US20190133766A1 - Exchangeable System for Minimally Invasive Beating Heart Repair of Heart Valve Leaflets - Google Patents

Abstract

Improved methods and apparatuses for heart valve repair in a beating heart of a patient utilize an exchangeable heart valve repair system. Heart valve repair system can include a port adapted to be seated in the heart wall and an imaging catheter slidable within the port. The imaging catheter can be selectively locked relative to the port for insertion into the heart and unlocked once the port is seated to allow the imaging catheter to move distally towards target tissue. A deployment catheter slidably disposed in the imaging catheter and a repair cartridge slidably disposed in the deployment catheter can be used to capture the target tissue and deploy a repair device into the tissue after proper capture is confirmed. System elements can be selectively removed from and replaced within port to deploy additional repair devices while port maintains a seal while elements are and are not inserted.

Description

RELATED APPLICATION
• The present application claims the benefit of U.S. Provisional Application No. 61/428,048 filed Dec. 29, 2010, which is incorporated herein in its entirety by reference.
FIELD OF THE INVENTION
• The present invention relates to minimally invasive repair of a heart valve. More particularly, the present invention relates to minimally invasive repair of heart valves utilizing an exchangeable system that allows for multiple repair devices to be deployed with a single access into the heart that permit the repairs to be done on a beating heart without the need for cardiopulmonary bypass and open heart access to the heart.
BACKGROUND OF THE INVENTION
• Various types of surgical procedures are currently performed to investigate, diagnose, and treat diseases of the heart and the great vessels of the thorax. Such procedures include repair and replacement of mitral, aortic, and other heart valves, repair of atrial and ventricular septal defects, pulmonary thrombectomy, treatment of aneurysms, electrophysiological mapping and ablation of the myocardium, and other procedures in which interventional devices are introduced into the interior of the heart or a great vessel.
• Using current techniques, many of these procedures require a gross thoracotomy, usually in the form of a median sternotomy, to gain access into the patient's thoracic cavity. A saw or other cutting instrument is used to cut the sternum longitudinally, allowing two opposing halves of the anterior or ventral portion of the rib cage to be spread apart. A large opening into the thoracic cavity is thus created, through which the surgical team may directly visualize and operate upon the heart and other thoracic contents.
• Surgical intervention within the heart generally requires isolation of the heart and coronary blood vessels from the remainder of the arterial system, and arrest of cardiac function. Usually, the heart is isolated from the arterial system by introducing an external aortic cross-clamp through a sternotomy and applying it to the aorta between the brachiocephalic artery and the coronary ostia. Cardioplegic fluid is then injected into the coronary arteries, either directly into the coronary ostia or through a puncture in the aortic root, so as to arrest cardiac function. In some cases, cardioplegic fluid is injected into the coronary sinus for retrograde perfusion of the myocardium. The patient is placed on cardiopulmonary bypass to maintain peripheral circulation of oxygenated blood.
• Of particular interest are intracardiac procedures for surgical treatment of heart valves, especially the mitral and aortic valves. According to recent estimates, more than 79,000 patients are diagnosed with aortic and mitral valve disease in U.S. hospitals each year. More than 49,000 mitral valve or aortic valve replacement procedures are performed annually in the U.S., along with a significant number of heart valve repair procedures.
• Various surgical techniques may be used to repair a diseased or damaged valve, including annuloplasty (contracting the valve annulus), quadrangular resection (narrowing the valve leaflets), commissurotomy (cutting the valve commissures to separate the valve leaflets), shortening mitral or tricuspid valve chordae tendonae, reattachment of severed mitral or tricuspid valve chordae tendonae or papillary muscle tissue, and decalcification of valve and annulus tissue. Alternatively, the valve may be replaced by excising the valve leaflets of the natural valve and securing a replacement valve in the valve position, usually by suturing the replacement valve to the natural valve annulus. Various types of replacement valves are in current use, including mechanical and biological prostheses, homografts, and allografts.
• The mitral valve, located between the left atrium and left ventricle of the heart, is most easily reached through the wall of the left atrium, which normally resides on the posterior side of the heart, opposite the side of the heart that is exposed by a median sternotomy. Therefore, to access the mitral valve via a sternotomy, the heart is rotated to bring the left atrium into a position accessible through the sternotomy. An opening, or atriotomy, is then made in the left atrium, anterior to the right pulmonary veins. The atriotomy is retracted by means of sutures or a retraction device, exposing the mitral valve directly posterior to the atriotomy. One of the aforementioned techniques may then be used to repair or replace the valve.
• An alternative technique for mitral valve access may be used when a median sternotomy and/or rotational manipulation of the heart are/is undesirable. In this technique, a large incision is made in the right lateral side of the chest, usually in the region of the fifth intercostal space. One or more ribs may be removed from the patient, and other ribs near the incision are retracted outward to create a large opening onto the thoracic cavity. The left atrium is then exposed on the posterior side of the heart, and an atriotomy is formed in the wall of the left atrium, through which the mitral valve may be accessed for repair or replacement.
• The mitral and tricuspid valves inside the human heart include an orifice (annulus), two (for the mitral) or three (for the tricuspid) leaflets and a subvalvular apparatus. The subvalvular apparatus includes multiple chordae tendineae, which connect the mobile valve leaflets to muscular structures (papillary muscles) inside the ventricles. Rupture or elongation of the chordae tendineae result in partial or generalized leaflet prolapse, which causes mitral (or tricuspid) valve regurgitation. A commonly used technique to surgically correct mitral valve regurgitation is the implantation of artificial chordae (usually 4-0 or 5-0 Gore-Tex sutures) between the prolapsing segment of the valve and the papillary muscle. This operation is generally carried out through a median sternotomy and requires cardiopulmonary bypass with aortic cross-clamp and cardioplegic arrest of the heart.
• Using such open-chest techniques, the large opening provided by a median sternotomy or right thoracotomy enables the surgeon to see the mitral valve directly through the left atriotomy, and to position his or her hands within the thoracic cavity in close proximity to the exterior of the heart for manipulation of surgical instruments, removal of excised tissue, and/or introduction of a replacement valve through the atriotomy for attachment within the heart. However, these invasive open-chest procedures produce a high degree of trauma, a significant risk of complications, an extended hospital stay, and a painful recovery period for the patient. Moreover, while heart valve surgery produces beneficial results for many patients, numerous others who might benefit from such surgery are unable or unwilling to undergo the trauma and risks of current techniques.
• One alternative to open heart surgery is a robotically guided, thoracoscopically assisted cardiotomy procedure marketed under the tradename of the DaVinci® system. Instead of requiring a sternotomy, the DaVinci® system uses a minimally invasive approach guided by camera visualization and robotic techniques. Unfortunately, the DaVinci® system is not approved for mitral valve repair procedures on a beating heart. Thus, the use of the DaVinci® system for mitral valve repair still requires a cardiopulmonary bypass with aortic cross-clamp and cardioplegic arrest of the heart.
• While there are other laparoscopic and minimally invasive surgical techniques and tools that have been developed, most of these devices are not useable for the unique requirements of mitral valve repair on a beating heart. Suturing devices like the Superstich™ vascular suturing device or the Gore® suture passer are designed to permit manual placement of sutures as part of a surgical procedure, but are not designed for use on a beating heart. While certain annuloplasty techniques and instruments that can suture an annuloplasty ring as part of vascular repair or heart bypass surgery may be used in conjunction with a beating heart, these annuloplasty procedures do not involve the capture or retention of a constantly moving leaflet. Consequently, the design and use of annuloplasty techniques and instruments are of little help in solving the problems of developing instruments and techniques for minimally invasive thoracoscopic repair of heart valves.
• Recently, a technique has been developed for minimally invasive thoracoscopic repair of heart valves while the heart is still beating. PCT Pub. No. WO 2006/078694 A2 to Speziali discloses a thoracoscopic heart valve repair method and apparatus. Instead of requiring open heart surgery on a stopped heart, the thorascopic heart valve repair methods and apparatus taught by Speziali utilize fiber optic technology in conjunction with transesophageal echocardiography (TEE) as a visualization technique during a minimally invasive surgical procedure that can be utilized on a beating heart. U.S. Publication No. 2008/0228223 to Alkhatib also discloses a similar apparatus for attaching a prosthetic tether between a leaflet of a patient's heart valve and another portion of the patient's heart to help prevent prolapse of the leaflet and/or to otherwise improve leaflet function.
• More recent versions of these techniques are disclosed in U.S. Patent Application Publication Nos. 2009/0105751 and 2009/0105729 to Zentgraf, which disclose an integrated device that can enter the heart chamber, navigate to the leaflet, capture the leaflet, confirm proper capture, and deliver a suture as part of a mitral valve regurgitation (MR) repair.
• While the Speziali and Zentgraf techniques represent a significant advance over open heart techniques and previous minimally invasive techniques for heart valve repair, it would be advantageous to further improve upon these techniques.
SUMMARY OF THE INVENTION
• Improved methods and apparatuses for heart valve repair in a beating heart of a patient utilize an exchangeable heart valve repair system. Heart valve repair system can include a port adapted to be seated in the heart wall and an imaging catheter slidable within the port. The imaging catheter can be selectively locked relative to the port for insertion into the heart and unlocked once the port is seated to allow the imaging catheter to move distally towards target tissue. A deployment catheter slidably disposed in the imaging catheter and a repair cartridge slidably disposed in the deployment catheter can be used to capture the target tissue and deploy a repair device into the tissue after proper capture is confirmed. System elements can be selectively removed from and replaced within port to deploy additional repair devices while port maintains a seal while elements are and are not inserted.
• An exchangeable system for heart valve repair includes a port adapted to span a wall of a patient's heart that includes a sealing portion that creates a seal between the interior and exterior of the heart. An imaging catheter including at least one imaging element is slidably insertable into the port. A deployment catheter carrying a deployment mechanism is slidably insertable into the imaging catheter and a repair cartridge at least partially carrying a repair device is slidably insertable into the deployment catheter. A removable locking mechanism can be selectively engaged with the system to prevent the imaging catheter from moving distally relative to the port and when not engaged the imaging catheter is free to slide distally relative to the port to access target tissue in the heart to capture the tissue with a jaw assembly. The imaging element confirms proper capture of the target tissue and the deployment catheter and repair cartridge function together to deploy a repair device into the tissue. The sealing portion prevents blood from escaping the heart through the port while allowing selection insertion and removal of the imaging catheter, deployment catheter and repair cartridge through the port while the heart of the patient is beating.
• A method includes providing a heart valve repair system and instruction for repairing target tissue of a patient's beating heart with the system. System includes a port having a sealing element, an imaging catheter slidably received in the port, a deployment catheter slidably received in the imaging catheter, a repair cartridge at least partially carrying a repair device slidably received in the deployment catheter and a locking mechanism. The locking mechanism is first engaged with the imaging catheter such that the imaging catheter cannot be moved distally relative to the port and the system is inserted into the heart in the locked configuration to position the port in the heart wall. The removable locking mechanism is then disengaged and the imaging catheter can be slid distally relative to the port towards target tissue to be repaired. The tissue is captured between the repair cartridge and at least one of the deployment catheter and imaging catheter and proper capture is confirmed with an imaging element in the imaging catheter. A repair device is then deployed into the captured target tissue with the deployment catheter and repair cartridge. The imaging catheter, deployment catheter and/or repair cartridge can then be selectively withdrawn and replaced to deploy additional repair devices as desired with the port maintaining a seal between the interior and exterior of the heart.
• The above summary of the various embodiments of the invention is not intended to describe each illustrated embodiment or every implementation of the invention. This summary represents a simplified overview of certain aspects of the invention to facilitate a basic understanding of the invention and is not intended to identify key or critical elements of the invention or delineate the scope of the invention.
BRIEF DESCRIPTION OF THE FIGURES
• The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
• FIG. 1A is a perspective view of a heart valve repair system according to an embodiment of the present invention.
• FIG. 1B is an exploded view of the heart valve repair system ofFIG. 1A.
• FIG. 1C is a partial view of the heart valve repair system ofFIG. 1A.
• FIG. 1D is a perspective view of the heart valve repair system ofFIG. 1A.
• FIG. 2A is an exploded view of a port for a heart valve repair system according to an embodiment of the present invention.
• FIG. 2B is a perspective view of a port for a heart valve repair system according to an embodiment of the present invention.
• FIG. 2C is a perspective view of a port for a heart valve repair system according to an embodiment of the present invention.
• FIG. 2D is an exploded view of a port for a heart valve repair system according to an embodiment of the present invention.
• FIG. 2E is a perspective view of a portion of the port ofFIG. 2D.
• FIG. 3 is a flowchart of steps in a method of repairing a heart valve according to an embodiment of the present invention.
• FIG. 4A is a schematic representation of a step in a method of repairing a heart valve according to an embodiment of the present invention.
• FIG. 4B is a schematic representation of a step in a method of repairing a heart valve according to an embodiment of the present invention.
• FIG. 5 is a partial side view of a heart valve repair system according to an embodiment of the present invention.
• FIG. 6 is a schematic representation of a step in a method of repairing a heart valve according to an embodiment of the present invention.
• FIG. 7 is a schematic representation of a step in a method of repairing a heart valve according to an embodiment of the present invention.
• FIG. 8 is a schematic representation of a step in a method of repairing a heart valve according to an embodiment of the present invention.
• FIG. 9 is a partial side view of a heart valve repair system according to an embodiment of the present invention.
• FIG. 10A is a partial side view of a heart valve repair system according to an embodiment of the present invention.
• FIG. 10B is a partial side view of a heart valve repair system according to an embodiment of the present invention.
• FIG. 11 is a partial perspective view of a heart valve repair system according to an embodiment of the present invention.
• FIG. 12 is a partial side view of a heart valve repair system according to an embodiment of the present invention.
• FIG. 13A is a top view of a portion of a heart valve repair system according to an embodiment of the present invention.
• FIG. 13B is a top view of the portion of a heart valve repair system ofFIG. 13A.
• FIG. 13C is a top view of the portion of a heart valve repair system ofFIG. 13A.
• FIG. 13D is a top view of the portion of a heart valve repair system ofFIG. 13A.
• FIG. 14 is a schematic representation of a portion of a heart valve repair system according to an embodiment of the present invention.
• FIG. 15 is a partial perspective view of a portion of a heart valve repair system according to an embodiment of the present invention.
• While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
DETAILED DESCRIPTION
• In the following detailed description of the present invention, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, one skilled in the art will recognize that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as to not unnecessarily obscure aspects of the present invention.
• Embodiments of the present invention define a system that provides access into a heart chamber to repair a heart valve or other tissue structure while the heart is still beating and while minimizing the loss of blood with and without the system inserted. In one embodiment, the heart chamber is accessed transapically via thoracotomy followed by a ventriculotomy. The heart apex can initially be visualized directly through the thoracotomy or can be captured with a capture funnel which expands/unfolds until generally shaped like a conical funnel used to center, hold, and isolate the heart apex for incision. In other embodiments, the apex is visualized via an Ultrasound or IVUS system or via any other non-invasive imaging technique, such as, for example, fluoroscopy or magnetic or radio-frequency tracking.
• Once access into the heart chamber is achieved, the system is navigatable via a non-invasive imaging modality. The system provides for capture of intra-cardiac tissue structure. Once captured, the system allows control to be maintained over said tissue structure. Using a device-based imaging component, the system allows confirmation of proper capture position of the system relative to the tissue structure. The system then accommodates the delivery of a repair device to said tissue structure to reduce/eliminate mitral valve regurgitation or other defect once proper position has been confirmed. Tissue structure, as used herein, can refer to any intracardiac structure that is a site for repair or anchoring, such as, for example, valve leaflets, papillary muscles or the heart wall. A repair device is any device whose function is to repair or replace a tissue structure, such as, for example, a suture.
• An exchangeable heartvalve repair system100 for accomplishing the above described procedure is depicted inFIGS. 1A-1D.System100 includes asuture cartridge102 or other repair device, adeployment catheter104, afiber optic shaft106, aport108 and alocking mechanism110. Fiberoptic shaft106 can communicate with a display (not pictured). A handle for guiding the device can be connected to a proximal end of system.
• The fiber optic shaft orimaging catheter106 comprises an elongate shaft that can contain device-based imaging, such as fiber optics or sensors. In one embodiment, fiber optics are carried withindedicated lumens112 in an outer wall114 of fiberoptic shaft106. Device based imaging can transmit an image to display that is used to confirm proper position on the tissue structure. In one embodiment, display will confirm whether there is full (proper) or partial or no (improper) tissue structure capture. Fiberoptic shaft106 also defines a lumen that allows passage of thedeployment catheter104.
• Fiberoptic shaft106, also referred to more generally as an imaging catheter, can comprise individual optical fibers, bundled, within the wall thickness114 and terminating flush at the distal tip of thecatheter106. In one embodiment, the optical fibers are evenly spaced around the circumference of theimaging catheter106. In another embodiment, theoptic fibers106 are evenly spaced around the “top” semicircular arc of thecatheter106 relative to thesuture cartridge102. Device-based imaging can include one or more of, but is not limited to, fiber optics, a scope, ICE, OCT, Opto/Acoustic, IVUS, infrared and sonar. In one embodiment,system100 does not employ a device-based imaging component.
• Thedeployment catheter104 is used to position and deploy a repair device, such as a suture, to the tissue structure, such as a valve leaflet. Thedeployment catheter104 includes ashaft116 having aproximal end118 and adistal end120 which is inserted into the lumen of thefiber optic shaft106. Thedeployment catheter104 can have an interference fit in the lumen of thefiber optic shaft106 in order to retain thecatheter104 within theshaft106 during the procedure. Alternatively, the lumen of thefiber optic shaft106 can include a rib or other structure over which thedeployment catheter104 is advanced to provide a snap fit holding thecatheter104 within theshaft106. A deployment mechanism such as a needle is slidably disposed in aneedle lumen122 extending throughdeployment catheter104 for penetrating the valve leaflet to insert a suture. Thedeployment catheter104 also includes acartridge lumen124 adapted to slidably contain thesuture cartridge102.
• Thesuture cartridge102 is loaded into thecartridge lumen124 ofdeployment catheter104 and forms a part of thedeployment catheter104.Suture cartridge102 includes ashaft126 and atip128. Thesuture cartridge102 can contain some or all of a suture or other repair device used to repair tissue. Thesuture cartridge102 anddeployment catheter104 operate together to form clamping jaws for grasping tissue such as a valve leaflet therebetween.Tip128 ofsuture cartridge102 is movable relative todeployment catheter104 by sliding thesuture cartridge102 within thecartridge lumen124 ofdeployment catheter104. Aproximally facing surface130 of thetip128 and adistally facing surface132 of thedeployment catheter104 each operate as a portion of the clamping jaws for grasping tissue therebetween. Once tissue is grasped between the jaws, the repair device can be deployed with the deployment mechanism, such as by a needle penetrating the tissue to insert a suture. Details of various embodiments relating to tissue capture and repair device deployment are disclosed in PCT Pub. No. WO 2006/078694 A2 to Speziali and U.S. Patent Application Publication Nos. 2009/0105751 and 2009/0105729 to Zentgraf, each of which is hereby incorporated by reference.
• Theport108, shown in more detail inFIG. 2A, is positioned to span the heart muscle wall and is stabilized in that position during the procedure.Port108 can include a stabilizingportion134 and a sealingportion136 and has anopening139 extending through both portions between an interior and an exterior of the heart. In some embodiments, stabilizingportion134 can include additional stabilizing structure, such asthreads137 as shown inFIG. 2B or ribs to increase stability of theport108 in the heart wall. In an embodiment depicted inFIG. 2C,port108 includes acircumferential groove133 that defines a narrowercentral portion135 around which the heart naturally constricts to provide further stability. In one embodiment,port108 can comprise a soft material to allow the heart wall to compress into/around it to provide increased stabilization.Port108 can be flexible to accommodate the insertion of pre-formed, canted shaft/tip shapes (e.g. shaped stylets) and other elements for the advancing/securing of knots (e.g. a knot pusher).Port108 eliminates the need for multiple passes of the instrument directly against the heart muscle, minimizes blood loss due to instrument leakage, and reduces push/pull forces on the heart wall. In an alternative embodiment,system100 does not employ aport108.
• Port108 can include one ormore seals138,140 in sealingportion136 to maintain hemostasis with and without an instrument inserted to allow multiple exchanges of tools in the heart chamber while minimizing blood loss. Afirst seal138 can include anopening142 designed to seal around an inserted instrument to maintain hemostasis with the instrument inserted. In one embodiment, theopening142 is oblong to accommodate a shaft of a similarly shaped instrument. In another embodiment, theopening142 is symmetrically circular to accommodate an instrument with a shaft of a matching shape. Such a configuration allows the instrument to be circumferentially rotated following insertion. Asecond seal140 can be used to maintain hemostasis when no instrument is inserted.Seals138,140 can include slits144. In addition to allowing an instrument to pass through theseals138,140, each slit144 can secure a suture or similar repair device and hold it out of the way of the procedure while also limiting risk of unintentional tension exerted onto the suture. When multiple sutures are inserted, each can be held in aslit144 to prevent tangling of the sutures with each other or on successive passes of the instrument. In one embodiment, seal140 can includesuture retention projections143 that includesuture grooves147 that can extend partially or completely throughprojections143 for enhanced suture retention. In such an embodiment, seal138 can includeapertures145 for accommodatingsuture retention projections143. Thesystem100 can therefore control and accommodate multiple deployed repair devices from interfering with the subsequent deployment of more repair devices. In one embodiment, theseals138,140 are fixed in place relative to port108. In another embodiment, theseals138,140 are free to rotate and/or move linearly within sealingportion136.
• A handle can be connected to a proximal end of thedevice100 to allow control over the device position, jaw actuation, and repair device deployment. In one embodiment, eachdeployment catheter104 and/orsuture cartridge102 includes a separate handle that is removed and exchanged when thecatheter104 orcartridge102 is removed. In another embodiment, thesystem100 includes a single handle to whichmultiple deployment catheters104 orsuture cartridges102 are exchangeable and attachable. Handle can provide for manual or automatic actuation of the deployment mechanism for the repair device.
• A display can be communicatively coupled to the system to receive the images and/or other information captured by device-based imaging. In one embodiment, a cable connects thefiber optic shaft106 and display. In another embodiment, display wirelessly communicates with thesystem100 to obtain the observed data. Display can be an integrated display of system or standard OR monitors. An integrated display can be included as part of the handle. Alternatively, display can be projected onto a location convenient for the physician (e.g. wall, head-up display, etc.). In some embodiments, display can provide, in addition to or in lieu of visual feedback, auditory or tactile feedback.
• Theremovable locking mechanism110 locks theport108 and fiber optic shaft orimaging catheter106 relative to each other, which holds thetip128 and thefiber optic shaft106 in proper position for penetration into the heart muscle. Thus, as force is exerted by the physician from a proximal end of thesystem100 into the heart wall with the distal end of thesystem100, thesuture cartridge102,deployment catheter104,fiber optic shaft106 andport108 remain stationary with respect to each other as the heart is penetrated and the device remains stiff to allow insertion into the heart. In one embodiment,removable locking mechanism110 holds the components in place via an interference fit. In another embodiment,removable locking mechanism110 utilizes a snap fit. Whenremovable locking mechanism110 is removed, as inFIG. 1D, fiber optic shaft106 (and with itdeployment catheter104 and suture cartridge102) are able to slide forwardly relative toport108 in order to access the repair site. In one embodiment,removable locking mechanism110 is rigid.
• Removable locking mechanism110 can include a projection orfin111 that aids in removal oflocking mechanism110. In one embodiment,fin111 is rigid and unitary withlocking mechanism110. Alternatively, fin11 can be retractable via, for example, a spring mechanism to reduce the profile oflocking mechanism110 when desired. In other embodiments,removable locking mechanism110 can be removable with a separate removal tool, such as a magnetic removal tool that cooperates with a magnet inlocking mechanism110 or a removal tool that is keyed to fit into and mate with a recess in locking mechanism. The length oflocking mechanism110 can be used to control a distance that theimaging catheter116 andtip128 extend from theport108 during insertion. Typically, it is desirable to minimize this distance.
• In one embodiment,tip128 ofsuture cartridge102 is provided with a tapered configuration in order to ease entrance through and dilate the opening in the heart wall. Such a configuration reduces the insertion force necessary for entrance into the heart wall and theport108. Alternatively,system100 can employ a separate trocar to penetrate the incision and seat port109, which is then removed and replaced withimaging catheter106. In one embodiment,tip128 andshaft126 ofsuture cartridge102 anddistal end120 of fiberoptic shaft106 anddeployment catheter104 extend generally straight outwardly fromsystem100 as shown inFIG. 5. In another embodiment,distal end120 has a pre-formed and permanent curve to allow access to difficult and hard to reach areas of theheart chamber14 as shown inFIG. 6.Distal end120 can also be flexible as shown inFIG. 7 to allow it to conform to the shape ofpre-formed stylets146 to guide fiberoptic shaft106 anddeployment catheter104 along a pre-defined path. In a further embodiment,distal end120 can be capable of articulating between various angular positions as shown inFIG. 8 to allow it to adapt to various insertion geometries.
• The flowchart depicted inFIG. 3 shows the steps of asurgical procedure200 utilizingexchangeable repair system100 according to an embodiment of the present invention. In preparation for the initial insertion of the system into the heart chamber, the components are assembled and removable locking mechanism locks thefiber optic shaft106 andport108 in place relative to each other atstep202. The locked assembly is then advanced as a unit penetrating into theheart10 through aheart wall12 and into aheart chamber14 atstep204 as shown inFIG. 4A. The left ventricle is accessed viaport108 to facilitate entrance of thesystem100 into the heart chamber. The lock is then removed atstep206 to allow thefiber optic shaft106 to slide relative to theport108 as needed.
• Thecartridge102 slides in adedicated lumen124 inside of thedeployment catheter104. Thedeployment catheter104 can slide in a dedicated lumen inside of thefiber optic shaft106, but can remain generally in place during the procedure due to an interference fit or other structure retaining thedeployment catheter104 in thefiber optic shaft106. Thefiber optic shaft106 slides in a dedicated lumen inside of theport108. Theport108 maintains the access into theheart chamber14 and remains seated in theheart wall12 as the other components are selectively moved relative to theport108. Atstep208, thedeployment catheter104,suture cartridge102 and fiberoptic shaft106 can be advanced to atissue structure16 to capture thetissue structure16 with the clamping jaws. Device-based imaging present in thefiber optic shaft106 is used to confirm proper tissue capture atstep210. A repair device, such as a suture, can be deployed onto the tissue at step212. Thedeployment catheter104 and/orsuture cartridge102 can then be removed and anew deployment catheter104,suture cartridge102 or other repair device can be inserted a desired number of times to deploy additional repair devices atstep214. Thedeployment catheter104 can be exchanged with or without thefiber optic shaft106. Tools having various functions and/or employing various repair devices can be used interchangeably withsystem100 by insertion into fiberoptic shaft106.
• In one embodiment, theport108 has an inner diameter of approximately 32 french, the fiber optic shaft has an outer diameter of 28 french, the deployment cather has an outer diameter of 24 french, and therepair cartridge102shaft126 has an outer diameter of 5 french. The removable locking mechanism can have a height of about 5 french.
• System100 can be utilized in conjunction with non-invasive imaging distinct from the device-based imaging for confirmation capture in order to further enhance visualization and positioning of the system inside the heart. Non-invasive imaging refers to imaging modalities that are independent of the device and are used for global navigation of the device inside the heart. In one embodiment, thesystem100 can be guided when inside the heart via TEE (Transesophageal Echo—2D and 3D). In another embodiment, thesystem100 is guided via real-time MRI. In other embodiments, thesystem100 can be guided using fluoroscopy, infrared or sonar. In an embodiment, no external non-invasive imaging is needed.
• Device-based imaging is used bysystem100 to precisely locate thedeployment catheter104 and fiber optic shaft orimaging catheter106 on the target zone of the tissue structure. Device-based imaging can be carried by a separate fiber optic shaft orindependent imaging catheter106 or be incorporated into thedeployment catheter104.
• In one embodiment, the device-based imaging is integrated into thedeployment catheter104 via a plurality ofchannels148 carrying imaging elements to the distal end of the catheter as shown inFIG. 9. Capture of the tissue structure simultaneously results in indication of proper capture. When proper capture has been achieved, the repair device can be deployed.
• In other embodiments, the device-based imaging is independent of thedeployment catheter104. One embodiment is depicted inFIGS. 10A and 10B. Thesystem100 is inserted into the heart chamber with the independent imaging catheter or fiberoptic shaft106 inserted comprising the proximal face of the clamp that is formed with thesuture cartridge102. Capture of the tissue structure simultaneously results in indication of proper capture. When proper capture has been achieved, theindependent imaging catheter106 is retracted (intermediate proximal clamp surface may be used or theouter sheath105 may be used to maintain control of the tissue structure). Thedeployment catheter104 is then inserted and the repair device can be deployed.FIG. 11 depicts an additional embodiment wherein adeployment sheath105 defines alumen124 for thesuture cartridge102 and aseparate lumen150 that can separately carry theimaging catheter106 and thedeployment catheter104 carrying the repair device.Suture cartridge102 can include anopening152 to enhance visualization throughtip128. In some embodiments, following deployment of the repair device, thedeployment catheter104 can be removed and theimaging catheter106 reinserted to visualize/confirm effectiveness of the deployed repair device. In an embodiment, the same independent imaging catheter and deployment catheter can be reused wherein said deployment catheter is reloaded with new repair devices. In a further embodiment, the deployment catheter is disposable after a single use. Each new repair device is then loaded in a new deployment catheter.
• Device-based imaging can also be linked to thedeployment catheter104 as described previously herein with reference toFIGS. 1A-1D and as further illustrated inFIG. 12. Thesystem100 enters the heart chamber with the linkedimaging catheter106 inserted comprising the proximal face of the clamp. The linkedimaging catheter106 andport108 are locked together for puncture access into the heart chamber. The system can then be unlocked allowing theimaging catheter106 to move independently in and out of theport108. Capture of the tissue structure simultaneously results in indication of proper capture. When proper capture has been achieved, the repair device can be deployed. Thedeployment catheter104 can be retracted leaving the linkedimaging catheter106 in place. The linkedimaging catheter106 anddeployment catheter104 can also be removed together as one. Multiple repair devices can be deployed in this manner with theport108 maintaining a seal and allowing different repair devices to be deployed. In one embodiment, thesame deployment catheter104 can be reused by being reloaded with new repair devices. In another embodiment, thedeployment catheter104 is disposable after a single use and each new repair device is loaded in anindividual deployment catheter104.
• In another embodiment of thedeployment catheter104 andcartridge102tip128, multiple sets of clamps may be used, e.g., a secondary clamp composed of a retractable/collapsible wire form can be used for gross capture of the tissue structure and a primary clamp can then be used for finer precision. The primary clamp can be positioned and repositioned as desired while the secondary clamp prevents total loss of control of the tissue structure. In another embodiment shown inFIG. 15, a single clamp can incorporate arolling mechanism180. Said mechanism can be spring loaded, or loaded in a similar fashion, such that as the clamps are opened to reposition, the rolling mechanism protrudes, keeping contact/control of the tissue structure, but allowing repositioning. As the clamps are closed, the rolling mechanism is retracted into thetip128 and does not interfere with clamp closure.
• In one embodiment shown inFIG. 14, the clamp face oftip128 and/ordeployment catheter104 is embedded withmicro-needles182 for drug delivery. The drug delivered could aid in tissue growth on/through the repair device. The drug could also alter the composition of the leaflet, such as by tightening the leaflet to reduce mitral valve regurgitation (such that the drug acts as the repair device).
• System100 can be designed to load and deploy a single repair device. Alternatively, multiple repair devices can be loaded at one time and deployed simultaneously or in series. In such an embodiment, multiple repair devices can be deployed without withdrawing thedeployment catheter104 far away from the target or out of the heart completely. In one embodiment, the deployment action of a first repair device is linked to the loading action of a second repair device. In some embodiments, multiple sutures can be used on the same leaflet. Multiple sutures on both leaflets can be used and tethered together to create an edge-to-edge repair.
• The repair device delivered by the system can be a suture that is delivered through the leaflet and secured with a girth hitch knot. The suture can then be tensioned to reduce mitral valve regurgitation and anchored to the exterior of the heart apex. The suture can alternatively be anchored to the papillary muscle, to the heart wall (i.e., more lateral relative to the apex) or to a leaflet of another heart valve (e.g., a mitral valve leaflet tethered to an aortic valve leaflet). Alternatively, other securing methods can be used including alternative knots, use of a knot pusher, the creation, and advancement of the knot from the exterior of the heart, the creation/advancement of the knot while inside the heart chamber, and the use of an attachment clip.
• The suture can be captured by a deployment mechanism (e.g. a hooked needle) with a single capture area. In another embodiment, a deployment mechanism can have redundant capture points (e.g. a needle with multiple hooks or a corkscrew shape). In a further embodiment, a key and lock mechanism can be used wherein the deployment mechanism locks into a key mechanism that is connected to the suture. Alternatively, the suture is used to capture the deployment mechanism (e.g. the suture is held open in a lasso formation, the hook is passed through, the lasso is closed around the hook, and then the hook is retracted). In one embodiment, the deployment mechanism can have a retractable/collapsible capture end (e.g. the tip closes similar to an umbrella and the tip is passed by the suture in the closed position, opened, retracted to the suture, and closed around the suture).
• In some embodiments,sutures160 can be anchored with the use of apledget162 as shown inFIGS. 13A-13D.Pledgets162 typically comprise a thin soft material, such as, for example, teflon.Pledget162 defines abody164 having one or more apertures166 extending throughbody164. In one embodiment,pledget162 has threeapertures166A,166B,166C. Following deployment of thesuture160 onto a tissue structure, a firstfree end168, and a secondfree end170 of the suture can be passed through thepledget apertures166A-C. In one embodiment, free ends168,170 are passed throughpledget162 as shown inFIGS. 13A and 13B in the direction and order indicated by the arrows. Firstfree end168 ofsuture160 is threaded up throughsecond aperture166B, down throughthird aperture166C and then back up throughfirst aperture166A. Secondfree end170 is also threaded up throughsecond aperture166B and then down throughfirst aperture166A and back up throughthird aperture166C. Free ends168,170 can then be used to form aknot172 as shown inFIG. 13C. In one embodiment,pledget162 does not have apertures166 and instead suture160 is threaded through pledget with a needle or other penetrating device. Aretrieval suture174 that can be comprised of, for example, prolene, can then be threaded through thepledget162 as shown inFIG. 13D. Thepledget162 andsuture160 can be inserted into the heart chamber by using a blunt end forceps or similar instrument to pass theknot172 into the chamber approximately mid-way to the valve. Once in the chamber, theknot172 can be released and thesuture160 andpledget162 can be delivered to the tissue structure by pulling on the loop end of thesuture160. In one embodiment, multiple sutures on one or both leaflets can be tied to thesame pledget162.
• Port108 can include additional features to aid in use of apledget162 or other repair device.Port108 can include structure that moves and holds tissue structures, such as muscle, tendinae, and connective tissue, at the insertion point out of the way to ease insertion of a repair device well into the open space of the heart chamber to limit snagging of the repair device on the tissue during insertion. Alternatively,port108 can include an insertion channel that extends well into the heart chamber to allow the repair device to be inserted into the open area of the heart beyond said tissue. In addition,port108 can utilize structure to aid in retrieving and removing a repair device to limit interference with retrieval of the device back out of the heart chamber.
• Various embodiments of systems, devices and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the present invention. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, implantation locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the invention.

Claims (19)

1-27. (canceled)

28. A method of repairing a heart valve in a beating heart of a patient, comprising:

inserting a catheter into a beating heart of a patient, the catheter carrying a first suture;

grasping a valve leaflet of the heart with the catheter;

inserting the first suture through the valve leaflet and anchoring the first suture to another location in the heart; and

inserting a second suture through the valve leaflet without withdrawing the catheter from the heart and anchoring the second suture to another location in the heart.

29. The method ofclaim 28, wherein inserting a catheter into a beating heart of a patient includes inserting the catheter through a wall of the heart.

30. The method ofclaim 29, wherein inserting the catheter through a wall of the heart includes inserting the catheter through an apex of the heart.

31. The method ofclaim 29, further comprising seating a port in the wall of the heart and wherein inserting a catheter into a beating heart of a patient includes inserting the catheter through the port.

32. The method ofclaim 31, wherein the port includes a sealing element configured to create a seal around the catheter.

33. The method ofclaim 32, wherein the seal includes a plurality of slits capable of retaining sutures therein.

34. The method ofclaim 28, further comprising inserting a third suture through the valve leaflet withdrawing the catheter from the heart and anchoring the second suture to another location in the heart.

35. The method ofclaim 28, wherein the catheter is at least partially flexible.

36. The method ofclaim 28, wherein anchoring the first suture to another location in the heart and anchoring the second suture to another location in the heart includes anchoring the first suture and the second suture at locations interior to the heart.

37. The method ofclaim 28, wherein anchoring the first suture to another location in the heart and anchoring the second suture to another location in the heart includes anchoring the first suture and the second suture at locations exterior to the heart.

38. A method of repairing a heart valve in a beating heart of a patient, comprising:

seating a port comprising a flexible material in a portion of a patient's heart;

inserting a catheter into a beating heart of a patient and adjacent a valve leaflet of the heart utilizing the port, the catheter carrying a suture;

grasping the valve leaflet with the catheter; and

inserting the suture through the valve leaflet and anchoring the suture to another location in the heart.

39. The method ofclaim 38, wherein inserting a catheter into a beating heart of a patient includes inserting the catheter through a wall of the heart.

40. The method ofclaim 39, wherein inserting the catheter through a wall of the heart includes inserting the catheter through an apex of the heart.

41. The method ofclaim 38, wherein the port includes a sealing element configured to create a seal around the catheter.

42. The method ofclaim 41, wherein the seal includes a plurality of slits capable of retaining sutures therein.

43. The method ofclaim 38, wherein the catheter is at least partially flexible.

44. The method ofclaim 38, wherein anchoring the suture to another location in the heart includes anchoring the suture interior to the heart.

45. The method ofclaim 38, wherein anchoring the suture to another location in the heart includes anchoring the suture exterior to the heart.

Images