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`PROVISIONAL APPLICATION FOR PATENT COVER SHEET
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`This is a request for filing a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53(c).
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`
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`t. -:·
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`Given Name (first and middle Pf any))
`
`Family Name or Surname
`
`Giovanni
`
`Speziali
`
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`(City and either State or Foreign Country)
`Rochester Minnesota
`
`INVENTOR(S)
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`TITLE OF THE INVENTION (500 characters max)
`THORASCOPIC HEART VALVE REPAIR METHOD AND APPARATUS
`
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`5685822
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 1 of 23
`
`

`
`Client Ref.: _----=..:M=M:..:..V:::....-...:0=3--"0'-'-7=2-
`
`Q&B File: --=63=0=6=6=6c:..:.0=0=0_,_7 4..,__
`
`PATENT APPLICATION FOR
`
`THORASCOPIC HEART VALVE REPAIR METHOD AND APPARATUS
`
`By
`
`Giovanni Speziali
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 2 of 23
`
`

`
`MMV-03-072
`
`THORASCOPIC HEART VALVE REPAIR METHOD AND APPARATUS
`
`BACKGROUND OF THE INVENTION
`
`[0001]
`
`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.
`
`[0002]
`
`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.
`
`[0003]
`
`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.
`
`[0004]
`
`Of particular interest to the present invention 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.
`
`[0005]
`
`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 cornrnissures to separate
`
`-1-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 3 of 23
`
`

`
`MMV-03-072
`
`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, as described in Bodnar and Frater, Replacement Cardiac Valves 1-
`
`357 (1991), which is incorporated herein by reference. A comprehensive discussion ofheart
`
`valve diseases and the surgical treatment thereof is found in Kirklin and Barratt-Boyes,
`
`Cardiac Surgery 323-459 (1986), the complete disclosure ofwhich is incorporated herein by
`
`reference.
`
`[0006]
`
`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 an anterior position accessible through the sternotomy. An opening,
`
`or atriotomy, is then made in the right side of 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 fore mentioned techniques may
`
`then be used to repair or replace the valve.
`
`[0007]
`
`An alternative technique for mitral valve access may be used when a median
`
`sternotomy and/or rotational manipulation of the heart are 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 into 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.
`
`[0008]
`
`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
`
`-2-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 4 of 23
`
`

`
`MMV-03-072
`
`attachment within the heart. However, these invasive, open-chest procedures produce a high
`
`degre~ 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.
`
`[0009]
`
`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 tendinae, which connect the mobile
`
`valve leaflets to muscular structures (papillary muscles) inside the ventricles. Rupture or
`
`elongation of the chordae tendinae result in partial or generalized leaflet prolapse, which
`
`causes mitral (or tricuspid) valve regurgitation.
`
`[0010]
`
`The standard 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 (Fig. 1). This operation is generally
`
`carried out through a median sternotomy and requires cardiopulmonary bypass with aortic
`
`cross-clamp and cardioplegic arrest of the heart.
`
`SUMMARY OF THE INVENTION
`
`[0011]
`
`The present invention is a method and apparatus for performing thorascopic
`
`repair of heart valves while the heart is beating. More specifically the method includes
`
`inserting an instrument through the subject's chest wall and through the heart wall at the apex
`
`of the heart. The instrument carries on its distal end a gripper which is manipulated to grasp a
`
`valve leaflet and hold it while a needle mechanism punctures the valve leaflet and loops a
`
`suture around a portion of the valve leaflet. The instrument is withdrawn from the heart
`
`along with the suture and the suture is tied off at the apex of the heart after adjusting its
`
`tension for optimal valve operation as observed with an ultrasonic imaging system.
`
`[0012]
`
`In addition to a gripper and needle mechanism, the instrument includes fiber
`
`optics which provide direct visual indication that the valve leaflet is properly grasped. A set
`
`of illuminating fibers terminate at the distal end of the instrument around the needle
`
`mechanism in close proximity to a set of sensor fibers. The sensor fibers convey light from
`
`the distal end of the instrument to produce an image for the operator. When a valve leaflet is
`
`properly grasped, light from the illuminating fibers is reflected off the leaflet surface back
`
`-3-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 5 of 23
`
`

`
`MMV-03-072
`
`through the sensor fibers. On the other hand, if the valve leaflet is not properly grasped the
`
`sensor fibers see blood.
`
`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
`
`[0013]
`
`Under general anesthesia and double-lumen ventilation, the patient is prepped
`
`and draped so as to allow ample surgical access to the right lateral, anterior and left lateral
`
`chest wall (from the posterior axillary line on one side to the posterior axillary line on the
`
`other side). One or more thoracoscopic ports are inserted in the left chest through the
`
`intercostal spaces. Alternatively, a small (3-5 em) left thoracotomy is performed in the fifth
`
`or sixth intercostals space on the anterior axillary line. The patient is fully heparinized. After
`
`collapsing the left lung, the pericardium overlying the apex of the left ventricle is opened and
`
`its edges are suspended to the skin incision line. This provides close access to the apex of the
`
`heart.
`
`[0014]
`
`Guidance of the intracardiac procedure is provided by a combination of
`
`transesophageal or intravascular echocardiography with direct visualization through a fiber(cid:173)
`
`optical system built into the instrument utilized to implant the artificial chordae. A double(cid:173)
`
`pledgeted purse-string suture is placed on the apex of the left ventricle. A stab incision is
`
`made in the apex of the left ventricle and the surgical instrument is inserted, under echo
`
`guidance, into the left ventricular chamber (Fig. 2).
`
`[0015]
`
`The prolapsing segment of the mitral valve is grasped and the artificial chorda
`
`is secured to its free edge (Fig. 3). Accurate positioning of the implanted artificial chorda is
`
`guaranteed by both echo and direct fiberoptic visualization as will be described in detail
`
`below. The instrument is then withdrawn from the left ventricle chamber pulling the
`
`unattached end of the neo-implanted chorda with it. Hemostasis is achieved by tying the
`
`purse-string suture around the incision in the left ventricular apex after the instrument and
`
`chorda are withdrawn. The neo-implanted chorda is appropriately tensioned under direct
`
`echo-Doppler visualization and secured outside the apex of the heart. That is, a tension is
`
`placed on the neo-implanted chorda and the operation of the repaired valve is observed on the
`
`ultrasound image. The tension is adjusted until regurgitation is minimized.
`
`[0016]
`
`While a single chorda is implanted in the above description, additional chorda,
`
`or suture, can be implanted and attached to the apex of the heart wall with optimal tension.
`
`In this case the tensions in all the neo-implanted chorda are adjusted until optimal valve
`
`operation is achieved.
`
`-4-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 6 of 23
`
`

`
`MMV-03-072
`
`THORASCOPIC HEART VALVE REPAIR METHOD AND APPARATUS
`
`BACKGROUND OF THE INVENTION
`
`[0001]
`
`Various types of surgical procedures are currently performed to investigate,
`
`diagnose, and treat diseases of the heart and the great vessels ofthe 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.
`
`[0002]
`
`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.
`
`[0003]
`
`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.
`
`[0004]
`
`Of particular interest to the present invention 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.
`
`[0005]
`
`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
`
`-1-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 7 of 23
`
`

`
`MMV-03-072
`
`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, as described in Bodnar and Frater, Replacement Cardiac Valves 1-
`
`357 (1991 ), which is incorporated herein by reference. A comprehensive discussion of heart
`
`valve diseases and the surgical treatment thereof is found in Kirklin and Barratt-Boyes,
`
`Cardiac Surgery 323-459 (1986), the complete disclosure ofwhich is incorporated herein by
`
`reference.
`
`[0006]
`
`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 an anterior position accessible through the sternotomy. An opening,
`
`or atriotomy, is then made in the right side of 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 fore mentioned techniques may
`
`then be used to repair or replace the valve.
`
`[0007]
`
`An alternative technique for mitral valve access may be used when a median
`
`sternotomy and/or rotational manipulation of the heart are 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 into 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.
`
`[0008]
`
`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, artdlor introduction of a replacement valve through the atriotomy for
`
`-2-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 8 of 23
`
`

`
`MMV-03-072
`
`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.
`
`[0009]
`
`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 tendinae, which connect the mobile
`
`valve leaflets to muscular structures (papillary muscles) inside the ventricles. Rupture or
`
`elongation of the chordae tendinae result in partial or generalized leaflet prolapse, which
`
`causes mitral (or tricuspid) valve regurgitation.
`
`[0010]
`
`The standard 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 (Fig. 1 ). This operation is generally
`
`carried out through a median sternotomy and requires cardiopulmonary bypass with aortic
`
`cross-clamp and cardioplegic arrest of the heart.
`
`SUMMARY OF THE INVENTION
`
`[0011]
`
`The present invention is a method and apparatus for performing thorascopic
`
`repair of heart valves while the heart is beating. More specifically the method includes
`
`inserting an instrument through the subject's chest wall and through the heart wall at the apex
`
`of the heart. The instrument carries on its distal end a gripper which is manipulated to grasp a
`
`valve leaflet and hold it while a needle mechanism punctures the valve leaflet and loops a
`
`suture around a portion of the valve leaflet. The instrument is withdrawn from the heart
`
`along with the suture and the suture is tied off at the apex of the heart after adjusting its
`
`tension for optimal valve operation as observed with an ultrasonic imaging system.
`
`[0012]
`
`In addition to a gripper and needle mechanism, the instrument includes fiber
`
`optics which provide direct visual indication that the valve leaflet is properly grasped. A set
`
`of illuminating fibers terminate at the distal end ofthe instrument around the needle
`
`mechanism in close proximity to a set of sensor fibers. The sensor fibers convey light from
`
`the distal end of the instrument to produce an image for the operator. When a valve leaflet is
`
`properly grasped, light from the illuminating fibers is reflected off the leaflet surface back
`
`-3-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 9 of 23
`
`

`
`MMV-03-072
`
`through the sensor fibers. On the other hand, if the valve leaflet is not properly grasped the
`
`sensor fibers see blood.
`
`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
`
`[0013]
`
`Under general anesthesia and double-lumen ventilation, the patient is prepped
`
`and draped so as to allow ample surgical access to the right lateral, anterior and left lateral
`
`chest wall (from the posterior axillary line on one side to the posterior axillary line on the
`
`other side). One or more thoracoscopic ports are inserted in the left chest through the
`
`intercostal spaces. Alternatively, a small (3-5 em) left thoracotomy is performed in the fifth
`
`or sixth intercostals space on the anterior axillary line. The patient is fully heparinized. After
`
`collapsing the left lung, the pericardium overlying the apex of the left ventricle is opened and
`
`its edges are suspended to the skin incision line. This provides close access to the apex of the
`
`heart.
`
`[0014]
`
`Guidance of the intracardiac procedure is provided by a combination of
`
`transesophageal or intravascular echocardiography with direct visualization through a fiber(cid:173)
`
`optical system built into the instrument utilized to implant the artificial chordae. A double(cid:173)
`
`pledgeted purse-string suture is placed on the apex of the left ventricle. A stab incision is
`
`made in the apex of the left ventricle and the surgical instrument is inserted, under echo
`
`guidance, into the left ventricular chamber (Fig. 2).
`
`[0015]
`
`The prolapsing segment ofthe mitral valve is grasped and the artificial chorda
`
`is secured to its free edge (Fig. 3). Accurate positioning of the implanted artificial chorda is
`
`guaranteed by both echo and direct fiberoptic visualization as will be described in detail
`
`below. The instrument is then withdrawn from the left ventricle chamber pulling the
`
`unattached end of the neo-implanted chorda with it. Hemostasis is achieved by tying the
`
`purse-string suture around the incision in the left ventricular apex after the instrument and
`
`chorda are withdrawn. The neo-implanted chorda is appropriately tensioned under direct
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`echo-Doppler visualization and secured outside the apex of the heart. That is, a tension is
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`placed on the neo-implanted chorda and the operation of the repaired valve is observed on the
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`ultrasound image. The tension is adjusted until regurgitation is minimized.
`
`[0016]
`
`While a single chorda is implanted in the above description, additional chorda,
`
`or suture, can be implanted and attached to the apex of the heart wall with optimal tension.
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`In this case the tensions in all the neo-implanted chorda are adjusted until optimal valve
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`operation is achieved.
`
`-4-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 10 of 23
`
`

`
`MMV-03-072
`
`[0017]
`
`As shown in Fig. 9, the instrument used to perform the above procedure
`
`includes a rigid metal shaft 100 having a handle 120 at its extrathoracic (proximal) end which
`
`enables the instrument to be manipulated and guided into position. Actuating mechanisms
`
`for controlling the gripper and needle mechanism located at the distal end 140 of the
`
`instrument are also mounted near the handle.
`
`[0018]
`
`Located on the distal, intracardiac end of the instrument is a gripper which can
`
`be operated to hold a prolapsing valve leaflet. As shown in Fig. 5, the gripper in the preferred
`
`embodiment is a sliding tip 160 which can be closed to capture a mitral valve leaflet between
`
`it and the distal end of the instrument shaft 100. This mechanism may function through a
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`forceps-like mechanism, through strong suction (so as to hold the leaflet against the
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`instrument itself by creating a vacuum), through any kind of radial, axial, sliding, electro(cid:173)
`
`magnetically or vacuum-actuated system or any combination of the above. A needle
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`mechanism 180 also slides between a retracted position in which it is housed in the distal end
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`of the shaft and an extended position in which it extends into the sliding tip 160 when the tip
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`is closed on a captured leaflet. As a result, when the needle is extended, it punctures the
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`captured leaflet.
`
`[0019]
`
`The distal end ofthe shaft also contains a suture that is to be deployed in the
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`patient's heart. The suture is typically a 4-0 or 5-0 suture manufactured by a company such as
`
`Gore-Tex and it is a continuous loop. This suture is deployed by the operation ofthe needle
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`mechanism as described in more detail below.
`
`[0020]
`
`The shaft 100 has a size and shape suitable to be inserted into the patient's
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`chest and through the left ventricle cardiac wall and form a water-tight seal with the heart
`
`muscle. It has a circular or ellipsoidal cross-section and it houses the control links between
`
`the handle end and the intracardiac end of the instrument as well as a fiber optic visualization
`
`system described in more detail below.
`
`[0021]
`
`As shown in Figs. 6A-6D, in one preferred embodiment ofthe suture
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`deployment system the distal end of the instrument is positioned around the valve leaflet to be
`
`repaired (Fig. 6A) and then the gripper is closed to capture it. The needle is then extended
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`through the trapped leaflet into the instrument tip where it snags one end of the looped suture
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`in a notch formed on one side ofthe needle (Fig. 6b). The needle is then retracted to pull the
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`one end of the looped suture through the puncture opening in the leaflet and the leaflet is
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`released (Fig. 6C). The instrument is then withdrawn as shown in Fig. 6D to slide the other
`
`end of the looped suture toward the leaflet where it forms a half-hitch around the leaflet edge.
`
`-5-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1014
`Page 11 of 23
`
`

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`MMV-03-072
`
`[0022]
`
`Other suture deployment systems are possible where, for example, the needle
`
`penetrates through the leaflet and links up with a snap fitting device that is attached to the
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`looped suture in the instrument tip. The needle then withdraws pulling the device and looped
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`suture back through the penetration opening in the leaflet as described above.
`
`[0023]
`
`As shown in Fig. 7, four fiberoptic channels 10 extend along the length ofthe
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`instrument shaft 100 and terminate at its distal end. Each channel 10 contains at least one
`
`illuminating fiber which connects at its extrathoracic end to a white light source. Each
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`channel 10 also contains at least one sensor fiber which conveys reflected light from the distal
`
`end back to a visualization monitor connected to its extrathoracic end. In the preferred
`
`embodiment each channel 10 includes two illuminating fibers and two sensor fibers.
`
`[0024]
`
`The four fiberoptic channels are disposed around the needle lumen 12 such
`
`that when a valve leaflet is properly grasped, the valve leaflet tissue rests against the distal
`
`end of all the fibers. As shown in Fig. 8C, as a result, light is reflected off the tissue and four
`
`white circles are displayed on the visualization monitor. When tissue is not pressed against
`
`their distal ends, the visualization monitor displays the red color reflected from blood as
`
`shown in Fig. 8B. When no valve tissue is grasped, the monitor shows four red dots. When
`
`the valve tissue is grasped, the dots corresponding to the fiberoptics contacting the tissue tum
`
`white. If the monitor shows all four dots as white, it means that the "bite" on the valve tissue
`
`is optimal. If only the upper two dots tum white and the bottom dots remain red, the "bite"
`
`on the valve tissue is too shallow.
`
`[0025]
`
`In addition to the fiberoptic visualization system that insures that a valve
`
`leaflet is properly grasped, other real-time visualization systems are required to help guide the
`
`instrument to the valve leaflet. Preferably a transesophageal or intravascular color-Doppler
`
`echocardiography system is used for this purpose. As explained above, this imaging system
`
`is also used to determine the length of the neo-implanted artificial chordae in real-time by
`
`observing reduction or disappearance of regurgitation by transesophageal or intravascular
`
`color-Doppler echocardiography. The sutures are then secured outside the heart apex.
`
`Multiple sutures may be implanted until a satisfactory result is obtained. The instrument is
`
`then withdrawn from the ventricular cavity and the wall incision is repaired by either a pre(cid:173)
`
`positioned purse-string suture or by any kind of appropriate hemostatic device or technique.
`
`Emostasis is checked, appropriate chest drainage tubes are positioned and secured, and all
`
`incisions