between the expanding element and the coring element, thereby sandwiching and shaping the heart wall for cutting the tissue plug,   b. the coring element to cut a hole in the ventricle wall, thereby creating a tissue plug,   c. insertion of the connector conduit into the hole, and   d. the retractor element to retract the tissue plug from the hole into the coring element.       
 
         [0034]    Once the tissue plug is created, the sequencing element partially reduces the diameter of the expanding element so that the expanding element can enter the inner diameter of the coring element while remaining of large enough diameter to prevent the tissue plug from sliding off of the retractor element. This change in diameter of the expanding element occurs automatically to a pre-set intermediate diameter without attention from the surgeon. Once the surgeon has placed the connector conduit at the desired position within the ventricle wall, the applicator may be removed. 
         [0035]    In a preferred configuration, the connector conduit is a fabric (e.g., Dacron) covered device that is specifically designed for insertion into the wall of the left ventricle, such as at the apex. It contains a structural frame, a sewing flange (or suture ring) for attachment to the heart, and a standard fabric (e.g., Dacron) flexible vascular graft that extends through the lumen of the entire length of the structural frame and for some additional length beyond. An outer fabric may also cover the outside of the structural frame. The components of the connector conduit are interconnected, such as with polyester thread. The fabric may include orientation marks, such as a line along the length of the conduit. In addition, a quick connect coupling may be used to attach the connector conduit to the remainder of the prosthesis, which includes the prosthetic valve or ventricular assist device, as examples. 
         [0036]    A function of the structural frame is to provide mechanical integrity, i.e., rigidity, for the connector conduit. The structural frame may include a leading edge, a cage, a bend, and a holder. The leading edge is the first portion of the structural frame to be pushed through the heart wall. To minimize effort needed to push the connector through the heart wall, such leading edge may be tapered and/or beveled, for example. The cage is the portion of the structural frame that resides within the heart wall. The bend is the portion of the structural frame that holds the conduit in a preferred shape to direct blood flow from the left ventricle to the aorta, as described next in more detail. The holder is the portion of the structural frame that provides a means of mechanical connection between the connector conduit and applicator. 
         [0037]    The bend in the structural frame may be any appropriate angle (such as 90 degrees) to properly direct the conduit from the ventricle to the portion of the aorta where the conduit is to be connected. For example, the bend in the structural frame may be around 90 degrees if the conduit is to be connected to the descending thoracic aorta, or a larger angle bend may be used if the conduit is to be connected to the ascending thoracic aorta, for example. As described next, such bend may be flexible or rigid. 
         [0038]    In one embodiment, the bend of the structural frame may be flexible. For example, a set of equally-spaced circular rings mounted perpendicularly on a spine could form a bend that can flex to a range of angles. The circular rings provide radial support to prevent collapse of the conduit due to external forces. The spine may be at the outer radius of the bend or at the inner radius of the bend, as examples. In this embodiment, the bend can be straightened out from a preferred angle such that a mounting element of the applicator may be inserted straight through the lumen of the connector. Upon removal of the mounting element, if the bend is constructed of a material with a relatively high modulus of elasticity (e.g., PEEK), the connector returns to its bent configuration. If the bend is constructed of a material with a relatively low modulus of elasticity (e.g., polypropylene, polyethylene), the connector forms the bent configuration only when an external force is applied, such as by a bending means. Such bending means could involve pulling on threads that are weaved through the circular rings so that the bend is formed when the threads are pulled, for example. When the bend is at the preferred angle, the user may tie or crimp the threads together, for example, thereby preventing straightening of the bend. Such bending means allows the user to select any one of a plurality of possible bend angles as the preferred angle. Such bending means may also be used with a bend constructed of a material with a relatively high modulus of elasticity, such as to prevent straightening beyond the preferred angle. 
         [0039]    In another embodiment, the bend of the structural frame may be rigid. In this embodiment, since the bend cannot be straightened out, the bend must include a port such that the mounting element of the applicator may be inserted through such port and through the lumen of the cage. In this embodiment, the conduit must include a branch of additional conduit to form a Y. Such additional branch of conduit is coaxial with the cage for mounting the connector conduit onto the applicator. Once the connector conduit is implanted into the heart wall and the applicator is removed, the branch of conduit is occluded, such as by sewing or stapling the conduit closed, for example. The branch is then removed, such as by cutting with scissors. 
         [0040]    In another embodiment of the connector conduit, a quick connect coupler may be used to attach the connector conduit to the remainder of the prosthesis, which includes the prosthetic valve. The complete prosthesis may be divided into two parts: a first part that includes the prosthetic valve with lengths of conduit attached to both the upstream and downstream sides of the prosthetic valve and a second part that includes the connector conduit. The quick connect coupler allows the surgeon to rapidly connect said first part to said second part. In this way, the surgical procedure may be performed by first attaching said first part of the complete prosthesis to the aorta. Then, after the connector conduit is secured into the ventricle wall, the quick connect coupler allows rapid completion of the flow circuit to minimize the time between insulting the heart by cutting the hole and reducing the work load on the heart by allowing blood flow through the prosthesis. 
         [0041]    An applicator is used to implant the connector conduit into the ventricle wall. In a preferred embodiment, the applicator provides mechanical support on the surfaces of both the inner diameter and the outer diameter for some portion of the fabric-covered structural frame. Such support may be necessary to avoid unwanted distortion or movement of the structural frame while the connector conduit is being implanted through the heart wall. For example, the mounting element of the applicator, which is inserted straight through the lumen of the connector, may provide mechanical support (such as radial support) on the inner-diameter surface to reduce distortion of the structural frame during implantation. On the outer-diameter surface, the applicator may include a concentric tubular structure, referred to as the pushing element. The pushing element provides mechanical support (such as radial support) on the outer-diameter surface of the structural frame to reduce distortion during implantation. In a preferred embodiment, the mounting element and the pushing element are rigidly connected. 
         [0042]    In a related embodiment, an indexing means provides an interface between the pushing element and connector conduit that may prevent or greatly reduce rotation and/or axial movement of the connector conduit relative to the pushing element. As such, rotary or axial force applied to the pushing element is transmitted to the connector conduit through the locking means. An effective locking means may incorporate portions of the pushing element, mounting element and connector conduit. For example, the indexing means may include a slot-and-key arrangement that 1) positions the connector conduit at a preferred angle relative to the pushing element thereby orienting the bend in the structural frame, 2) prevents axial and rotary motion of the connector conduit relative to the pushing element, and 3) allows the connector conduit to be easy mounted onto and released from the applicator. Such indexing means may include a pushing element with an adjustable diameter that allows both rigid mounting and unhindered release of the connector conduit. Such indexing means may also include a connector conduit with a holder that locks to the pushing element, such as with a slot-and-key arrangement and/or with a tight friction fit, as examples. Such holder may be sandwiched firmly between the mounting element and pushing element. 
         [0043]    In a preferred configuration, the mounting element extends from a coring element that shares the same axis and has the same outer diameter as the mounting element. The coring element is used to cut a hole into the heart wall. Such coring element could consist of a thin-walled tube, the leading edge of which has been sharpened or serrated. The inner diameter of the connector conduit could fit snugly on the outer diameter of the coring element and mounting element. In use, the coring element could produce a hole in the heart wall that is smaller than the outer diameter of the connector conduit, thereby producing a snug fit. 
         [0044]    In a related embodiment, a handle may be rigidly attached to the pushing element. The handle may be at a substantially right angle after the manner of a pistol grip, for example. Such a handle attachment provides a more effective method of applying the insertion force and back-and-forth rotation needed to implant the connector conduit. 
         [0045]    In a preferred configuration, located concentrically within the mounting element is a retractor element consisting of a generally tubular structure having a pointed end that is inserted through the left ventricle wall. The tubular structure could be rigid. In a preferred embodiment, the pointed end of the retractor element could be a blunted point. In this way, after a small knife wound is made in the epicardium (outer surface of the heart), the blunted point could enter the knife wound and divide muscle fibers to penetrate the myocardium and left ventricle chamber. A purpose of the blunted point is to reduce the likelihood of damage should the point unintentionally contact other areas of the inner wall during use. In an alternative embodiment, the retractor element could include a very sharp pointed end being capable of producing its own entrance hole into the wall of the heart. Alternately, it could have a blunted point that would simply follow a previously created hole through the entire thickness of the ventricle wall. If so desired, the tubular structure of the retractor allows use of a guide-wire to follow a previously created hole. 
         [0046]    Near the pointed end of the retractor element is an expanding element, such as an inflatable balloon, an unfolding umbrella-like construction, an expandable collar, or similar structure. Once inside the ventricle, the expanding element is expanded from an initial diameter that may approximate the outer diameter of the retractor element to a second diameter. In a preferred configuration, the expanding element expands to a second diameter that is larger than the outer diameter of the coring element. The expanding element expanded to its second diameter seats snugly against the inside wall of the ventricle. Functions of the expanding element may include 1) expanding symmetrically to shape the inner wall of the ventricle into a preferred shape for cutting the tissue plug, and 2) fully retracting to within the coring element while remaining at least partially expanded. 
         [0047]    A first function of the expanding element is symmetric expansion, which provides at least two benefits. The first benefit is related to the variable, cone-shaped geometry of the left ventricular chamber near the apex. Symmetric expansion of the expanding element to a diameter that is larger than the outer diameter of the coring element effectively flattens out the ventricle wall in the vicinity of the apex so that the ventricle wall is more perpendicular to the sharpened leading edge of the coring element, thereby allowing the coring element to cut through the entire thickness of the ventricle wall. The tubular structure of the retractor element must resist the radial reaction forces from the ventricle walls. The second benefit of symmetric expansion is to ensure contact between the expanding element and the leading edge of the coring element along its entire circumference as the tissue plug is formed. Asymmetric expansion of the expanding element can result in formation of a plug with hanging attachments to the left ventricle wall. 
         [0048]    A second function of the expanding element is to fully retract and retain the plug within the coring element after the plug is cut. Such full retraction ensures that the applicator will slide out of the connector conduit (after the connector is implanted) without the plug and expanding element coming into contact with the inner diameter of the connector conduit. Such contact could increase the force required to remove the applicator from the connector conduit and could possibly result in debris from the removed plug being deposited on the inner diameter of the connector conduit. In addition, the expanding element must remain at a large-enough diameter after being retracted to within the coring element to ensure that the plug cannot slide off the end of the retractor element. 
         [0049]    In a related embodiment, this second function could include a coupling element that forces the retractor element to retract within the mounting element. In a preferred configuration, the coupling element could be a compression spring, for example. In this configuration, the retractor element could be slide-ably connected to the mounting element by means of the compression spring. The force produced by the compression spring tends to pull the expanding element snugly against the inside wall of the ventricle and to pull the tissue plug into the coring element after the tissue plug is detached from the ventricle. Alternatively, the user could manually provide the necessary force to retract the retractor element to within the coring element. 
         [0050]    In a preferred embodiment, the expanding element can be: 1) initially at a first diameter that approximates the outer diameter of the retractor element, 2) expanded to a second diameter that is larger than the outside diameter of the coring element, and 3) then reduced to a third diameter that is smaller than the inside diameter of the coring element but larger than the outer diameter of the retractor element. Inflation to the second diameter accommodates the first function of the expanding element (described above), and reducing to the third diameter accommodates the second function of the expanding element (described above). 
         [0051]    In a preferred embodiment, the expanding element is a balloon. The balloon may be inflated using an access means, such as a plunger in cylinder configuration (like a syringe) connected to the balloon by a flow passage, such as a channel integrated into the retractor element. An appropriate fluid to inflate the balloon could be saline, for example. The balloon material should be selected to best perform the functions of the expanding element. Polyurethane is a preferred material. Polyurethane is an elastic material that allows a balloon to be expanded symmetrically to as much as twice the original volume using a hand-held syringe. Such balloons are strong, abrasion resistant, and durable. Use of latex, another elastic material, is less desirable. Latex balloons typically expand asymmetrically, so use of a latex balloon as the expanding element could necessitate a means integrated into the balloon to ensure symmetric expansion. In the present invention, a latex balloon could be inflated to a symmetric diameter as determined by tension rods or sutures, for example, attached to the balloon and the retractor element. Once the tissue plug is formed, the plunger could be displaced to reduce the size of the balloon to allow retraction into the coring element. A means to prevent damage to the latex balloon by the coring element may be used. Alternatively, the balloon may be constructed of polyethylene terephthalate (PET; trade names include Dacron and Mylar), which is a non-elastic material. Balloons made of PET may be symmetrically inflated to higher pressures without appreciable change in the balloon volume. 
         [0052]    In one configuration of the present invention, expansion of the expanding element and the position of the retractor element are controlled independently by the surgeon. Consider the example of using a balloon as the expanding element. Inflation of such balloon could be fully controlled by the surgeon, such as by using a finger to displace a plunger inside a cylinder. In such case, the surgeon could inflate the balloon to any volume up to the maximum volume of the plunger/cylinder. Also in this configuration, the position of the slide-able retractor element relative to the coring element may be independently controlled by means of a bolt attached to the retractor element that passes through an indexed slot in the mounting element. In a preferred embodiment with the mounting element rigidly connected to a pushing element, the indexed slot could be in such pushing element. As the bolt is moved from one indexed position in the slot to another, the retractor is advanced or retracted relative to the coring element. In a preferred configuration with compression spring coupling between the retractor element and coring element, an indexed slot with the retractor element fully advanced (ready for insertion into the left ventricle wall) could be used. The bolt could then be manually released from the indexed slot after inflating a balloon on the retractor element. The compression spring would then pull the balloon firmly against the inner heart wall, thereby sandwiching the heart wall between the balloon and coring element. 
         [0053]    Independent control of the expanding element and retractor element could require increased surgeon training to ensure operation of these elements in the proper sequence. Alternatively, various latching or locking means could be used. For example, once the balloon has been inflated to a preset maximum volume, a latching means could lock the plunger into place, thereby preventing unintentional deflation of the balloon. If necessary, deflation to an appropriate volume for retraction into the coring element could be automatically triggered when the retractor element reaches a preset position during retraction. Alternatively, inflation and deflation of such balloon to preset maximum and reduced volumes could occur automatically, such sequence being initiated by pressing a spring-loaded trigger that displaces the plunger, for example. In addition, a safety latch or other means could prevent manual release of the bolt until the expanding element is fully expanded. These separate latching or locking means could result in a complicated mechanical configuration. 
         [0054]    In a preferred configuration of the present invention, a sequencing element, such as a cam mechanism, is used to coordinate expansion of the expanding element with position of the retractor element. Control of the expanding element and control of the retractor element position are coordinated so that the surgeon need only move a single sequencing bolt to control both the expanding element and the retractor element. The specific actions of the expansion element and retractor element that are controlled by the sequencing element may be chosen by the device designer to best accommodate the degree of control preferred by surgeons. 
         [0055]    In one embodiment of a preferred configuration that includes a sequencing element, the cylinder used to inflate/deflate the balloon (the syringe cylinder) may be integrated into the retractor element. Thus, the syringe cylinder, retractor element, balloon, and flow passage connecting the syringe cylinder to the balloon are integrated into a single component, referred to as the retractor assembly. The plunger used to inflate/deflate the balloon (the syringe plunger) may include a sequencing bolt extending radially from the plunger axis. Such sequencing bolt also extends radially through a slot in the syringe cylinder. As such, the slot in the syringe cylinder limits axial movement of the plunger in the syringe cylinder. By having a plurality of circumferentially interconnected slots of various axial lengths in the syringe cylinder, the degree of balloon inflation may be controlled by moving the sequencing bolt to a preferred axial slot. Synchronization of balloon inflation/deflation with motion of the retractor assembly relative to the pushing element (which is rigidly connected to the mounting element) may be achieved with two cam slots in the pushing element, for example. The first cam slot controls motion of a cam follower rigidly attached to the retractor assembly, thereby controlling the position of the retractor assembly relative to the pushing element. The second cam slot synchronizes inflation/deflation of the balloon relative to the position of the retractor assembly within the pushing element. The sequencing bolt serves as the cam follower in the second cam slot. Safety features may be integrated into the design of the cam mechanism. For example, the cam and follower can be designed to prevent movement of the retractor assembly relative to the pushing element (which is rigidly connected to the coring element) until the balloon is fully inflated. 
         [0056]    Various other features may be included to ensure safety and proper use of the connector conduit with applicator. For example, a port with a two-way valve may be integrated into the plunger/cylinder with balloon system to allow for filling with fluid and removal of air. As another example, a mounting tool may be used to mount the connector conduit over the coring element without damage to the fabric. As another example, a folding tool may be used to squeeze fluid from the balloon and to fold the balloon for use. As another example, the mounting tool and folding tool may be integrated into a single tool. 
         [0057]    The invention facilitates procedures using an integral device in which the various steps are preformed in a coordinated, i.e. sequenced manner. This renders the procedure simple and safe and reduces the likelihood of tissue damage or other complications. Other features and advantages of the invention will be apparent from the detailed description and from the claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0058]      FIG. 1  illustrates an apicoaortic conduit. 
           [0059]      FIG. 2A  is a perspective view of the structural frame of one embodiment of a connector shown in a bent configuration. 
           [0060]      FIG. 2B  is a perspective view of the structural frame of the connector of  FIG. 2A  shown in a straight configuration. 
           [0061]      FIG. 3A  is a cross-sectional view another embodiment of the structural frame of the connector, covered in fabric, with an incorporated sewing flange and shown in the bent configuration. 
           [0062]      FIG. 3B  is a cross-sectional view of the structural frame of the connector of  FIG. 3A  shown in a straight configuration. 
           [0063]      FIG. 3C  is a cross-sectional view of the connector of  FIG. 3A  shown in the straight configuration, and with a fabric conduit in place. 
           [0064]      FIG. 4  is a cross-sectional view of an embodiment of the device showing the coring element and the retractor element in place within the straightened connector. 
           [0065]      FIG. 5  is a cross-sectional view of a cylinder plug tool that slides over the retractor element and into the coring element, which is used to load the connector-conduit onto the coring element. 
           [0066]      FIG. 6  is a cross-sectional view of an embodiment of the device showing the placement of a compression spring between the retractor element and the coring element. 
           [0067]      FIG. 7  is a cross-sectional view of another embodiment of the device showing the placement of a pushing element. 
           [0068]      FIG. 8A  is a cross-sectional view of yet another embodiment of the device showing the attachment of a handle to the pushing element with an access means for the expandable element integrated into the pushing element, wherein the expandable element is shown contracted. 
           [0069]      FIG. 8B  shows the embodiment of  FIG. 8A  with the expandable element expanded. 
           [0070]      FIG. 9  is a cross-sectional view of an embodiment of the device showing the inclusion of a sliding bolt on the retractor element and related indexed slots on the pushing device. 
           [0071]      FIG. 10  is a partial view the pushing element of  FIG. 9  showing the indexed slots on the pushing device. 
           [0072]      FIG. 11A  is a perspective view of a flexible structural frame of another embodiment of the connector conduit shown in a straight configuration. 
           [0073]      FIG. 11B  is a perspective view of the structural frame of  FIG. 11A  shown in a bent configuration. 
           [0074]      FIG. 11C  is a perspective view of the structural frame of  FIG. 11B  shown with a beveled and tapered leading edge. 
           [0075]      FIG. 12  is a perspective view of an alternative embodiment of  FIG. 10B . 
           [0076]      FIG. 13A  is a perspective view of the flexible structural frame of  FIG. 11B  shown in the straightened configuration and incorporating a bending means. 
           [0077]      FIG. 13B  is a perspective view of the structural frame of  FIG. 13A  after activating the bending means. 
           [0078]      FIG. 14  is a perspective view of a non-bendable structural frame of a connector conduit. 
           [0079]      FIG. 15  is a cross-sectional view of a connector conduit shown in a bent configuration. 
           [0080]      FIG. 16  is a cross-sectional view of a non-bendable connector conduit. 
           [0081]      FIG. 17A  is a cross-sectional view of a mounting element (including a coring element) and a pushing element of the applicator with a loaded connector conduit. 
           [0082]      FIG. 17B  is a cross-sectional view  FIG. 17A  without the connector conduit. 
           [0083]      FIG. 18A  is a perspective view of a squeeze ring for a locking means to secure the connector conduit within the applicator. 
           [0084]      FIG. 18B  is a perspective view of a locking means shown in the locked position. 
           [0085]      FIG. 18C  is a perspective view of a locking means shown in the unlocked position. 
           [0086]      FIG. 19  is a cross-sectional view of the device of  FIG. 17B  including a retractor element. 
           [0087]      FIG. 20  is a cross-sectional view of a folding and mounting tool. 
           [0088]      FIG. 21  is a cross-sectional view of an assembly including an applicator having a syringe. 
           [0089]      FIG. 22A  is a cross-sectional view of a sequencing belt. 
           [0090]      FIG. 22B  is a cross-sectional view of the retractor body and expanding element. 
           [0091]      FIG. 22C  is a cross-sectional view of the positioning mans and coring element. 
           [0092]      FIGS. 23A-23C  the sequencing can mechanism in various states. 
           [0093]      FIGS. 24A-24E  illustrate the applicator in various states. 
           [0094]      FIG. 25  is a perspective view of an integrated connector conduit and cutting elements. 
           [0095]      FIG. 26  is the device of  FIG. 25  with the cutting element withdrawn. 
           [0096]      FIG. 27A-27D  illustrate components of a retractor having an expandable umbrella element. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0097]      FIG. 1  is an illustration of an apicoaortic conduit, which extends from the apex of the left ventricle to the descending aorta with a prosthetic valve positioned within the conduit. The preferred embodiment of the present invention includes aspects of the connector conduit and an applicator used to implant the connector conduit. 
         [0098]    The connector-conduit with applicator of the present invention is best described as consisting of five major parts: a connector-conduit, a retractor, hole forming device such as a coring element, a pushing component, and a handle. A fabric material pleated conduit of a type common and well known in the field is permanently fixed to the inner surface of a rigid connector to form the connector-conduit. The conduit extends from the forward edge of the connector and continues beyond the connector, as a flexible portion, for some distance. 
         [0099]    The connector-conduit includes a rigid portion defined by an internal support structure made of a suitably flexible material that is preferentially biased to assume a bent configuration (such as a right angle) upon removal of restraining forces. In one embodiment, the connector internal support structure is covered with fabric, such as knitted or woven Dacron, for example. A suturing ring is integrated into the covering fabric and provides a suitable flange for suturing the connector to the surface of the heart. The leading edge of the connector is tapered to facilitate insertion of the connector-conduit component. The “rigid” portion is rigid enough to facilitate insertion as described below and to maintain the hole in an open position. However, the rigid portion can be flexible. Accordingly, the term “rigid” as defined herein means relatively rigid and can include flexibility. 
         [0100]    As shown in  FIG. 2A , the structural frame  10  of the connector-conduit is a series of circular rings  14  joined to a curved spine  18 . During implantation, the curved spine  18  is straightened, as shown in  FIG. 2B , resulting in a straight pathway for the passage of instruments. As an alternative, the connector-conduit could include circular rings  14  without curved spine  18 . As such, the circular rings would prevent collapse of the conduit, but the curved conduit would be formed manually after implantation, rather than by being formed by the curved spine  18 . As another alternative, a modified coil spring in the shape of a curve could be used instead of circular rings  14  and curved spine  18 . Properties of the coil spring would be chosen to prevent radial collapse and to provide appropriate stiffness of the curved position. 
         [0101]    The leading edge of structural frame  10  is a taper  20  which allows for easy insertion of the connector through the ventricle wall. The material of the structural frame  10  could be a shape memory alloy (e.g., Nitinol), plastic, or other similar biocompatible material. 
         [0102]      FIG. 3A  illustrates a fabric covering  24  over the outside surface of structural frame  10 . Because connector surface  22  is in contact with the myocardial hole after implantation, a suturing ring or flange  26  is incorporated into the fabric covering  24  to provide an attachment site for sutures to anchor the connector to the heart. The fabric covered suture ring  26  could be made of a biocompatible foam or rubber. 
         [0103]      FIG. 3B  shows the fabric covered structural frame  10  and suturing flange  26  in a straightened position. The straightened position can be achieved by, for example, inserting a straight instrument through the lumen of the frame. Alternately, the structure can be held in the open position through the use of stay stitches  28 , or the like, placed such that the circular rings  14  are held in close proximity. 
         [0104]      FIG. 3C  is a view similar to  FIG. 3B , showing the structural frame in the straightened position with a pleated fabric conduit  30 . Conduit  30  extends from taper  20  of the structural frame  10 , through the length of the structural frame  10 , and for some additional length beyond the structural frame  10  to define a flexible portion of the connector conduit. An orientation marker (not shown) on connector surface  22 , for example, is used to identify the direction that conduit  30  will be oriented once implanted into the heart. The orientation marker is visible at all times to assist the surgeon while placing the connector-conduit  32  into the connector-conduit applicator and to facilitate implantation at an appropriate angle into the heart. Also, a radiopaque marker(s) (not shown) may be integrated into the entire length of fabric covering  24  and conduit  30  to facilitate identification and location of the structure by X-ray or other means. 
         [0105]    Referring to  FIG. 4 , in accordance with another embodiment of the present invention, a hole forming device such as coring element  40 , is placed concentrically within the lumen of the connector-conduit  32 . The coring element  40  preferably consists of a tubular structure, which could be made entirely of metal (such as stainless steel) or primarily of a plastic material with a metal insert for the leading edge  42 . In a preferred configuration, the leading edge  42  of coring element  40  may be suitably sharpened such that it cuts a plug of tissue of approximately the same diameter as the outer diameter of the coring element  40 . Note that the hole forming device can be any known mechanism for forming a hole, such as a laser cutter, a thermal ablation device, a chemical ablation device, or the like. 
         [0106]    An interference fit between connector surface  22  and the hole created by the coring element  40  is necessary to reduce bleeding from the cut myocardial surface and to reduce blood leakage from the left ventricle. The amount of such interference fit is the difference between the diameters of the hole created by the coring element  40  and the outer surface of the connector  22 . 
         [0107]    In a preferred embodiment of the device, the coring element  40  has an outer diameter that closely matches the inner diameter of the connector-conduit  32 . Such construction allows removal of the coring element  40  through the connector-conduit  32  while presenting only a small blood pathway between these two elements. Such construction is intended to minimize blood loss from the left ventricle when the coring element  40  has completed its cut. 
         [0108]      FIG. 4  further illustrates the concentric placement of the retractor element  50  within the coring element  40 . Retractor element  50  includes a blunt tip  52 , a tubular body  54 , an expanding element  56 , such as a balloon, and an access means  58  for engageably expanding element  56 . Access means  58  can be a plunger  58   a  in a cylinder  58   b  configuration, whereby displacement of the plunger expands or contracts expanding element  56 . A centering plug  60  is shown concentrically positioned within and rigidly attached to coring element  40 . The centering plug  60  concentrically positions retractor element  50 , which slideably moves within the centering plug  60 . The centering plug  60  also presents a barrier to the flow of blood through coring element  40 , once the tissue plug is formed. Proper placement of centering plug  60  within coring element  40  should consider tradeoffs between two different parameters. First, centering plug  60  should be placed at a position within coring element  40 , which allows ample space for the expanding element  56  and the tissue plug. Second, since radial force from the heart wall tends to deflect the expanding element  56 , retractor element  50  must have a sufficient stiffness to substantially resist such deflection. Such deflection may also be reduced by limiting the axial distance between the expanding element  56  and centering plug  60 . 
         [0109]      FIG. 5  shows a cylinder plug tool  45  for insertion into coring element  40  prior to loading connector-conduit  32  onto coring element  40 . Cylinder plug tool  45  facilitates loading connector-conduit  32  without damage from leading edge  42  of coring element  40 . Once the connector-conduit  32  is loaded, cylinder plug tool  45  is removed and placed aside. As a safety measure, cylinder plug tool  45  has an extended length with a tapered blunted end  45   a , which extends to cover retractor element  50 , preventing insertion of the retractor element  50  into the left ventricle before cylinder plug  45  is removed. 
         [0110]    Referring to  FIG. 6 , another embodiment of the present invention shows a compression spring  70  placed around the retractor element  50 . One end of the compression spring  70  seats on the centering plug  60 , and the other end seats on a sliding plug  72 . Sliding plug  72  is rigidly connected to retractor element  50 . Spring  70  ensures that expanding element  56  seats snugly against the inside wall of the ventricle to symmetrically displace the ventricle wall from the path of the coring element. Once the tissue plug is cut from the ventricle by coring element  40 , spring  70  also pulls the tissue plug fully within the coring element  40 . 
         [0111]      FIG. 7  illustrates a further embodiment, wherein a cylinder-shaped pushing element  80  is positioned concentrically outside the connector-conduit element  32 . Pushing element  80  is used to apply force to the coring element  40  and connector-conduit element  32 . This force is required for the coring element  40  to cut the hole in the myocardium and for pushing the connector-conduit element  32  into the hole. The end of the pushing element  80  that is in contact with the suture ring  26  has a roughened surface  82  intended to prevent relative rotary motion between the suture ring  26  and pushing element  80 . As such, the pushing element  80  allows both a force and a back-and-forth rotary motion to simultaneously be applied to the coring element  40  and connector-conduit element  32 , as required to fully seat the suture ring  26  flush with the surface of the heart. Pushing element  80  could be made of metal, plastic or other suitable material. 
         [0112]    Referring to  FIGS. 8A and 8B , a handle  90  is rigidly attached to pushing element  80 . As shown, handle  90  is configured similar to a pistol grip, for example, handle  90  having an angle of about 70 degrees, with the pushing element  80 . Handle  90  provides a user-friendly interface for the surgeon to hold with one hand, to position the coring element  40 , to apply axial force to the connector-conduit element and to provide a back-and-forth rotational motion of around 90 degrees. Of course, many alternatives exist for the user interface. For example, the pushing element  80  itself could be used as the handle. As another example, a handle could form a “T” shape on the end of the pushing element  80 . 
         [0113]    Also shown in  FIG. 8A , an access means  58  is used to expand or contract expanding element  56 . Access means  58 , for example, can be a trigger-type mechanism integrated into handle  90 . As such, the user can use a finger to pull plunger  58   a  into the cylinder  58   b , thereby displacing the fluid (such as saline) inside the cylinder  58   b  into the balloon  56 .  FIG. 8B  shows the inflation of the balloon  56 . As a safety feature, the plunger can have a latching device (not shown) that latches the plunger  58   a  with the balloon fully inflated, thereby preventing deflation of the balloon before intended. 
         [0114]      FIGS. 9 and 10  show a mechanism for controlling deployment of the retractor element  50 . A slot  84  is cut into pushing element  80 . Slot  84  has an index  84   a  to lock retractor element  50  at full extension and an index  84   b  to lock retractor element  50  at full retraction. Bolt  72   a  is rigidly attached to sliding plug  72 . Bolt  72   a  can be manually displaced within slot  84  to position the retractor element  50 . In operation, bolt  72   a  is positioned in index  84   a  until the retractor element  50  is fully inserted into the left ventricle and the expanding element  56  is at full expansion. At that time, bolt  72   a  is manually released from index  84   a , which allows compression spring  70  to retract retractor element  50  until expanding element  56  contacts the inside wall of the left ventricle. A damping means (not shown) may be included to prevent sudden retraction of the retractor element upon release from index  84   a . Also not shown is a safety latch or other means to prevent manual release of the bolt  72   a  until the expanding element  56  is fully expanded. 
         [0115]    As the surgeon applies force and rotation using handle  90 , compression spring  70  continues to displace retractor element  50 . When retractor element  50  is fully retracted, the surgeon can rotate bolt  72   a  into index  84   b  to lock the retractor element  50  in place. Moreover, when retractor element  50  is fully retracted, the expanding element  56  is also fully retracted into coring element  40 , indicating that the tissue plug has been successfully removed from the left ventricle and is within the coring element  40 . 
         [0116]    Referring to the embodiment of  FIGS. 11A-11C , the connector conduit has a structural frame  101  defining a rigid portion, which may be constructed from a single material or a combination of materials. The structural frame  101  includes a tapered leading edge  110  designed to reduce the effort needed to push the connector through the heart wall located at one end of a cage section  120  and a bend portion  140  that is normally biased into a bent configuration. As shown in  FIG. 11C , a tapered and beveled leading edge  150  may further reduce the required effort. During use, cage  120  resides primarily within the heart wall, so it must be constructed so as to be rigid enough to not collapse due to radial forces exerted by the heart wall. The cage  120  may include cage slots  121 . The cage slots  121  allow the passage of thread to secure the conduit or the sewing flange. 
         [0117]    A holder  130  is formed at one end of cage  120  and may be used to grasp the connector during implantation. As will be described further herein, holder  130  can have a slot-and-key configuration with the applicator. As such, the holder  130  utilizes holder slots  431  or a holder button  430  ( FIG. 12 ). Holder button  430  may be a separate part that is anchored (e.g., by thread or glue) to structural frame  101 . If desired, the holder slots  431  or holder button  430  may be designed to place the flexible bend  140  or rigid bend  145  ( FIG. 14 ) at a preferred angle relative to the applicator. Alternatively, the holder  130  may rely upon a tight friction fit with the applicator. In a preferred configuration, the holder  130  relies upon both a slot-and-key and a tight friction fit to lock the holder  130  relative to the applicator. 
         [0118]    Referring again to  FIGS. 11A and 11B , bend portion  140  includes circular rings  141  and a curved spine  142 . The circular rings  141  prevent radial collapse of the conduit, and the curved spine  142  holds the conduit in a preferred shape to direct blood flow from the heart to the aorta. The curved spine  142  may be at the outer radius of bend portion  140  (as shown) or at the inner radius of the flexible bend. As an alternative, flexible bend  140  may include two curved spines at the mean radius. As another alternative, the structural frame  101  could include circular rings  141  without curved spine  142 . As another alternative, a modified coil spring in the shape of a preferred bend could be used instead of circular rings  141  and curved spine  142 . Properties of the coil spring would be chosen to prevent radial collapse and to provide appropriate stiffness of the curved position. 
         [0119]    The structural frame of  FIGS. 11A-12  is intended for mounting onto the outer diameter of a straight mounting element. As such, the bend portion  140  must be constructed to allow straightening of the curved spine  142 . If curved spine  142  is made of a material or combination of materials with higher modulus of elasticity (e.g., PEEK, metal), the flexible bend  140  is stiffer. As such, the flexible bend  140  may be biased to resume a preferred shape (e.g., a 90° bend) when removed from the mounting element. If the curved spine  142  is made of a material with a lower modulus of elasticity (e.g., polypropylene, polyethylene), the bend portion  140  is less stiff. As such, the bend portion  140  may be biased relatively straight when removed from the straight mounting element. In such case, some bending means may be needed to position the bend portion  140  into the preferred shape. 
         [0120]    One embodiment of a bending means is shown in  FIGS. 13A and 13B , which illustrate use of threads  143  that are secured to the holder  130  (for example) and weaved through circular rings  141 . When threads  143  are pulled, the bend portion  140  changes from the normally biased, straight configuration of  FIG. 13A  to the bent configuration of  FIG. 13B . When the flexible bend  140  reaches the preferred shape, the threads may be tied to form a knot or crimped. If desired, the bending means can be used with a curved spine  142  constructed of a high modulus of elasticity material to prevent straightening beyond the preferred angle. 
         [0121]    As discussed previously, structural frame  101  may be constructed with a fixed bend  145 , as shown in  FIG. 14 . A port  146  allows the mounting of structural frame  101  with a fixed bend  145  onto a straight mounting element. 
         [0122]      FIG. 15  is a cross-section of a connector conduit  100  that includes a rigid portion defined by structural frame  101  with bend portion  140 , and a flexible portion defined by conduit  160 . The rigid portion also includes outer fabric  161 , and sewing flange  170 . Orientation marks (not shown) may be included on the conduit  160  or outer fabric  161 . Conduit  160  may be a pleated vascular graft constructed of woven Dacron. Outer fabric  161  could be a knitted Dacron fabric material that stretches to accommodate contours of the structural frame  101 . Sewing flange  170  could be constructed of a soft silicone rubber, for example, to allow easy passage of a needle when fastening sewing flange (or sewing ring)  170  to the outer surface of the heart. To allow visualization on x-ray, for example, the sewing flange could be made radiopaque, such as by mixing barium sulfate into the silicone rubber. The sewing flange may have a cloth covering such as that used for outer fabric  161 . Alternatively, the sewing flange  170  may consist entirely of folded cloth. The components of the connector conduit  100  may be fastened together as needed, such as with thread. 
         [0123]    Referring to  FIG. 16 , a cross-section of a connector conduit  100  is similar to that shown in  FIG. 15 , except that the structural frame  101  is constructed with fixed bend  145 . A conduit branch  162  intersects with conduit  160  through port  146  of rigid bend  145  to allow passage of a straight mounting element through the connector conduit  100 . Once the connector conduit  100  is implanted into the ventricle, branch  162  may be occluded at the intersection with conduit  160 . Branch  162  may then be cut off. 
         [0124]      FIG. 15  and  FIG. 16  further illustrate a quick connect coupler  180  for expediting attachment of the connector conduit  100  to the remainder of the prosthesis, which may include a prosthetic valve or ventricular assist device, as examples. As shown, the male end of quick connect coupler  180  is a continuation of or is attached to vascular graft  160 . The male end of quick connect coupler  180  includes rigid connector frame  181 , which may be constructed of a biocompatible plastic or metal. Vascular graft  160  covers the inner diameter of connector frame  181 , and an outer fabric  165  covers the outer diameter of connector frame  181 . Outer fabric  165  may be continuous with vascular graft  160 . Outer fabric  165  is not of a pleated construction, such as is typical of vascular graft  160 . The cloth-covered connector frame  181  provides a rigid surface onto which the female end of quick connect coupler  180  may be mounted. The female end of quick connect coupler  180  includes vascular graft  186  and pull ring  185 . Vascular graft  186  attaches on its downstream end to the remainder of the prosthesis, which may include a prosthetic valve or ventricular assist device, as examples. Vascular graft  186  may be a pleated vascular graft constructed of woven Dacron, for example. Graft extension  186   a  is a continuation portion of or is attached to vascular graft  186 . A rigid pull ring  185  (which may be constructed of a biocompatible plastic or metal) is attached to graft extension  186   a . The male end of quick connect coupler  180  has a larger outer diameter than vascular graft  186 . This construction provides a stop so that the male end of quick connect coupler  180  reaches an abrupt change to a smaller diameter provided by vascular graft  186 . In this way, the surgeon knows when the male end is fully inserted into the female end of quick connect coupler  180 . In use, the surgeon may grasp pull ring  185  with one hand and connector frame segment  181   a  of connector frame  181  with the other hand. Pull ring  185  is pulled over outer fabric  165  until the male end of quick connect coupler  180  contacts the smaller diameter vascular graft  186 . A large suture or umbilical tape  187  may then be tied around graft extension  186   a  to reduce blood loss by occluding the annular gap between the outer diameter of outer fabric  165  and the inner diameter of graft extension  186   a . Stay sutures may also be used to connect outer fabric  165  to graft extension  186   a , thereby preventing separation of the male and female ends of quick connect coupler  180 . 
         [0125]      FIG. 15  and  FIG. 16  further illustrate a collapsible portion  160   a  between connector conduit  100  and quick connect coupler  180 . Such collapsible portion  160   a  allows use of a cross clamp, for example, to fully collapse portion  160   a  to occlude flow after the applicator is removed beyond collapsible portion  160   a . Collapsible portion  160   a  can be made of the same material as the rest of the flexible portion, or can be made of a different material. 
         [0126]    In use, the applicator of the present invention is used to implant the connector conduit  100  into the ventricle wall or other organ wall.  FIG. 17A  shows a cross-section of the connector conduit  100  ( FIG. 15 ) loaded onto a mounting element  200 . For clarity, the applicator is shown without the connector conduit  100  in  FIG. 17B . Mounting element  200  includes a cylindrical coring element  210 , serving as a hole forming element, that is concentric with and has the same diameter as the mounting element  200 . The mounting element  200  and coring element  210  are placed concentrically within the lumen of the connector conduit  100 . Coring element  210  includes a thin-walled tube and a sharpened cutting edge  210   a , which may be tapered on the inner diameter, for example, to form the sharpened cutting edge  210   a . The coring element  210  is used to cut a cylindrical-shaped core (or hole) in the heart wall, producing a plug from the heart wall that resides within the coring element  210 . The mounting element  200  could be constructed of plastic (e.g., ABS), and the coring element  210  could be constructed of metal (e.g., stainless steel). In a preferred embodiment, the mounting element  200  and coring element  210  have an outer diameter that closely matches the inner diameter of the connector conduit  100 . One purpose of such a construction is to minimize blood loss from the left ventricular chamber when the coring element  210  has completed its cut. Also in order to reduce blood loss from the left ventricular chamber and from the cut myocardial surface and to yield a snug fit of the connector conduit within the ventricular myocardium, the cutting diameter of the coring element  210  is chosen to produce a core that is smaller in diameter than the outer surface  163  of the of the connector conduit  100 . 
         [0127]      FIG. 17A  and  FIG. 17B  further illustrate a cylinder-shaped pushing element  300  positioned concentrically outside the connector conduit  100 . In a preferred embodiment, the pushing element  300  transmits pushing force and rotation to the connector conduit  100 . In further accordance with a preferred embodiment, the pushing element  300  is rigidly attached to mounting element  200 , such that pushing element  300  transmits pushing force and rotation to the mounting element  200  and coring element  210 . Pushing element  300  may be constructed of plastic (e.g., ABS) or metal (e.g., stainless steel). However, it should be appreciated that the present invention contemplates the use of other materials. 
         [0128]    In further accordance with a preferred embodiment, a locking means provides an interface that prevents movement of the connector conduit  100  relative to the pushing element  300 . Such locking means may include components that are integral with the pushing element  300 , connector conduit  100 , mounting element  200 , and coring element  210 .  FIGS. 18A to 18C  illustrate one embodiment of such a locking means. This embodiment combines a slot-and-key arrangement with a friction enhancing arrangement. The slot-and-key arrangement includes notch  421  (the slot) of pushing element  300  and holder button  430  (the key) of structural frame  101 . Positioning holder button  430  into notch  421  prevents rotation of connector conduit  100  relative to pushing element  300  and prevents axial motion in one direction. Axial motion allowing removal of the connector conduit  100  from the applicator is not prevented in this embodiment. Rather, this axial motion is reduced by providing a friction enhancing arrangement consisting of squeeze ring  410  (which includes two groove pins  411 ) and squeeze arms  425   a  and  425   b  that cantilever from pushing element  300  to form wide groove  420   a  and narrow groove  420   b . Alternatively, notch  421  could fit tightly around the circumference of holder button  430  to prevent movement of the connector conduit  100  relative to the pushing element  300  in both rotational and axial directions. As shown, notch  421  is divided, with one half cut from squeeze arm  425   a  and the other half from squeeze arm  425   b . Alternatively, notch  421  could reside entirely within either squeeze arm. Alternatively, several notches  421  could be used. 
         [0129]    When squeeze ring  410  is positioned at or near notch  421  as shown in  FIG. 18B , squeeze ring  410  holds squeeze arms  425   a  and  425   b  tightly against connector conduit  100 , creating a tight friction fit. In this position, groove pins  411  within wide groove  420   a  do not tend to separate squeeze arms  425   a  and  425   b . When squeeze ring  410  is positioned as shown in  FIG. 18C , groove pins  411  within narrow groove  420   b  tend to separate squeeze arm  425   a  and  425   b  to allow the connector conduit to be easily moved into position or removed. In a similar embodiment (not shown), the slot-and-key arrangement could include teeth (keys) that extend radially inwards from the inner diameter of squeeze arms  425   a  and  425   b  to fit into holder slots  431  of holder  130  of structural frame  101  (see  FIG. 11A ). In this embodiment, a squeeze ring (with groove pins) and squeeze arms similar to those shown in  FIGS. 18A to 18C  would be used to engage and disengage the teeth from holder slots  431 , rather than to provide a tight friction fit. 
         [0130]    In accordance with a further embodiment of the present invention, a retractor component element  500  with a generally tubular structure is located concentrically within the mounting element  200 , as shown in  FIG. 19 . The retractor element  500  can slide axially relative to the mounting element  200 . The retractor element  500  consists of a blunt tip  510 , a tubular body  520 , and an expanding element  530  that includes an access passage  531 . The expanding element  530  is shown as a balloon in  FIG. 19 , which may be inflated and deflated with fluid (e.g., saline) through access passage  531  using a plunger and cylinder arrangement. 
         [0131]    Retractor element  500  is held concentric within the mounting element  200  by centering plug  220  and sliding plug  521 . Centering plug  220  is rigidly attached to mounting element  200 , and sliding plug  521  is rigidly attached to tubular body  520 . Since radial force from the heart wall tends to deflect the expanding element  530 , tubular body  520  must have a sufficient stiffness to substantially resist such deflection. Such deflection may also be reduced by limiting the axial distance between the expanding element  530  and centering plug  220 . 
         [0132]    A coupling element, such as compression spring  540 , slideably couples retractor element  500  to mounting element  200 . Compression spring  540  biases refractor element proximally to ensure that expanding element  530  seats snugly against the inside wall of the ventricle to shape and partially flatten the ventricle wall (particularly at the apex) so that coring element  210  may cut perpendicular to the ventricle wall. Once the tissue plug is cut from the ventricle by coring element  210 , spring  540  pulls the tissue plug fully within the coring element  210 . In the preferred embodiment, expanding element  530  is a balloon in the shape of a circular torrid. 
         [0133]      FIG. 20  illustrates a mounting and folding tool  900 , which includes coring element taper  910 , balloon taper  920 , conduit taper  930 , and retractor element port  940 . Tool  900 &#39;s outer diameter may be equal to or slightly larger than coring element  210 &#39;s outer diameter to prevent damage to fabrics of the vascular graft  160  and outer fabric  161 , when the connector conduit  100  is being mounted onto or demounted from mounting element  200 . As an alternative, a thin-walled tube, such as a plastic shrink rube, may be positioned over outer diameters of tool  900  and coring element  210  to further prevent damage to fabrics slid past the sharpened edge  210   a  of the coring element. Coring element taper  910  fits snugly within coring element  210  to ensure a concentric fit between tool  900  and coring element  210 , thereby further reducing the likelihood of damage to vascular graft  160  and outer fabric  161 . Conduit taper  930  eases placement of vascular graft  160  onto tool  900 . Tool  900  may be used to deflate and fold expanding element  530  by placing tool  900  onto retractor element  500  and by pushing and rotating (in one direction) tool  900  until coring element taper  910  contacts coring element  210 . Balloon taper  920  provides a surface for controlled deflation and folding of the expanding element  530 . Once the balloon is deflated and folded and the connector conduit  100  is fully mounted onto the applicator, tool  900  may be removed. 
         [0134]      FIG. 21  illustrates an embodiment of an applicator assembly (connector conduit  100  not shown). In this assembly, the surgeon has independent control of the position of retractor element  500  and the volume of expanding element  530 . Handle  310 , which extends from pushing element  300  to form a pistol grip, provides a means for the surgeon to apply axial force and back-and-forth rotary motion while implanting connector conduit  100 . The position of retractor element  500  is controlled by the position of retractor bolt  522  in slot  320  of pushing element  300 . Retractor bolt  522  is rigidly attached to sliding plug  521  of retractor element  500 . Slot  320  is extended circumferentially to form index  321 , which may be used to hold the retractor element  500  fully extended (i.e., with expanding element  530  at maximum distance from coring element  210 ). Expanding element  530  is connected to cylinder  562  by access passage  531  and flexible tube  550 . Expanding element  530  volume is controlled by the position of plunger  600  in cylinder  562 . Cylinder  562  is oriented in handle  310  so that plunger  600  with trigger  563  forms a pistol handle with trigger arrangement. Expanding element  530  can be inflated with saline, when trigger  563  is squeezed. Plunger spring  565  may be used to deflate expanding element  530  when the trigger is released. Alternatively, trigger  563  could be replaced with a finger ring so that the user must apply force to control both inflation and deflation of expanding element  530 , thereby eliminating the need for plunger spring  565 . As a safety feature, the plunger  600  may include a latching device (not shown) that latches the plunger  600  with the balloon fully inflated, thereby preventing premature deflation of the balloon. A related safety feature may include another latching device (not shown) that latches plunger  600  with the balloon partially inflated, such as to prevent the tissue plug from coming off of retractor element  500 . As one of many alternatives to handle  310 , the handle could form a “T” with pushing element  300 . 
         [0135]    In operation, retractor bolt  522  is positioned in index  321  until the retractor element  500  is fully inserted into the ventricle and expanding element  530  is fully inflated. At that time, retractor bolt  522  is manually released from index  321 , which allows compression spring  540  to retract retractor element  500  until expanding element  530  contacts the inside wall of the ventricle. A damping means (not shown) may be included to prevent sudden retraction of the retractor element  500  upon release from index  321 . Also not shown is a safety latch or other means to prevent manual release of the retractor bolt  522  until the expanding element  530  is fully expanded. As the surgeon applies force and rotation using handle  310 , compression spring  540  continues to displace retractor element  500 . When retractor element  500  is fully retracted, expanding element  530  is also fully retracted to within coring element  210 , indicating that the tissue plug has been successfully removed from the left ventricle and is within the coring element  210 . 
         [0136]      FIG. 22A  to  FIG. 22C  are components of a preferred embodiment shown in  FIGS. 24A-24E , that uses a sequencing element to coordinate the position of refractor element  500  with the expansion of expanding element  530  ( FIG. 22B ). In this embodiment, the sequencing element is a cam mechanism. The cam mechanism helps to ensure proper use of the applicator during implantation of connector conduit  100  (not shown). As shown in  FIG. 22B , retractor element  500 , referred to as the retractor assembly, includes cylinder portion  562  integrated therein. The retractor assembly is positioned concentrically within pushing element  300  during use. The retractor assembly contains elements of the cam mechanism formal therein, including cylinder cam slot  710 , which is a slot cut completely through the cylinder  562  wall, and a refractor cam follower  760 , which may be a pin or screw in cylinder  562  (as shown) or may be an integral part of cylinder  562 . Retractor element  500  may include a section of increased diameter such as stopper disk  515  to prevent cutter element  210  from cutting the heart when retractor element  500  is initially inserted.  FIG. 22A  illustrates plunger  600  (in the form of a sequencing bolt as described below), which is positioned concentrically within cylinder  562  during use. Plunger  600  contains elements of the cam mechanism, including bolt portion  650  with plunger cam follower  750 . Plunger cam follower  750  moves within cylinder cam slot  710  and pusher cam slot  720 . Plunger  600  includes passage  610  and purge/fill valve  630  (valve body not shown). Valve  630  can be opened to allow fluid flow into and out of passage  610 . When closed, valve  630  allows no fluid flow in either direction. Valve  630  may be connected (such as with a catheter) to a reservoir of saline, for example, to purge the expanding element  530 , access passage  531  and any other volume in the flow circuit of air before filling these volumes with fluid (such as saline). O-ring groove  620  of plunger  600  contains an o-ring (not shown) to prevent loss of fluid. 
         [0137]      FIG. 22C  illustrates a positioning assembly, which is made up of rigidly connected components including pushing element  300 , cutting element  210 , and handle  310 . The pusher assembly contains elements of the cam mechanism, including pusher cam slot  720  and retractor cam slot  730 . The pusher cam slot  720  is a slot cut completely through the pushing element  300  wall to accommodate plunger cam follower  750 . 
         [0138]      FIG. 23A  to  FIG. 23C  illustrate operation of the cam mechanism.  FIG. 23A  illustrates cylinder cam slot  710  cut into cylinder  562  of  FIG. 22B . Cylinder cam slot  710  contains three interconnected axial cam slots at angles  1 ,  2  and  3  around the circumference of cylinder  562 , as further illustrated in  FIG. 23C . The axial cam slot at each angle corresponds to a range of allowable axial positions of plunger  600  within cylinder  562 . At angle  1 , the axial length of the cam slot corresponds to the maximum stroke of plunger  600  within cylinder  562 . This maximum stroke allows filling the expanding element  530  from minimum volume to maximum volume. At angle  2 , the axial cam slot allows plunger  600  movement to provide expanding element  530  volumes ranging from maximum volume to an intermediate volume (at an intermediate stroke) that is greater than minimum volume but less than maximum volume. At angle  3 , the axial cam slot retains plunger  600  at the position of maximum volume of the expanding element  530 .  FIG. 23A  also illustrates positions A, B, C, D and E of plunger cam follower  750  within cylinder cam slot  710  during the steps of operation. 
         [0139]      FIG. 23B  illustrates pusher cam slot  720  and retractor cam slot  730  cut into the pusher assembly of  FIG. 22C .  FIG. 23B  also illustrates positions A, B, C, D and E of plunger cam follower  750  within pusher cam slot  720  and retractor cam follower  760  within retractor cam slot  730  during the steps of operation.  FIG. 23C  illustrates angles  1  to  6  for cylinder  562  and the pusher assembly. For purposes of description, the value of the angles increases from  1  to  6 . Pusher cam slot  720  includes angles  1  and  3 , which may correspond with angles  1  and  3  of cylinder  562  (see  FIG. 23A ). Pusher cam slot  720  includes angle  4 , which is larger than  3 . The axial length of pusher cam slot  720  from position A to position B corresponds to the maximum stroke of the plunger  600 , as described above. The axial length of pusher cam slot  720  from position C to position E corresponds to the intermediate stroke (as described above) plus the axial distance traversed by retractor cam follower  760  from position C to position E in retractor cam slot  730 . Retractor cam slot  730  includes angles  5  and  6 . Positions A and B at angle  5  prevent compression spring  540  from displacing cylinder  562  within the pusher assembly. 
         [0140]    In operation, retractor cam slot  730  controls the motion of cylinder  562  within the pusher assembly. As shown in  FIG. 23A  and  FIG. 23B , when plunger cam follower  750  (of sequencing bolt  600 ) is moved circumferentially from position B to position C in both cylinder cam slot  710  and pusher cam slot  720 , retractor earn follower  760  is forced from position B to position C in retractor cam slot  730 , which allows compression spring  540  (see  FIG. 19 ) to push cylinder  562  axially within the pusher assembly. Retractor cam follower  760  within retractor cam slot  730  holds cylinder  562  at a constant angular position relative to the pusher assembly during movement from position C to positions D and E; therefore, movement of plunger cam follower  750  from position C to position D within pusher cam slot  720  forces cam follower  750  into the axial slot corresponding to angle  2  of cylinder  562 . 
         [0141]    Referring to  FIGS. 24A to 24E , the applicator of the present invention is shown at various steps during use. Note that these figures do not include details of the locking means to securely hold the connector conduit  100 .  FIG. 24A  to  FIG. 24E  correspond to positions A to E, respectively, which are described in  FIG. 23A  to  FIG. 23C . Recognizing that individual surgeons may find alternative steps to properly use the invention, a representative sequence of steps for use of the applicator to implant a connector conduit is described. These steps include first preparing the applicator with the connector conduit. With the retractor assembly in the fully extended position as shown in  FIG. 24A , a mounting and folding tool  900  is positioned into the coring element  210 , as shown in  FIG. 20 . The connector conduit  100  of  FIG. 15  is then loaded into the applicator by sliding connector conduit  100  over the folding tool  900  until sewing flange  170  contacts notch  421  (see  FIG. 18 ). The connector conduit is then locked into place using the locking means. Tool  900  is then removed. A catheter is attached to purge/fill valve  630  and to a reservoir of saline. Valve  630  is opened. Sequencing bolt  600  is then moved back and forth from position A to position B several times to purge the fluid system of air and to fill the system with fluid, such as saline. Once the air is purged, sequencing bolt  600  is placed at position A, and tool  900  is again positioned into the coring element  210 —this time to squeeze fluid from the balloon and to fold the balloon. When tool  900  is in place, valve  630  is closed, and the catheter is removed. Tool  900  is removed. The applicator with connector conduit is now ready for use, as shown in  FIG. 24A . 
         [0142]    Before implanting the connector conduit  100  into the ventricle wall, the portion of the prosthesis that includes the prosthetic valve or ventricular assist device, as examples, is connected to the aorta. This portion of the prosthesis also includes the female end of quick connect coupler  180 . By implanting this portion of the prosthesis first, the time between insulting the heart by cutting a hole and beginning blood flow through the complete prosthesis is minimized. 
         [0143]    A template with similar dimensions as connector conduit  100  is placed on the apex of the heart, and a marker is used to trace the circular outline of the connector onto the apex, in the planned location of insertion. Multiple (8 to 12) large pledgeted sutures (mattress sutures) of for example, 2-0 prolene, are placed in the apex surrounding the marked circle. With the connector conduit  100  loaded in the applicator of  FIG. 24A , the sutures are brought through sewing flange  170  of the connector conduit  100 . A knife is used to make a stab wound in the apex at the center of the circle. With the applicator in the position shown in  FIG. 24A , blunt tip  510  of retractor element  500  is inserted into the stab wound and pushed through the apex into the left ventricle chamber until stopper disk  515  contacts the epicardium (outside surface of the heart). Sequencing bolt  600  is moved from position A to position B to inflate the balloon behind tissue T of the heart wall (see  FIG. 24B ). The surgeon moves sequencing bolt  600  from position B to position C (see  FIG. 24C ) and then releases sequencing bolt  650 . Beginning at position C of  FIG. 24C , compression spring  540  pushes the retractor assembly from position C to position D (see  FIG. 24D ). When the retractor assembly moves from position C to position D, tissue T of the heart wall is first sandwiched between the balloon and the sharpened edge of the coring element  210   a . By the surgeon using handle  310  to apply axial force and back-and-forth rotary motion, the sharpened edge of the coring element  210   a  cuts though the heart wall to form a plug of tissue T that resides in the coring element  210 . At position D, the retractor assembly has been retracted until the balloon is in contact with coring element  210  and the tissue plug is fully within coring element  210 . Also at position D, cylinder cam slot  710  has forced plunger cam follower  750  circumferentially to angle  2 , thereby allowing deflation of the balloon to begin. Between position D ( FIG. 24D ) and position E ( FIG. 24E ), the balloon deflates to the intermediate volume (described earlier), and the retractor assembly retracts to its final position. If necessary, the surgeon may pull sequencing bolt  600  to its final position E. 
         [0144]    Connector conduit  100  is now fully implanted. The sutures are tied, and hemostasis is checked. Additional sutures may be placed if needed. The locking means (not shown) holding the connector conduit in the applicator is released, and the applicator is partially removed to a position where a clamp can be placed directly on collapsible graft  160   a  to prevent blood flow through the conduit  160 . Once the clamp is in place, the applicator may be completely removed from connector conduit  100 . The male and female ends of quick connect coupler  180  may now be connected. Umbilical tape  187  may be tied around graft extension  186   a  to reduce any blood leakage, and stay sutures may be used to secure graft extension  186   a  to outer fabric  165 . Once the flow passage of the prosthesis is purged of air, the clamp may be released to allow blood flow through the prosthesis. Flexible bend  140  is formed by pulling threads  143  and tying a knot. The connector conduit  100  is now fully implanted. 
         [0145]    As illustrated in  FIG. 27 , an alternative embodiment, can use a connector conduit having and integral hole forming element. Hole forming element  21 ′ is integrally formed, i.e. formed as a single component, with respect to connector conduit  100 ′. Connector conduit  100 ′ can be loaded on an applicator (not having a separate hole forming element) in a manner similar to that disclosed above. After forming the hole and inserting the connector conduit into the hole, hole forming element  210 ′ can be withdrawn into a distal end of connector conduit  100 ′, as illustrated in  FIG. 26 , to reduce the possibility of unintended tissue damage. Such withdrawal can be accomplished by the sequencing means, a manual mechanism on the applicator, or with a separate instrument. 
         [0146]    In the preferred embodiment described above, the expansion element is a balloon. However, an alternative expansion element, in the form of an umbrella mechanism, is illustrated in  FIGS. 27A-27D . Retractor  500 ′ includes cylinder  810  (shown in cross section), and piston element  820  slideably disposed in cylinder  810 . Bolt  650  having follower  750  is formed on cylinder  810 . Shaft  830  extends from piston element  820  and has umbrella mechanism  850  formed on an end thereof. Umbrella mechanism  85  included plural bendable leaf elements  852  that are fixed to shaft  830  at the end of shaft  830 . Leaf elements  852  are fixed to ring  854  at the other end thereof. Ring  854  is slideably disposed on shaft  830 . Accordingly, movement of shaft  830  to the right in the FIGS. causes ring  854  to be pushed toward the end of shaft  830  as ring  854  abuts an end of cylinder  810 , as shown in  FIG. 27  D. Slot  710  guides follower  750 , ad bolt  650  cooperates with remaining elements in the sequencing mechanism in the manner described above, to coordinate the expansion state of expansion element  850 . 
         [0147]    Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. It is preferred therefore, that the present invention be limited not by the specific disclosure herein, but only by the appended claims.

Technology Category: 1