`
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`""'"''• "•• •
`
`(43) International Publication Date
`21 July 2006 (27.07.2006)
`
`PCT
`
`IIIIIIIIIIIIIIIIIIIIIDIIIIIIIIIIIIIIInlmllllll~ 111111111111111110111111111
`(10) International PubHcation Number
`WO 2006/078694 A2
`
`(51) lnterna Hoo al P aten t ClassiJka tlon:
`
`Not classified
`
`(21) Interna tional App ti<.111ion N um ber :
`PCT!US2006/00 1699
`
`(22) International F iling Date: 19 January 2006 (19.0 1.2006)
`
`(25) F iling Langu age:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Prior ity l)a ta:
`60/645,677
`
`21 January 2005 (21.01.2005) US
`
`(71) Applicant (for all designmed States except US): MAYO
`FOUNDATrON FOR MEl)JCAL E DUCATION AND
`RESEARC H [US/US]; 200 First Street SE, Rochester,
`MN 55905 (US).
`
`(72) Inventor ; and
`(75) Inventor/Applicant (for US only): SPEZIALI, Giovanni
`[US/US]; 130 Cheval Lane NE, Rochester, MN 55906
`(US).
`
`(81) Designated Slates (unless othe1wise indicated. for every
`kind of national protection available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN,
`CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI,
`GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE,
`KG, KM, KN, KP, KR, KZ. LC, LK, LR, LS, LT, LU, LV,
`LY, MA, MD, MG, MK, MN, MW, MX, MZ, NA, NG, NI,
`NO, NZ, OM, PG. PH, PL, PT, RO, RU, SC, SD, SE, SG,
`SK, SL, SM, SY, TJ, TM, TN, TR, TI, TZ, UA, UG, US,
`UZ, VC, VN, YU, ZA, ZM, ZW.
`
`(84) Oesiguatcd States (unless otherwise indicated. for every
`kind of regional protection available): ARIPO (BW, Gll,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI,
`FR, GB, GR, liD, ill, IS, IT, LT, LU, LV, MC, NL, PL, PT,
`RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA,
`GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Published:
`without intemational search report and to be republished
`upon receipt of that report
`
`(74) Agent: SAMMONS, B arr y, E .; QUARLES & BRADY
`LLP, 4 11 East Wisconsin Avenue, Milwaukee, W1 53202
`(US).
`
`For two-feller codes and other abbreviations. refer to the "Guid(cid:173)
`ance Notes on Codes and Abbreviations" appearing at the begin(cid:173)
`ning of each regular issue oftiJe PCT Gazelle.
`
`--
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`----iiiiii ----iiiiii
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`- --------------------------------------------------------------------------------------
`== --!!!!!!!!!!!
`iiiiii ---
`-iiiiii
`iiiiii ----
`M <
`
`(54) Tille: THORASCOPIC HEART VALVE REPArR METHOD AND APPARATUS
`
`10
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`(57) Abstract: An instrument for performing thorascopic repair of heart valves includes a shaft for extending through the chest
`N cavity and into a heart chamber providing access io a valve needing repair. A movable tip on the shaft is operable to capture a valve
`0 leaflet and a needle is operable to penecrare a capture valve leaflet and draw the suture therethrough. The suture is thus fastened to the
`
`:;, valve leaflet and the instrument is withdrawn fJ·om the heart chamber transpo rting the suture outside the heart chamber. The suture
`~ is anchored to the heart wall with proper tension as determined by observing va.lve operation with an ultrasonic imaging system.
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1013
`Page 1 of 23
`
`
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`wo 2006/078694
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`PCT / US2006/00 1699
`
`THORASCOPIC HEART VALVE REPAIR METHOD AND APPARATUS
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`This application is based on U.S. Provisional Patent Application Serial
`
`No. 60/645,677 filed on January 21, 2005 and entitled ''THORASCOPIC HEART
`
`VALVE REPAIR METHOD AND APPARATUS."
`
`BACKGROUND OF THE INVENTION
`
`[0002]
`
`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 mitr.al, 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.
`
`[0003]
`
`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.
`
`[0004]
`
`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.
`
`-1-
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`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
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`Neochord, Inc. Exhibit 1013
`Page 2 of 23
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`PCT /US2006/00 1699
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`[0005]
`
`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.
`
`[0006]
`
`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, 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 of which is
`
`incorporated herein by reference.
`
`[0007]
`
`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 fore mentioned techniques may then be used to repair or replace the
`
`valve.
`
`-2-
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`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
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`Neochord, Inc. Exhibit 1013
`Page 3 of 23
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`PCT! U$2006/001699
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`[0008]
`
`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.
`
`(0009]
`
`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.
`
`[0010]
`
`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
`
`regurg itation. 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.
`
`SUMMARY OF THE INVENTION
`
`-3-
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`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
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`Neochord, Inc. Exhibit 1013
`Page 4 of 23
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`PCT /US2006/00 1699
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`[0011]
`
`The present invention is a method and apparatus for performing a
`
`minimally invasive thoracoscopic 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. The instrument carries on its distal end a
`
`movable element 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 obseNed with an ultrasonic imaging system.
`
`[0012]
`
`In addition to grasping and needle mechanisms, 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 through the sensor fibers.
`
`On the other hand, if the valve leaflet is not properly grasped the sensor fibers see
`
`blood.
`
`[0013)
`
`A general object of the invention is to provide an instrument and
`
`procedure which enables heart valves to be repaired without the need for open heart
`
`surgery. The instrument is inserted through an opening in th_e chest wall and into a
`
`heart chamber while the heart is beating. The instrument enables repair of a heart
`
`valve, after which it is withdrawn from the heart and the chest.
`
`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
`
`[0014]
`
`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). As shown in Fig. 1, one or more thoracoscopic ports
`
`are inserted in the left chest through the intercostal spaces and an instrument 10 is
`
`inserted through one of these ports into the chest cavity. 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,
`
`-4-
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`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
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`Neochord, Inc. Exhibit 1013
`Page 5 of 23
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`the pericardium overlying the apex 12 of the left ventricle 14 is opened and its edges
`
`are suspended to the skin incision line. This provides close access to the apex of
`
`the heart. Guidance of the intracardiac procedure is provided by a combination of
`
`transesophageal or intravascular echocardiography (not shown in the drawings) and
`
`with direct visualization through a fiber-optical system built into the instrument 10 as
`
`will be described in detail below. A double-pledgeted purse-string suture is placed
`
`on the apex of the left ventricle 12 and a stab incision is made at that location. The
`
`surgical instrument 10 is inserted through this incision, into the left ventricular
`
`chamber 14 of the beating heart.
`
`[0015]
`
`Referring particularly to Fig. 2, the instrument 10 may be used to grasp
`
`a prolapsing segment of the mitral valve 16 and an artificial chorda 18 may be
`
`secured to its free edge. Accurate positioning of the implanted artificial chorda 18 is
`
`guaranteed by both echo and direct fiberoptic visualization as will be described in
`
`detail below. The instrument 10 is then withdrawn from the left ventricle chamber 14
`
`pulling the unattached end of the nee-implanted chorda 18 with it. Hemostasis is
`
`achieved by tying the purse-string suture around the incision in the left ventricular
`
`apex 12 after the instrument 10 and chorda 18 are withdrawn. As shown in Fig. 3,
`
`the nee-implanted chorda 18 is appropriately tensioned under direct echo-Doppler
`
`visualization and secured outside the apex 12 of the heart. That is, a tension is
`
`placed on the nee-implanted chorda 18 and the operation of the repaired valve 16 is
`
`observed on the ultrasound image. The tension is adjusted until regurgitation is
`
`minimized.
`
`[0016]
`
`While a single chorda 18 is implanted in the above description,
`
`additional chorda, or sutures, can be implanted and attached to the apex 12 of the
`
`heart wall with optimal tension. In this case the tensions in all the nee-implanted
`
`chorda 18 are adjusted until optimal valve operation is achieved.
`
`[0017]
`
`As shown in Figs. 4 and 5, the instrument 10 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 grasping mechanism
`
`and needle mechanism located at the distal end 140 of the instrument are also
`
`mounted near the handle 120. As will be described below, the grasping mechanism
`
`-5-
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`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
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`Neochord, Inc. Exhibit 1013
`Page 6 of 23
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`PCT /U 52006/001699
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`is operated by squeezing the scissor-grip handle 120, and the needle mechanism is
`
`operated by moving an up-turned control shaft 122.
`
`[0018]
`
`Located on the distal, intracardiac end 140 of the instrument 10 is a
`
`grasping mechanism which can be operated to hold a prolapsing valve leaflet. As
`
`shown in Figs. 6 and 7, in the preferred embodiment this mechanism is a tip 160
`
`which is supported on the distal end of the shaft 100 by a set of rods 162. The rods
`
`162 slide within the shaft 1 00 to move the tip 160 between an open position as
`
`shown in Figs. 68 and 7 and a closed position as shown in Fig. 6A when the scissor(cid:173)
`
`grip handle 120 is operated. As will be explained below, a mitral valve leaflet is
`
`located in the gap between the open tip 160 and the distal end of shaft 100 and it is
`
`captured by closing the tip 160 to pinch the valve leaflet therebetween.
`
`[0019]
`
`Disposed in a needle lumen 164 formed in the shaft 100 is a needle
`
`180 which connects to the control shaft 122 at the proximal end of shaft 100.
`
`Needle mechanism 180 slides between a retracted position in which it is housed in
`
`the lumen 164 near the distal end of the shaft 100 and an extended position in which
`
`it extends into the sliding tip 160 when the tip is in its closed position. As a result, if
`
`a valve leaflet has been captured between the tip 160 and the distal end of shaft 100
`
`the needle may be extended from the lumen 164 by moving control shaft 122 to.
`
`puncture the captured leaflet and pass completely through it.
`
`[0020]
`
`The distal end of the shaft 100 also contains an artificial chorda, or
`
`suture 18 that is to be deployed in the patient's heart. The suture 18 is typically a 4-
`
`0 or 5-0 suture manufactured by a company such as Gore-Tex. This suture 18 is
`
`deployed by the operation of the grasping mechanism and the needle mechanism
`
`180 as described in more detail below.
`
`[0021]
`
`The shaft 100 has a size and shape suitable to be inserted into the
`
`patient's 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.
`
`[0022]
`
`As shown in Figs. 8A-8F, the preferred embodiment of the suture
`
`deployment system at the distal end of the instrument 10 is positioned around a
`
`valve leaflet 16 to be repaired as shown in Fig. 8A. The suture 18 is folded at the
`
`-6-
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`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
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`Neochord, Inc. Exhibit 1013
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`middle to form a loop 19 that is positioned in the tip 160. Both ends of the suture 18
`
`are disposed in a suture lumen 165 formed in the shaft 100 beneath the rods 162.
`
`As shown in Fig. 88, the valve leaflet 16 is grasped by closing the tip 160, and the
`
`needle 180 is extended to puncture the leaflet 16 and extend into the tip 160. A
`
`notch 166 formed on one side of the needle 180 hooks the suture loop 19. The
`
`needle 180 is then retracted back through the leaflet 16 to pull the suture loop 19
`
`through the puncture opening as shown in Fig. 8C. The leaflet 16 is then released
`
`and the instrument 10 is withdrawn from the heart as shown in Fig. 80 pulling both
`
`ends and the midpoint of the suture 18 with it. As shown in Fig. 8E, the suture 18 is
`
`released by the instrument 10 and the surgeon inserts the two suture ends 21
`
`through the loop 19 at its midpoint. The ends 21 are then pulled and the loop 19
`
`slides along the suture 18 back into the heart chamber 14 where it forms a Larks
`
`head around the edge of the valve leaflet as shown in Fig. 8F.
`
`[0023]
`
`Multiple sutures 18 may be implanted in this manner until a satisfactory
`
`result is obtained. After deployment of the sutures 18, the heart wall incision is
`
`repaired by either a pre-positioned purse-string suture or by any kind of appropriate
`
`hemostatic device or technique. Hemostasis is checked, appropriate chest drainage
`
`tubes are positioned and secured, and all incisions are closed.
`
`(0024]
`
`As shown in Figs. 9A-9D, a second embodiment of the suture
`
`deployment system at the distal end of the instrument 10 is positioned around a
`
`valve leaflet 16 to be repaired as shown in Fig. 9A. The suture 18 in this
`
`embodiment is a closed loop with one end of the loop disposed in the tip 160 and its
`
`other end disposed in the lumen 164 and wrapped around the needle 180. The
`
`needle 180 is extended through the grasped valve leaflet 16 into the instrument tip
`
`160 where it hooks one end of the looped suture 18 in a notch 166 formed on one
`
`side of the needle as shown in Fig. 98. The needle 180 is then retracted to pull the
`
`the looped suture 18 through the puncture opening in the leaflet 16. The leaflet is
`
`then released as shown in Fig. 9C by sliding the tip 160 to its open position. The
`
`instrument 10 is then withdrawn as shown in Fig. 90 to slide the unhooked end of
`
`the looped suture 18 along the length of the needle toward the leaflet 16 where it
`
`forms a Larks head around the leaflet edge.
`
`-7-
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`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
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`Neochord, Inc. Exhibit 1013
`Page 8 of 23
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`[0025]
`
`The instrument 10 is then withdrawing from the heart chamber 14
`
`pulling the hooked end of the suture 18 through the heart wall. The suture 18 is
`
`secured to the outside of the heart apex.
`
`[0026}
`
`As shown in Figs. 1 OA-1 00, a third embodiment of the suture
`
`deployment system at the distal end of the instrument 10 is positioned around a
`
`valve leaflet 16 to be repaired as shown in Fig. 1 OA. The midpoint 17 of the suture
`
`18 is looped around the lumen 164 and its two loose ends 20 are coiled up in the tip
`
`160. After the tip 160 is closed to capture the valve leaflet 16, the needle 180 is
`
`extended through the grasped valve leaflet 16 into the instrument tip 160. The free
`
`ends 20 of the suture 18 are positioned in the tip 160 to form a loop 19 and a notch
`
`166 formed on one side of the needle extends through this loop 19 and "hooks" the
`
`free ends of the suture 18 as shown in Fig. 108. The needle 180 is then retracted
`
`back into the lumen 164 to pull the hooked ends of the suture 18 through the
`
`puncture opening in the leaflet 16. The leaflet is then released as shown in Fig. 10C
`
`by sliding the tip 160 to its open position. The instrument 10 is then withdrawn from
`
`the heart as shown in Fig. 100 to pull the free ends 20 back through the valve leaflet
`
`16 and a Larks head is formed around the leaflet edge by the midpoint 17 of the
`
`suture 18.
`
`[0027]
`
`The instrument 10 is then withdrawn from the heart chamber 14 pulling
`
`the free ends 20 of the suture 18 through the heart wall. The free ends 20 of the
`
`suture 18 are secured to the outside of the heart apex.
`
`[0028]
`
`Other suture deployment systems are possible where, for example, the
`
`needle may penetrate through the leaflet and link up with a snap fitting device that is
`
`attached to one end of the looped suture 18 in the instrument tip 160. The needle
`
`then withdraws pulling the device and looped suture back through the penetration
`
`opening in the leaflet as described above.
`
`[0029]
`
`As shown in Fig. 7 to enhance visibility during this procedure, four
`
`fiberoptic channels 170 extend along the length of the instrument shaft 100 and
`
`terminate at its distal end. Each channel 170 contains at least one illuminating fiber
`
`which connects at its extrathoracic end to a white light source (not shown in the
`
`drawings). Each channel 170 also contains at least one sensor fiber which conveys
`
`reflected light from the distal end back to a visualization monitor (not shown in the
`
`-8-
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`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
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`Neochord, Inc. Exhibit 1013
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`drawings) connected to its extrathoracic end. In the preferred embodiment each
`
`channel 170 includes two illuminating fibers and two sensor fibers.
`
`[0030)
`
`The four fiberoptic channels 170 are disposed around the needle
`
`lumen 164 such that when a valve leaflet 16 is properly grasped, the valve leaflet
`
`tissue 16 rests against the distal end of all the fibers 170. As a result, light is
`
`reflected off the tissue back into the sensor fibers and four white circles are
`
`displayed on the visualization monitor. When the leaflet 16 is not properly pressed
`
`against the distal end of a channel 170, light is not reflected from the leaflet 16 and
`
`the visualization monitor displays the red color reflected from blood. When no valve
`
`tissue is captured, the monitor shows four red dots and when valve tissue is
`
`captured, the dots corresponding to the fiberoptic channels 170 contacting the tissue
`
`turn white. If the monitor shows all four dots as white, it means that the valve tissue
`
`capture is optimal. If only the upper two dots turn white and the bottom dots remain
`
`red, the "bite" on the valve leaflet 16 is too shallow for a proper attachment of the
`
`suture 18.
`
`[0031)
`
`In addition to the fiberoptic visualization system that insures that a
`
`valve leaflet is properly captured, other real-time visualization systems are employed
`
`to help guide the instrument 10 to the valve leaflet 16. 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
`
`nee-implanted artificial chordae in real-time by observing reduction or disappearance
`
`of regurgitation by transesophageal or intravascular color-Doppler
`
`echocardiography.
`
`-9-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1013
`Page 10 of 23
`
`
`
`WO 2006/07869-'
`
`PCT/US2006/001699
`
`CLAIMS
`
`1.
`
`a)
`
`chest cavity;
`
`A method for repairing a heart valve, the steps comprising:
`
`inserting an instrument through the subject's chest wall and into the
`
`b)
`
`inserting the distal end of the instrument through a heart wall and
`
`entering a heart chamber;
`
`c)
`
`grasping a leaflet on the heart valve with a movable device on the
`
`distal end of the instrument;
`
`d)
`
`puncturing the leaflet with a needle disposed on the distal end of the
`
`instrument and drawing a suture through the puncture to connect the suture thereto;
`
`e)
`
`f)
`
`g)
`
`anchoring the suture to another structure in the heart;
`
`withdrawing the instrument from the heart chamber; and
`
`withdrawing the instrument from the chest cavity.
`
`2.
`
`The method as recited in claim 1 in which step e) includes withdrawing
`
`the suture with the instrument from the heart chamber as recited in step f) and
`
`anchoring the suture to the outer surface of the heart wall.
`
`3.
`
`The method as recited in claim 2 in which the tension on the suture is
`
`adjusted before anchoring by observing the operation of the heart valve using a
`
`medical imaging system.
`
`4.
`
`The method as recited in claim 1 which includes placing a purse-string
`
`suture in the heart wall around the location of the instrument insertion.
`
`5.
`
`The method as recited in claim 1 in which the distal end of the
`
`instrument is inserted in step b) through the apex of the heart.
`
`6.
`
`The method as recited in claim 5 in which step e) includes withdrawing
`
`the suture with the instrument from the heart chamber as recited in step f) and
`
`anchoring the suture to the outer surface of the heart wall near the apex of the heart.
`
`-10-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1013
`Page 11 of 23
`
`
`
`WO 2006/07869-'
`
`PCT/US2006/001699
`
`7.
`
`An instrument for repairing a heart valve the combination comprising:
`
`a shaft for insertion through a chest wall and into a heart chamber;
`
`a movable element mounted on the distal end of the shaft and being operable
`
`from the extrathoracic end of the shaft to capture and hold a valve leaflet against the
`
`distal end of the shaft;
`
`a suture disposed in the distal end of the instrument; and
`
`a needle mechanism mounted on the distal end of the shaft and being
`
`operable from the extrathoracic end of the shaft to penetrate through a captured
`
`valve leaflet and draw a suture back through the penetration.
`
`8.
`
`The instrument as recited in claim 7 which includes:
`
`an illumination fiberoptic that extends through the shaft and terminates at the
`
`distal end of the shaft; and
`
`a sensor fiberoptic that extends through the shaft and terminates at the distal
`
`end of the shaft;
`
`wherein the distal ends of the fiberoptics are positioned such that light is
`
`conveyed to the valve leaflet when the valve leaflet is captured and reflected back
`
`through the sensor fiberoptic.
`
`9.
`
`The instrument as recited in claim 8 in which there are a plurality of
`
`illumination and sensor fiberoptics with their distal ends disposed around the needle
`
`mechanism.
`
`10.
`
`The instrument as recited in claim 7 in which the movable element is a
`
`tip which is slid ably mounted to the distal end of the shaft and slidable from an open
`
`position in which a space is created between the tip and the distal end of the shaft
`
`and a closed position in which the space is substantially reduced to grasp a valve
`
`leaflet therebetween.
`
`11.
`
`The instrument as recited in claim 10 in which the needle mechanism
`
`is operable to extend outward from the distal and of the shaft, through a captured
`
`valve leaflet and into the tip.
`
`-11-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1013
`Page 12 of 23
`
`
`
`wo 2006/078694
`
`PCT/US2006/00 J 699
`
`12.
`
`The instrument as recited in claim 11 in which the suture is disposed in
`
`the tip and the needle mechanism includes means for attaching to the suture when
`
`extended into the tip.
`
`13.
`
`The instrument as recited in claim 12 in which the means for attaching
`
`is a notch formed along one side of a needle that penetrates through the valve
`
`leaflet, the notch being positioned when the needle mechanism is extended into the
`
`tip to hook the suture.
`
`14.
`
`The instrument as recited in claim 11 in which the suture is disposed in
`
`the shaft with a loop formed at its midpoint extending into the tip.
`
`15.
`
`The instrument as recited in claim 14 in which the means for attaching
`
`is a notch formed along one side of a needle that penetrates through the valve
`
`leaflet, the notch being positioned when the needle mechanism is extended into the
`
`tip to hook the loop formed in the suture.
`
`16.
`
`The instrument as recited in claim 11 in which the suture is a loop and
`
`the needle mechanism includes a notch formed along one side of the needle that
`
`penetrates through the valve leaflet, the notch being positioned when the needle
`
`mechanism is extended into the tip to hook one end of the suture loop disposed
`
`therein.
`
`17.
`
`The instrument as recited in claim 16 in which another end of the
`
`suture loop wraps around the needle mechanism at a point proximal the valve
`
`leaflet.
`
`-12-
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1013
`Page 13 of 23
`
`
`
`wo 2006/07869-'
`
`FIG. 1
`
`PCTfUS2006/001699
`
`1/ 10
`
`10
`
`FlG. 2
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1013
`Page 14 of 23
`
`
`
`wo 2006!078694
`
`FIG. 3
`
`PCT!US2006!001699
`
`y--140
`
`18
`
`FIG. 4
`
`10
`~
`
`lOa
`
`12
`
`122
`
`12o...____
`
`FIG. 5
`
`162
`
`160
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1013
`Page 15 of 23
`
`
`
`wo 2006/078694
`
`PCT !US2006/00 1699
`
`3 /10
`
`100
`180
`',
`__ _ _, __ LS' .... ,
`--------- - --~
`
`FIG. 6A
`
`FIG. 68
`
`164
`
`FIG. 7
`
`165
`
`16
`
`FIG. 8A
`
`Neochord v. University of Maryland, Baltimore
`IPR2016-00208
`
`Neochord, Inc. Exhibit 1013
`Page 16 of 23
`
`
`
`wo 2006/078694
`
`PCT !US2006/00 1699
`
`4/10
`
`16
`
`180
`
`FIG. 88
`
`16
`
`I I
`It
`18
`
`FIG. 8C
`
`Neochord v. University of Maryland, Baltimore
`I