HK1189793A - Exchangeable system for minimally invasive beating heart repair of heart valve leaflets - Google Patents

Description

Replaceable system for minimally invasive repair of beating heart valve leaflets

RELATED APPLICATIONS

This application claims priority to U.S. provisional application No.61/428,048, filed on 29/12/2010, the entire contents of which are incorporated herein by reference.

Technical Field

The present invention relates to minimally invasive repair of heart valves. More particularly, the present invention relates to minimally invasive repair of heart valves using an alternative system that allows multiple repair instruments to access the heart via a single channel, which allows the repair to be completed on a beating heart without the need for cardiopulmonary bypass and opening the heart to access the heart.

Background

Currently, various types of surgical procedures are performed to study, diagnose and treat heart and thoracic great vessel diseases. These procedures include the repair and replacement of mitral, aortic and other heart valves, atrial and ventricular septal defect repair, pulmonary thrombectomy, treatment of aneurysms, electrophysiological mapping and ablation of cardiac muscle, and other procedures requiring the introduction of interventional devices into the heart or large blood vessels.

Using current techniques, many of these procedures require a total thoracotomy, usually in the form of a median sternotomy, to gain access to the patient's chest. The sternum is cut longitudinally using a saw or other cutting tool so that the two opposing anterior halves or ventral portions of the rib cage are separated. A large opening to the thoracic cavity is thus created through which the surgeon can directly view and operate on the heart and other thoracic contents.

Surgical intervention within the heart typically requires isolation of the heart and coronary vessels from the rest of the arterial system and inhibition of cardiac function. Typically, an external aortic cross clamp is introduced through a sternotomy and applied to the aorta between the brachiocephalic artery and the coronary ostia to isolate the heart from the arterial system. Cardioplegia is then injected into the coronary arteries, either directly into the coronary ostia or through a puncture in the aortic root to inhibit cardiac function. In some cases, cardioplegic solution is injected into the coronary sinus to perfuse the myocardium retrograde. The patient is subjected to cardiopulmonary bypass to maintain peripheral circulation of oxygenated blood.

Of particular note are intracardiac procedures for the surgical treatment of heart valves, particularly the mitral and aortic valves. According to recent estimates, over 79,000 patients are diagnosed with aortic and mitral valve disease annually in U.S. hospitals. Over 49,000 mitral valve or aortic valve replacement procedures are performed annually in the united states, with a large number of heart valve repair procedures.

A variety of surgical techniques can be employed to repair diseased or damaged valves, including annuloplasty (contracting the valve annulus), quadrilateral resection (narrowing the valve leaflets), commissurotomy (cutting the valve commissures to separate the valve leaflets), shortening of the mitral or tricuspid valve chordae tendineae, reattachment of broken mitral or tricuspid valve chordae tendineae or papillary muscle tissue, and decalcification of valve or annulus tissue. Alternatively, the valve may be replaced by excising the valve leaflets of the native valve and securing the replacement valve in place on the valve, typically by suturing the replacement valve to the native valve annulus. Various types of replacement valves are currently in use, including mechanical and bioprostheses, allografts, and allografts.

The mitral valve, which is located between the left atrium and left ventricle of the heart, is most easily accessible through the left atrial wall, which is usually located on the posterior side of the heart, as opposed to the side of the heart exposed by a median sternotomy. Thus, to access the mitral valve through a sternotomy, the heart needs to be inverted 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 vein. The atriotomy is contracted by sutures or a contraction instrument and the mitral valve is exposed directly behind the atriotomy. The valve is then repaired or replaced using one of the techniques mentioned above.

When a median sternotomy and/or a cardiac reversal procedure is not desired, alternative techniques for accessing the mitral valve can be employed. In this technique, a large incision is made in the right side of the rib cage, usually in the region of the fifth intercostal space. One or more ribs are removed from the patient and the other ribs near the incision are contracted outward to form a large opening in the chest cavity. The left atrium is then exposed to the posterior side of the heart, and an atriotomy is made in the left atrial wall through which the mitral valve may be accessed for repair and replacement.

Mitral and tricuspid valves in the human heart include: an orifice (annulus), two (for the mitral valve) or three (for the tricuspid valve) leaflets, and subvalvular tissue. The subvalvular tissue includes a plurality of chordae tendineae that connect the moving valve leaflets to the muscular tissue (papillary muscles) within the ventricle. Rupture or elongation of the chordae tendineae will result in partial or complete leaflet prolapse, which causes mitral (or tricuspid) valve regurgitation. A common technique for surgically correcting mitral regurgitation is to implant artificial chordae tendineae (typically 4-0 or 5-0Gore-Tex sutures) between the prolapsed segment of the valve and the papillary muscle. This procedure is usually performed by median sternotomy and requires cardiopulmonary bypass using aortic cross clamps and cardiac arrest.

With this open-chest technique, the large opening created by the median sternotomy or right thoracotomy allows the surgeon to see the mitral valve directly through the left atriotomy, and can place the hand in close proximity to the outside of the heart within the thoracic cavity to manipulate surgical instruments, remove excised tissue and/or introduce a replacement valve through the atriotomy to be affixed within the heart. However, these invasive open chest procedures create a high degree of trauma, significant risk of complications, long hospital stays, and painful recovery procedures for the patient. Moreover, while heart valve surgery works well in many patients, many other patients who might benefit from such surgery are unable or unwilling to sustain the trauma and risks associated with current techniques.

An alternative to open-heart surgery is the use of the marketed tradename Davincy (Da)The system of (1), which is a thoracoscopically assisted cardiotomy guided by a robot. The Davincy system employs a minimally invasive approach guided by camera visualization and robotics without the need for a sternotomy. Unfortunately, the darwinica system has not been approved for use in performing mitral valve repair procedures on a beating heart. Thus, mitral valve repair procedures using the darwinia system still require cardiopulmonary bypass using aortic cross clamps and cardiac arrest.

While some other laparoscopic and minimally invasive surgical techniques and instruments have been developed, most of these instruments are not capable of meeting the unique requirements for performing a beating heart mitral valve repair. Such as Supersatich^TMThe blood vessel is sutured with the instrument orSuturing apparatus for a stapler designed to allow manual replacement of a sutureAre part of the surgical procedure, but are not designed for use on a beating heart. While certain annuloplasty techniques and instruments that can suture annuloplasty rings can be used in the beating heart as part of vascular repair and heart bypass procedures, these annuloplasty procedures do not capture or hold the constantly moving leaflets. As a result, the design and use of annuloplasty techniques and instruments is of little help in addressing the problems of developing minimally invasive thoracoscopically repaired heart valves.

Recently, techniques have been developed for minimally invasive thoracoscopic heart valve repair with the heart still beating. International patent publication No. WO2006/078694A2 to Speziali discloses a thoracoscopic heart valve repair method and apparatus. The thoracoscopic heart valve repair method and apparatus taught by Speziali uses fiber optic technology in conjunction with transesophageal ultrasound (TEE) as a visualization technique in minimally invasive surgery that can be used on a beating heart, instead of requiring open-heart surgery on a heart that is stopping beating. U.S. patent application No.2008/0228223 to Alkhatib also discloses a similar device that attaches a prosthetic tether between a leaflet of a patient's heart valve and another portion of the patient's heart to prevent leaflet prolapse and/or other improvement in leaflet function.

The latest 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 ventricle, guide to the leaflets, capture the leaflets, confirm proper capture, and deliver sutures as part of a Mitral Regurgitation (MR) repair.

While the techniques of Speziali and Zentgraf represent significant advances in direct heart view techniques and previous minimally invasive techniques of heart valve repair, it would be beneficial to further improve upon these techniques.

Disclosure of Invention

Improved methods and devices for repairing a heart valve in a beating heart of a patient using a replaceable heart valve repair system. The heart valve repair system can include a port adapted to be secured in a wall of a heart and an imaging catheter slidable within the port. The imaging catheter is selectively lockable relative to the port for insertion into the heart and, once the port is secured, unlocks the imaging catheter to allow it to move distally toward the target tissue. A deployment catheter slidably disposed in the imaging catheter and a repair cartridge slidably disposed in the deployment catheter may be used to capture the target tissue and deploy the repair device into the tissue after proper capture is confirmed. The system components may be selectively removed and replaced within the port to deploy additional repair instruments, while the port remains sealed with and without insertion of the components.

An alternative system for repairing a heart valve includes a port adapted to span the wall of a patient's heart that includes a seal that forms a seal between the interior and exterior of the heart. An imaging catheter having at least one imaging element is slidably inserted into the port. A deployment catheter carrying the deployment mechanism is slidably insertable into the imaging catheter, and a repair cartridge carrying at least in part the repair instrument is slidably insertable into the deployment catheter. A removable locking mechanism is selectively engageable with the system to prevent distal movement of the imaging catheter 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 the jaw assembly. The imaging element confirms proper capture of the target tissue, and the deployment catheter and the repair cartridge act together to deploy the repair device into the tissue. The seal prevents blood from exiting the heart through the port while allowing selective insertion and removal of the imaging catheter, placement catheter, and prosthetic cartridge through the port while maintaining the patient's heart beating.

A method includes providing a heart valve repair system and instructions for repairing a target tissue of a beating heart of a patient with the system. The 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 instrument 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 move distally relative to the port, in a locked configuration the system is inserted into the heart to position the port in the heart wall. The removable locking mechanism is then unlocked and the imaging catheter can be slid distally relative to the port toward the target tissue to be repaired. Tissue is captured between the repair cartridge and at least one of the deployment catheter and the imaging catheter, proper capture being confirmed by an imaging element in the imaging catheter. The prosthetic device is then deployed into the captured target tissue using the deployment catheter and the prosthetic cartridge. The imaging catheter, deployment catheter and/or repair cartridge may then be selectively withdrawn and replaced to deploy additional repair instruments as needed, while the port remains sealed between the interior and exterior of the heart.

The above summary of various embodiments of the present invention is not intended to describe each illustrated embodiment or every implementation of the present invention. This summary is provided to facilitate a basic understanding of the invention and is not intended to identify key or critical elements of the invention or to delineate the scope of the invention.

Drawings

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 of fig. 1A.

FIG. 1C is a partial view of the heart valve repair system of FIG. 1A.

Fig. 1D is a perspective view of the heart valve repair system of fig. 1A.

Fig. 2A is an exploded view of a port for a heart valve repair system according to an embodiment of the 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 invention.

Fig. 2D is an exploded view of a port for a heart valve repair system according to an embodiment of the invention.

Fig. 2E is a perspective view of a portion of the port of fig. 2D.

FIG. 3 is a flow chart of steps in a method of repairing a heart valve according to an embodiment of the present invention.

FIG. 4A is a schematic illustration of the steps of a method of repairing a heart valve according to an embodiment of the present invention.

FIG. 4B is a schematic illustration of the steps of 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 illustration of the steps of a method of repairing a heart valve according to an embodiment of the present invention.

FIG. 7 is a schematic illustration of the steps of a method of repairing a heart valve according to an embodiment of the present invention.

FIG. 8 is a schematic illustration of the steps of 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 invention.

Fig. 10A is a partial side view of a heart valve repair system according to an embodiment of the invention.

Fig. 10B is a partial side view of a heart valve repair system according to an embodiment of the 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 invention.

Fig. 13A is a top view of a portion of a heart valve repair system according to an embodiment of the invention.

Fig. 13B is a top view of the portion of the heart valve repair system of fig. 13A.

Fig. 13C is a top view of the portion of the heart valve repair system of fig. 13A.

Fig. 13D is a top view of the portion of the heart valve repair system of fig. 13A.

FIG. 14 is a schematic view of a portion of a heart valve repair system according to an embodiment of the 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 susceptible 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, it will be recognized by one skilled in the art 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 not to unnecessarily obscure aspects of the present invention.

Embodiments of the present invention define a system that provides access to the ventricles to repair heart valves or other tissue structures while keeping the heart still beating and minimizing blood loss with and without system insertion. In one embodiment, the ventricles are accessed transapically by thoracotomy and a ventriculotomy is performed. The apex may be first visualized directly by thoracotomy, or the apex may be captured using a capture funnel that expands/unfolds until it is shaped substantially like a conical funnel for centering the apex, grasping the apex, and isolating the apex for incision. In other embodiments, the apex of the heart is visualized by ultrasound or intravascular ultrasound (IVUS) or by any other non-invasive imaging technique, such as fluoroscopy or magnetic or radio frequency tracking.

Once access to the ventricle is achieved, the system can navigate through a non-invasive imaging mode. The system provides for the capture of intracardiac tissue structures. Once captured, the system allows for maintaining control of the tissue structure. Using a device-based imaging assembly, the system allows confirmation of its correct capture position relative to the tissue structure. Once the correct location is confirmed, the system then provides space for delivery of a repair device to the tissue structure to reduce/eliminate mitral regurgitation or other defects. A tissue structure, as used herein, may refer to any intracardiac structure that is a site of repair or anchoring, such as a valve leaflet, papillary muscle, or heart wall. A prosthetic device is any device, such as a suture, that functions to repair or replace a tissue structure.

An alternative heart valve repair system 100 for performing the above-described procedure is depicted in fig. 1A-1D. The system 100 includes a suture barrel 102 or other repair instrument, a deployment catheter 104, a fiber optic rod 106, a port 108, and a locking mechanism 110. The fiber rod 106 may be in communication with a display (not shown). A handle for guiding the instrument may be coupled to the proximal end of the system.

The fiber optic rod or imaging catheter 106 comprises an extended rod that may include device-based imaging, such as fiber optics or sensors. In one embodiment, the optical fiber is carried within a specialized lumen 112 in an outer wall 114 of the fiber optic rod 106. Device-based imaging may deliver an image to a display that is used to confirm proper placement on the tissue structure. In one embodiment, the display identifies whether the tissue structure is captured in its entirety (correctly) or in part or is not (incorrectly) captured. The fiber optic rod 106 also defines a lumen that allows passage of the deployment catheter 104.

The fiber optic shaft 106, more commonly also referred to as an imaging catheter, may include individual optical fibers bundled together within the wall layer 114 and terminating flush at the distal tip of the catheter 106. In one embodiment, the optical fibers are evenly spaced along the circumference of the imaging catheter 106. In another embodiment, the optical fibers 106 are evenly spaced along the conduit 106 relative to the upper half-arc of the suture barrel 102. Device-based imaging may include, but is not limited to, one or more of fiber optics, microscopes, Image Communications Equipment (ICE), Optical Coherence Tomography (OCT), Optical/acoustic, Intravascular Ultrasound (IVUS), infrared, and sonar instruments. In one embodiment, the system 100 does not use a device-based imaging component.

Deployment catheter 104 is used to position and deploy a prosthetic device, such as a suture, to a tissue structure, such as a valve leaflet. Deployment catheter 104 includes a shaft 116 having a proximal end 118 and a distal end 120 that is inserted into the lumen of fiber optic shaft 106. To retain the catheter 104 within the shaft 106 during surgery, the placement catheter 104 may have an interference fit in the lumen of the fiber optic shaft 106. Alternatively, the lumen of the fiber optic rod 106 may include ribs or other structures by which the catheter 104 is positioned to advance to provide a snug fit to retain the catheter 104 within the rod 106. A deployment mechanism, such as a needle, is slidably disposed in the needle lumen 122 to penetrate the valve leaflets for insertion of sutures, with the needle lumen 122 extending through the deployment catheter 104. Deployment catheter 104 also includes a barrel lumen 124 adapted to slidably receive suture barrel 102.

The suture cartridge 102 fits into the cartridge cavity 124 of the deployment catheter 104 and forms a portion of the deployment catheter 104. The suture barrel 102 includes a shaft 126 and a tip 128. The suture cartridge 102 may contain some or all of a suture or other repair instrument for repairing tissue. The suture barrel 102 and the deployment catheter 104 operate together to form a jaw to grasp tissue, such as a valve leaflet, therebetween. By sliding the suture barrel 102 within the barrel lumen 124 in which the catheter 104 is positioned, the tip 128 of the suture barrel 102 may be moved relative to the positioning catheter 104. The proximal contact surface 130 of the tip 128 and the distal contact surface 132 of the positioning catheter 104 each operate as part of a jaw to grasp tissue therebetween. Once the tissue is grasped between the jaws, a deployment mechanism may be used to deploy the prosthetic device, such as by inserting a suture through the tissue with a needle. Details of various embodiments relating to tissue capture and repair device placement are disclosed in PCT publication No. WO2006/078694A2 to Speziali and U.S. patent application publication Nos. 2009/0105751 and 2009/0105729 to Zentgraf, which are hereby incorporated by reference.

The port 108, shown in greater detail in fig. 2A, is placed across the myocardial wall and is stabilized in this position during the procedure. The port 108 may include a stabilizer 134 and a seal 136, and have an opening 139 extending through the stabilizer and seal between the interior and exterior of the heart. In certain embodiments, the stabilizing portion 134 may include additional stabilizing structure to enhance the stability of the port 108 in the heart wall, such as threads 137 or ribs shown in fig. 2B. In the embodiment depicted in fig. 2C, the port 108 includes a circumferential groove 133 that defines a narrower central portion 135 around which the heart naturally contracts to provide further stability. In one embodiment, the port 108 may comprise a soft material to allow the heart wall to be pressed inward/around it to provide enhanced stabilization. The port 108 may be resilient to accommodate insertion of pre-fabricated, angled rod/tip profiles (e.g., shaped probes) and other elements to advance/tie-in a knot (e.g., a knot pusher). The port 108 eliminates the need for multiple passes of the instrument directly against the myocardium, minimizes blood loss due to instrument leakage, and reduces push/pull forces on the heart wall. In an alternative embodiment, the system 100 does not use the port 108.

The port 108 may include one or more seals 138, 140 in the seal 136 to maintain hemostasis with and without instrument insertion, thereby allowing multiple tool replacements in the ventricle while minimizing blood loss. The first seal 138 may include an opening 142 designed to seal around the insertion instrument to maintain hemostasis with the insertion instrument. In one embodiment, the opening 142 is oval shaped to accommodate the shaft of an instrument having a similar shape. In another embodiment, the opening 142 is symmetrically circular to accommodate instruments having a stem with a matching shape. This configuration allows the instrument to rotate circumferentially after insertion. The second seal 140 may be used to maintain hemostasis when no instrument is inserted. The seals 138, 140 may include slits 144. In addition to allowing the passage of instruments through the seals 138, 140, each slit 144 may trap a suture or similar prosthetic device and keep it from interfering with the performance of the procedure while also limiting the risk of inadvertent tension being applied to the suture. When multiple sutures are inserted, each suture may be held in the slit 144 to prevent the sutures from tangling with each other or with instruments that are passed in succession. In one embodiment, the seal 140 may include suture retention protrusions 143 to enhance suture retention, including suture slots 147 that may extend partially or fully through the protrusions 143. In such embodiments, the seal 138 may include an eyelet 145 to receive the suture retention projection 143. Thus, the system 100 can control and accommodate multiple placements of the prosthetic device without interfering with the subsequent placement of more prosthetic devices. In one embodiment, the seals 138, 140 are fixed in position relative to the port 108. In another embodiment, the seals 138, 140 are free to rotate and/or move linearly within the seal portion 136.

A handle may be coupled to the proximal end of the instrument 100 to allow control over the positioning of the instrument, the actuation of the jaws, and the placement of the prosthetic device. In one embodiment, each deployment catheter 104 and/or suture cartridge 102 includes a separate handle that is removed and replaced when the catheter 104 or cartridge 102 is removed. In another embodiment, the system 100 includes a single handle to which multiple deployment catheters 104 or suture cartridges 102 are replaceable and attachable. The handle may provide manual or automatic actuation of the placement structure of the prosthetic device.

A display may be communicatively coupled to the system to receive images and/or other information captured by the device-based imaging. In one embodiment, a cable couples the fiber optic rod 106 and the display. In another embodiment, a display is in wireless communication with the system 100 to obtain the observation data. The display may be a system integrated display or a standard display or monitor. The integrated display may be included as part of the handle. Alternatively, the display may be projected to a location convenient to the physician (e.g., on a wall, head-up display, etc.). In some embodiments, the display may provide audible or tactile feedback in addition to or in place of visual feedback.

A removable locking mechanism 110 locks the port 108 and the fiber optic rod or imaging catheter 106 relative to each other, the locking mechanism maintaining the tip 128 and fiber optic rod 106 in the correct position for penetration into the myocardium. Thus, as the force applied by the physician from the proximal end of the system 100 enters the heart wall in the distal direction of the system 100, the suture cartridge 102, deployment catheter 104, fiber optic rod 106, and port 108 remain fixed with respect to one another and the instrument remains rigid to allow insertion into the heart when penetrating the heart. In one embodiment, the removable locking mechanism 110 holds the assembly in place by an interference fit. In another embodiment, the removable locking mechanism 110 uses a snap-fit (snap-fit). When the removable locking mechanism 110 is removed, as in FIG. 1D, the fiber optic rod 106 (with the deployment catheter 104, suture barrel 102 and it) can be slid forward relative to the port 108 in order to access the repair site. In one embodiment, the removable locking mechanism 110 is rigid.

The removable locking mechanism 110 may include protrusions or fins 111 that aid in the removal of the locking mechanism 110. In one embodiment, the fins 111 are rigid and integral with the locking mechanism 110. Alternatively, the fins 111 may be retractable, such as by a spring mechanism, to reduce the profile of the locking mechanism 110 if desired. In other embodiments, the removable locking mechanism 110 is removable using a separate removal tool, such as a magnetic removal tool that mates with a magnet in the locking mechanism 110, or a removal tool that is keyed to accommodate and mate with a recess in the locking mechanism. The length of the locking mechanism 110 may be used to control the distance the imaging catheter 116 and tip 128 extend from the port 108 during insertion. Generally, it is desirable to minimize this distance.

In one embodiment, the pointed end 128 of the suture barrel 102 has a tapered configuration in order to facilitate access to the heart wall and to expand the opening in the heart wall. This configuration reduces the insertion force necessary to access the heart wall and port 108. Alternatively, the system 100 may use a separate trocar to penetrate the incision and seat the port 108, and then the trocar is removed and replaced with the imaging catheter 106. In one embodiment, the tip 128 and shaft 126 of the suture barrel 102, as well as the fiber optic shaft 106 and the distal end 120 of the deployment catheter 104, extend generally straight outward from the system 100, as shown in FIG. 5. In another embodiment, distal end 120 has a pre-formed fixed bend to allow access to difficult to reach areas of heart chamber 14, as shown in FIG. 6. The distal end 120 may also be flexible, as shown in FIG. 7, to allow it to follow a pre-defined path along which the fiber optic shaft 106 and the deployment catheter 104 are guided in accordance with the shape of the pre-fabricated probe 146. In yet another embodiment, the distal end 120 can articulate between different angular positions, as shown in fig. 8, to allow it to accommodate different insertion geometries.

The flow chart depicted in fig. 3 shows the steps of a surgical procedure 200 using an alternative repair system 100 according to an embodiment of the present invention. In preparation for the system to be first inserted into the ventricle, the assembly is assembled 202 and the fiber optic rod 106 and port 108 are locked in place relative to each other with a removable locking mechanism. The locked assembly is then advanced as a unit through the heart wall 12 into the heart 10 and into the ventricle 14, as shown in fig. 4A, at step 204. The left ventricle is accessed through port 108 to facilitate entry of system 100 into the ventricle. The lock is then released to allow the fiber rod 106 to slide relative to the port 108 as desired, at step 206.

The suture cartridge 102 slides within a specialized lumen 124 inside the deployment catheter 104. The deployment catheter 104 may slide within a specialized lumen inside the fiber optic rod 106, but the deployment catheter 104 may generally remain in place during the procedure due to an interference fit or other structure that retains the deployment catheter 104 within the fiber optic rod 106. The fiber optic rod 106 slides within a specialized lumen inside the port 108. Port 108 remains accessed to heart chamber 14 and port 108 remains positioned in heart wall 12 as other components are selectively moved relative to port 108. In step 208, the deployment catheter 104, the suture cartridge 102, and the fiber optic rod 106 may be advanced to the tissue structure 16 to capture the tissue structure 16 with the jaws. In step 210, device-based imaging present in the fiber optic rod 106 is used to confirm capture of the correct tissue. In step 212, a repair device, such as a suture, may be placed on the tissue. The deployment catheter 104 and/or suture cartridge 102 may then be removed and a new deployment catheter 104, suture cartridge 102, or other repair device inserted a desired number of times to deploy additional repair devices in step 214. The deployment catheter 104 may or may not be replaced with a fiber optic rod 106. By inserting into the fiber optic rod 106, tools having different functions and/or using different repair instruments may be interchangeably used with the system 100.

In one embodiment, the port 108 has an inner diameter of about 32 french, the fiber optic rod has an outer diameter of 28 french, the deployment catheter has an outer diameter of 24 french, and the rod 126 of the repair cartridge 102 has an outer diameter of 5 french. The removable locking mechanism may have a height of about 5 french.

To further enhance visualization and position the system inside the heart, the system 100 may be used in conjunction with non-invasive imaging as opposed to device-based imaging to confirm capture. Non-invasive imaging refers to a form of imaging that is device independent and is used for global navigation of instruments inside the heart. In one embodiment, the system 100 may be guided by TEE (Transesophageal Echo-2D and3D, Transesophageal cardiac ultrasound-2 and 3-dimensions) while inside the heart. In another embodiment, the system 100 is guided by real-time Magnetic Resonance Imaging (MRI). In other embodiments, fluoroscopy, infrared, or sonar guidance system 100 is used. In one embodiment, no external non-invasive imaging is required.

The system 100 uses device-based imaging for precisely positioning a deployment catheter 104 and a fiber optic shaft or imaging catheter 106 over a target region of a tissue structure. The device-based imaging may be carried by a separate fiber optic rod or a separate imaging catheter 106 or incorporated into the deployment catheter 104.

In one embodiment, device-based imaging is integrated into the deployment catheter 104 through the plurality of channels 148 to carry the imaging elements to the distal end of the catheter, as shown in fig. 9. Capturing the tissue structure results in an indication of correct capture. When proper capture is complete, the prosthetic device can be positioned.

In other embodiments, device-based imaging is independent of positioning catheter 104. One embodiment is depicted in fig. 10A and 10B. The system 100 is inserted into the ventricle with the inserted separate imaging catheter or fiber optic rod 106 constituting the proximal face of the clamp, which is constituted by the suture cartridge 102. The capture of tissue structures simultaneously results in an indication of correct capture. When proper capture is complete, the separate imaging catheter 106 is retracted (either an intermediate proximal clamping surface may be used or an outer sheath 105 may be used to maintain control of the tissue structure). The deployment catheter 104 is then inserted and the prosthetic device may be deployed. Fig. 11 depicts additional embodiments in which the deployment sheath 105 defines the lumen 124 of the suture cartridge 102 and a separate lumen 150, the separate lumen 150 carrying the imaging catheter 106 and the deployment catheter 104, respectively, and the deployment catheter 104 carrying the prosthetic device. The suture barrel 102 may include an opening 152 to enhance visualization through the tip 128. In some embodiments, after deployment of the repair instrument, the deployment catheter 104 may be removed and the imaging catheter 106 reinserted to visualize/confirm the effectiveness of the deployed repair instrument. In embodiments, the same separate imaging catheter and deployment catheter may be reused, wherein the deployment catheter is reloaded with a new prosthetic device. In yet another embodiment, the deployment catheter is disposed of after a single use. Each new prosthetic device is then loaded into a new deployment catheter.

Device-based imaging may also be coupled to the deployment catheter 104 as previously described herein with reference to fig. 1A-1D, and further illustrated in fig. 12. The system 100 is advanced into the ventricle and the inserted attached imaging catheter 106 constitutes the proximal face of the clamp. The attached imaging catheter 106 and port 108 are locked together for piercing access to the ventricle. The system may then be unlocked to allow the imaging catheter 106 to move independently into and out of the port 108. The capture of tissue structures simultaneously results in an indication of correct capture. When proper capture is complete, the prosthetic device can be positioned. The retractable deployment catheter 104 leaves the attached imaging catheter 106 in place. The attached imaging catheter 106 and deployment catheter 104 may also be removed as a unit. Multiple prosthetic devices may be deployed in such a manner that port 108 remains sealed and allows for the deployment of different prosthetic devices. In one embodiment, the same deployment catheter 104 may be reused by reloading with a new prosthetic device. In another embodiment, the deployment catheter 104 is disposable after a single use, with each new prosthetic device being loaded into a separate deployment catheter 104.

In another embodiment of positioning the catheter 104 and the tip 128 of the barrel 102, multiple sets of clips may be used, for example, a secondary clip constructed of a retractable/collapsible wire type may be used to roughly capture the tissue structure, and then a primary clip may be used to finely capture. The primary clip can be positioned and repositioned as desired, while the secondary clip prevents complete loss of control of the tissue structure. In another embodiment shown in fig. 15, a single clip may contain a rolling mechanism 180. The mechanism may be spring loaded or similarly loaded such that when the clip is opened for repositioning, the rolling mechanism is extended, maintaining contact/control of the tissue structure, but allowing repositioning. When the clip is closed, the rolling mechanism retracts into the tip 128 and does not interfere with clip closure.

In one embodiment shown in fig. 14, the tip 128 and/or the clamping surface of the deployment catheter 104 is embedded with microneedles 182 for delivery of the drug. The delivered drug can help the tissue grow on/through the prosthetic device. The drug can also alter the configuration of the leaflets, such as by tightening the leaflets to reduce mitral regurgitation (so that the drug acts as a prosthetic device).

The system 100 may be designed to house and position a single prosthetic device. Alternatively, multiple prosthetic devices may be loaded at one time and positioned simultaneously or sequentially. In such embodiments, multiple prosthetic devices can be deployed without retracting the deployment catheter 104 away from the target or completely outside the heart. In one embodiment, the placement of the first prosthetic device is coupled to the loading of the second prosthetic device. In some embodiments, multiple sutures may be used on the same leaflet. Multiple sutures can be used on both leaflets and tied together to create an edge-to-edge repair.

The repair device delivered by the system may be a suture that is delivered through the leaflets and tied up by the saddle straps. The suture may then be tightened to reduce mitral regurgitation and anchored to the outside of the apex. Alternatively, the suture may be anchored to the papillary muscles, the heart wall (i.e., a more transverse position relative to the apex of the heart) or the leaflets of another heart valve (e.g., the mitral valve leaflets tethered to the aortic valve leaflets). Alternatively, other methods of tying may be used, including interlocking knots, using a knot pusher, making and advancing a knot from outside the heart, making/advancing a knot inside the ventricle, and using an attachment clip.

The suture may be captured by a placement mechanism (e.g., a crochet) utilizing a single capture region. In another embodiment, the placement mechanism may have redundant capture points (e.g., the needle has multiple hooks or a spiral shape). In yet another embodiment, a keying mechanism may be used, wherein the placement mechanism locks within the keying mechanism attached to the suture. Alternatively, the suture is used to capture the deployment mechanism (e.g., the suture is held open in the form of a noose, the hook is passed through, the noose is closed around the hook, and then the hook is retracted). In one embodiment, the deployment mechanism may have a retractable/foldable capture end (e.g., a tip that closes much like an umbrella, the suture passes through the tip in the closed position, the tip opens, retracts to the suture, and then closes around the suture).

In certain embodiments, as shown in fig. 13A-13D, the suture 160 may be secured with the aid of a gauze 162. The gauze 162 typically comprises a thin, soft material, such as polytetrafluoroethylene (teflon). The pledget 162 defines a body 164 having one or more apertures 166 extending through the body 164. In one embodiment, the scrim 162 has three apertures 166A, 166B, 166C. After the suture 160 is placed over the tissue structure, the first free end 168 and the second free end 170 of the suture may be passed through the eyelets 166A-C of the gauze. In one embodiment, the free ends 168, 170 pass through the scrim 162 in the direction and order indicated by the arrows as shown in fig. 13A and 13B. First free end 168 of suture 160 passes upwardly through second eyelet 166B, downwardly through third eyelet 166C, and then back upwardly through first eyelet 166A. The second free end 170 also passes upwardly through the second eyelet 166B, then downwardly through the first eyelet 166A, and back upwardly through the third eyelet 166C. The free ends 168, 170 may then be used to form a junction 172, as shown in fig. 13C. In one embodiment, the gauze 162 does not have an eyelet 166, and instead, the suture 160 is passed through the gauze with a needle or other penetrating device. A retrieval suture 174, which may comprise, for example, polypropylene (prolene), may then be passed through gauze 162 as shown in fig. 13D. The gauze 162 and suture 160 may be inserted into the ventricle by using flat-headed forceps or similar instrument to deliver the knot 172 into the ventricle approximately mid-way from the valve. Once inside the ventricle, the knot 172 may be released by pulling on the looped ends of the suture 160, and the suture 160 and gauze 162 may be delivered to the tissue structure. In one embodiment, multiple sutures on one or both leaflets may be tied to the same pledget 162.

The port 108 may include additional features to aid in the use of a gauze 162 or other repair device. Port 108 may include moving and grasping tissue structures (such as muscle, chordae, and connective tissue) out of the way at the insertion point to facilitate good insertion of the prosthetic device into the open space of the ventricle to reduce obstruction of the prosthetic device in the tissue during insertion. Alternatively, the port 108 may include an insertion channel that extends appropriately into the ventricle to allow insertion of the prosthetic device across the tissue into the open area of the heart. In addition, the port 108 may use structure to assist in retrieving and removing the prosthetic device to reduce interference with retrieving the device from the ventricle.

Various embodiments of systems, instruments and methods have been described herein. These embodiments are given by way of example only and are not intended to limit the scope of the invention. Furthermore, it should be appreciated that different features of the described embodiments may be combined in different ways to produce many additional embodiments. In addition, while various materials, dimensions, configurations, implants, locations, etc. have been described for the disclosed embodiments, other values besides those already disclosed may be used without departing from the scope of the invention.

Claims (20)

1. A system for repairing a heart valve in a beating heart of a patient, comprising:

a port adapted to span across a wall of a heart of a patient, the port having an opening therethrough and including a seal having at least one seal, the seal being positioned within the opening between an interior and an exterior of the heart;

an imaging catheter slidably inserted into the opening of the port, the imaging catheter having at least one lumen therethrough and including at least one imaging element;

a deployment catheter slidably inserted into the lumen of the imaging catheter, the deployment catheter carrying a deployment mechanism and including at least one lumen therethrough, wherein a distal end of at least one of the imaging catheter and the deployment catheter forms a first portion of a jaw assembly for grasping a target tissue in a heart for repair;

a repair cartridge slidably inserted into the lumen of the deployment catheter, the repair cartridge at least partially carrying a repair instrument adapted to repair the target tissue, the repair instrument being deployed onto the target tissue along with the deployment mechanism, the repair cartridge having a shaft with a tip at a distal end of the shaft, wherein a proximal contact surface of the tip constitutes a second portion of the jaw assembly; and

a removable locking mechanism adapted to prevent distal movement of the imaging catheter relative to the port toward the target tissue when engaged with the imaging catheter;

wherein when the removable locking mechanism is not engaged with the imaging catheter, the imaging catheter is free to slide distally relative to the port to access the target tissue in the heart to capture the target tissue with the jaw assembly;

wherein the at least one imaging element confirms proper capture to the target tissue with the jaw assembly; and

wherein the at least one seal substantially prevents blood from exiting the heart through the port while providing selective insertion and removal of the imaging catheter, deployment catheter, and prosthetic cartridge through the port while the patient's heart is beating.

2. The system of claim 1, further comprising a second repair cartridge at least partially carrying a second repair instrument, the second repair cartridge adapted to replace the repair cartridge in the system after deployment of the repair instrument.

3. The system of claim 2, further comprising a second deployment catheter, wherein the second repair cartridge is inserted into the second deployment catheter.

4. The system of claim 1, wherein the prosthetic device is a suture.

5. The system of claim 4, further comprising a gauze to which the suture is tied after placement of the suture, the gauze adapted to be directly attached to the target tissue.

6. The system of claim 1, wherein the at least one imaging element comprises a plurality of optical fibers carried in at least one specialized lumen of the imaging catheter.

7. The system of claim 1, wherein the removable locking mechanism engages an outer surface of the imaging catheter and prevents distal movement of the imaging catheter toward the target tissue by providing a physical barrier sandwiched between a proximal surface of the port and a distal surface of a portion of the imaging catheter, the physical barrier protruding relative to the outer surface of the imaging catheter engaged by the removable locking mechanism.

8. The system of claim 1, wherein the tip of the repair cartridge has a tapered distal end.

9. The system of claim 1, wherein the sealing portion of the port includes at least a first seal having an opening adapted to seal around an outer surface of the imaging catheter and a second seal having a plurality of slits that remain substantially sealed when the imaging catheter is not inserted through the second seal.

10. The system of claim 1, wherein the port includes a stabilizer that engages and seals with the heart wall and extends into the heart to provide access to an interior of the heart through the port.

11. A system for repairing a heart valve in a beating heart of a patient, comprising:

a port adapted to span across a wall of a heart of a patient, the port having an opening therethrough between an interior and an exterior of the heart;

a catheter slidably inserted into said opening of said port, said catheter including at least one imaging element and a placement mechanism and having a distal end constituting a first portion of a jaw assembly adapted to grasp target tissue for repair in the heart;

a repair cartridge slidably inserted into the catheter, the repair cartridge at least partially carrying a repair instrument that is positioned into the target tissue along with the positioning mechanism, the repair cartridge having a shaft with a tip at a distal end of the shaft, the tip constituting a second portion of the jaw assembly, wherein the imaging element confirms proper capture of the target tissue with the jaw assembly;

a removable locking mechanism adapted to prevent the catheter from moving distally relative to the port toward the target tissue when engaged with the catheter, the catheter being free to slide distally relative to the port to access the target tissue in the heart when the removable locking mechanism is not engaged with the catheter; and

a seal disposed within the opening of the port, the seal adapted to substantially prevent blood from exiting the heart through the port while providing selective insertion and removal of the catheter and prosthetic cartridge through the port as the patient's heart beats.

12. The system of claim 11, wherein the catheter comprises an imaging catheter carrying the imaging element and a separate deployment catheter carrying the deployment mechanism.

13. The system of claim 12, wherein the deployment catheter is slidably inserted into a lumen of the imaging catheter.

14. The system of claim 12, wherein the placement catheter and imaging catheter are selectively insertable into a common lumen of the catheter.

15. The system of claim 11, further comprising a second repair cartridge at least partially carrying a second repair instrument, the second repair cartridge adapted to replace the repair cartridge in the system after deployment of the repair instrument.

16. The system of claim 11, wherein the prosthetic device is a suture.

17. The system of claim 16, further comprising a gauze to which the suture is tied after placement of the suture, the gauze adapted to be directly attached to the target tissue.

18. The system of claim 11, wherein the removable locking mechanism engages an outer surface of the catheter and prevents distal movement of the catheter toward the target tissue by providing a physical barrier sandwiched between a proximal surface of the port and a distal surface of a portion of the catheter, the physical barrier protruding relative to the outer surface of the catheter engaged by the removable locking mechanism.

19. The system of claim 11, wherein the at least one closure comprises at least a first seal having an opening adapted to seal around an outer surface of the catheter and a second seal having a plurality of slits that remain substantially sealed when the catheter is not inserted through the second seal.

20. A method of providing instrumentation and instructions to repair a valve leaflet, comprising:

providing the device of any one of claims 1-19; and

instructions are provided to operate the apparatus of claims 1-19 to repair the valve leaflet.