I|||||||||||ll|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`USUll62698l9B1
`
`(12) Umted States Patent
`02 et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 6,269,819 BI
`Aug. 7, 2001
`
`.
`
`3_.8'.-’4_.338
`4_.l}5(3.854
`4_.484_.5?‘.'}'
`
`-
`’
`_’
`:a.l?l.Z‘>2
`
`4I1fJ'.r’S King at al. .
`111197’!
`laorems er a1.
`ll,’1984 Mcno et al.
`.
`gfij?
`‘
`'
`‘
`H '
`l2;‘19)2 lrtedland .
`(List continued on next page.)
`FORDCN PATENT DOCUMLNTQ
`'
`'
`’
`'
`'
`'
`‘
`3504292
`"#1986 (DE).
`0558031
`‘H1993 (EP).
`31;-,1|42
`7511935
`(GB) .
`W0 atrnnms
`3,-'19?-II
`(W0) .
`wo 01.»'rJ1e89
`211991 (wo).
`wo 94113893
`9:199-4 (W0).
`“'0 93135638
`311993 (W0) «
`W0 99501337
`H1990 (W0)-
`we 9.<:.rrJ73a4
`2,=1.o9.o (wo).
`W0t'll'Ii"03?5‘.}
`IIIZIIIU
`Oll-IER l’UBl_lCATIONS
`
`(54) Ml'C'['H0l) AND /\I'l’ARA’I‘US FOR
`C[RCULA'[‘()RY VALVE R1.;pA[R
`
`(75)
`
`Inventors: Mohmct C. 02, Clil]'.-aids: Park, NJ
`(US); Gerald M. Le-mole. lluntingdon
`Valley‘ PA (US); Alan Lotvina Upper
`Saddle River, NJ (US); Juan P.
`Umana, New York, NY (US); William
`Allen, Stralford, CT (US); Huward I’.
`1A'ViI1.Tcam=Ck.NJ (US)
`I
`_
`_
`'
`_
`(73) Assignee: The "l‘l'ustces of Columbia University
`in the City of New York, New York,
`NY (US)
`
`( * ) Notice:
`
`Subject to any disclaimer. the term of this
`patent
`is extended or adjusted under 35
`U‘S_C‘ 154(k) by 0 days,
`
`(21) Appl.No.:
`
`091254411
`
`(22) PCI “led:
`(86) PCT No;
`
`'I“n'25’ 1998
`PCT,t'US98,-’l324[I
`.
`Feb‘ 25! 1999
`§3-‘H Dale:
`§ l(l2(e) Date: Feb. 25, 1999
`
`(37)
`
`l’(‘.Tl’ub. No; WO99f0(3059
`
`the Heart" Chapter 20 (1995) pp.
`
`Bailey, “Surgery 0]‘
`686-737-
`Abe et al., "De Vega’s annuloplasty for acquired tricuspid
`disease: Early and late results in 110 patients" Ann. 'l"h0rac.
`SW3-{1939}43157“-576«
`
`U-ii"-I ’~‘°"”“"'=d 0" "W P333‘)
`
`PCT pub Date: Jan_ 7, 1999
`
`'l‘halu.:r
`l-l.
`Prlrn(J.P_)' .";‘J_mrm'ner—Mic‘hael
`A.s:s'r'sIrrrtt I:x(um'ncr—.Iultan W. W00
`
`((30)
`
`Related U_5_ App|icmi0n nm,
`Provisional application No. 6Ui’l15l.D78, filed on Jun. 2?,
`I91
`"
`Int. (31.7 ................................................... .. A6113 l9)’00
`(51)
`(52) U.S. Cl.
`......................... .. 1213,1898; 6(}6i'142; 606.-'15?
`(58) Field of Search ................................... .. 6(l6x'}39 142
`606,143’ 151‘ 205_207’ gm’ 2]?’ 219_22I
`
`(55)
`
`Refel-enees Cited
`_
`U.S. l’A'l‘l:N'l' D()(‘.UMEN'l'S
`
`3.3T8.(|l("I
`3.5?t.9?9
`
`«H1968 Codling ct sll.
`fif1972 Moulopoulns ,
`
`.
`
`I.iut-mwitr. &
`
`l":'rm~(?uwan,
`(74) Attorrléill Agent. or
`Lalmafl. I’-C-; William 1'[- Dipper‘
`(57)
`ABSTRACT
`_
`‘
`_
`‘
`_
`An apparalus lor the rcpalr 01 :1 cardiovascular valvc having
`lcaflcls comprises 3 grasp“ Capable of grabbing and
`i-:0-apling the leallels Dlthe valve. Preferably, the grasper ha-s
`JEIW that grasp. II"I"lI'[l0l)ll1?.t.': the leaflets. and then a fastener is
`inserted to co-apt the leaflets. The apparatus is particularly
`useful for repairing mitral valves to cure mitral regurgita-
`non‘
`
`31 Claims, 13 Drawing Sheets
`
`
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`US 6,269,819 B1
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`5,226,429
`5,254,130
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`5,383.886
`5,411,558
`5,520,701
`5.536.251
`5,55-4.185
`5,618,306
`5.634_.932
`5,118,725
`5,769,812
`5,797,960
`5,823,956
`5,829,447
`5_.840_.081
`5,855,614
`5.928.224
`
`.
`
`711993 Kuzmak.
`111',-‘I993 Poncel el al.
`771994 Teilelbaum.
`.
`171995 Kcnsey et a1.
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`.
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`.
`771999 Latlfer.
`
`.
`
`.
`
`OTHER PUBLICATIONS
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`Abe el 211., "Updated: De Vega’-5 annuloplasty for acquired
`tricuspid disease: Early and late results in 110 patients” Ann.
`Thorac. Surg. (1996) 62:1876-1877.
`Alvarez et al., “Repairing the degenerative mitral valve:
`Ten—to fifteen—year
`follow—up" .1. Thorac. Cardiovasc.
`Surg. (1996) 112233-247.
`Bach et a1., "Improvement following correction of second-
`ary mitral regurgitation in end—stage cardiornyopathy with
`mitral annuloplasty" Am. J. Cardin]. (1996) 78:966-969.
`Bach et 211., “Early improvement in congestive heart failure
`after correction of secondary mitral regurgitation in end-
`stage cardiomyopathy” Am. Heart J. (1995) 12921165»-1170.
`Bolling et al., "Surgery for acquired heart disease” (1995)
`109:676-683.
`
`Dec :31 al., "Idiopathic dilated cardiomyopathy" N. Engl. J.
`Med. (1994) 331:1564—1575.
`Fucci et al., “improved results with mitral valve repair using
`new surgical techniques” Eur. J. Cardiothorac. Sug. (1995)
`9:621-627 (Merlline Record enclosed herewith.)
`Kameda el al., “Annuloplasty for severe milral regttrgilation
`due to dilated cardiomyopathy" Am. Thorac. Surg. (1996)
`6l:l829-1832.
`
`Khan et al., "Blade atrial septostomy: Experience with the
`firsl 50 procedures“ Cathel. Cardiovasc, Diagn.
`(1991)
`23:257-262.
`Maisario et al., “The edge—to—edgc technique: A simplified
`method to correct milral insuficiency” Eur. J. Cardiothorac.
`Surg. (1998). 13:240-246.
`McCarthy et al. “Tri(:uspid valve repair with the Cosgrove-
`Edwards annuloplasty system" Am. Thorac. Surg. (1997)
`64: 267-268.
`
`Park et al., “Clinical use of a blade atrial septostomy"
`Circulation (1978) 58:600-608.
`Ricchi et al. “Linear segmental anrtuloplasty for mitral valve
`repair” Ann. Thorac. Surg. (1997) 63:l805-1806.
`Tager et al., ‘‘Long—term follow—up of Rheumatic patients
`undergoing left-sided valve replacement with lrit:uspid
`annul0plasty—Validity of preoperative echocardiographic
`criteria in the decision to perform tricuspid annulopasty"
`Am. J. Cardiol. (1998) 8111013-1016.
`Uchida ct al., "Percutaneous cardiomyotomy and valvul-
`tc-niy with angioscopic guidance" Am. Heart J.
`(1991)
`121:l22l-1224.
`Umana et al., “l3ow—tie‘ mitral valve repair: An adjuvant
`technique for ischemic mitral regurgitation" Ann. Thorac.
`Surg. (1998) 66: 1640-1646.
`Umana et al., "Bow—1ie’ milral valve repair successfully
`addresses subvalvular dysfunction in isclztemic milral regur-
`gitation” (l997} Surgical Forum pp. 279-280.
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`U.S. Patent
`
`Aug. 7, 2001
`
`Sheet 1 of 13
`
`US 6,269,819 B1
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`U.S. Patent
`
`Aug. 7, 2001
`
`Sheet 2 of 13
`
`US 6,269,819 B1
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`U.S. Patent
`
`Aug. 7, 2001
`
`Sheet 3 of 13
`
`US 6,269,819 B1
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
` U.S.Patent
`
`Aug. 7, 2001
`
`Sheet 4 of 13
`
`US 6,269,819 B1
`
`NeoChord v. Univ of Ma
`
`and
`
`Exhibi
`
`O
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
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`NeoChord v. Univ of Maryland
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`Exhibit 1010
`Page 1 of 22
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`

`
`U.S. Patent
`
`Aug. 7, 2001
`
`Sheet 9 of 13
`
`US 6,269,819 B1
`
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`
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`
`eoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`U.S. Patent
`
`Aug. 7, 2001
`
`Sheet 10 of 13
`
`US 6,269,819 B1
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`U.S. Patent
`
`Aug. 7, 2001
`
`Sheet 11 of 13
`
`US 6,269,819 B1
`
`H6‘. 25
`
`I56
`
`I58
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`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`U.S. Patent
`
`Aug. 7, 2001
`
`Sheet 12 of 13
`
`US 6,269,819 B1
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`U.S. Patent
`
`Aug. 7, 2001
`
`Sheet 13 of 13
`
`US 6,269,819 B1
`
`F/6.30
`
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`
`I66
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`US 6,269,819 B1
`
`1
`METHOD AND APPARATUS FOR
`CI RCULATORY VALVE REPAIR
`
`This application is a National Phase of commonly
`assigned PCT patent application No. PC.'Ti’US98;’l3240,
`filed Jun. 25, 1998, which corresponds to US. provisional
`patent application Ser. No. 60;'fl5l,(l78, filed Jun. 27, 1997,
`now abandoned.
`
`FIELD OF THE INVENTION
`
`invention relates generally to the field of
`The present
`circulatory valve repair. More particularly,
`the present
`invention relates to the field of the repair of heart valves and
`specifically for the repair of mitral heart valves, for patients
`sulfering from mitral regurgitation.
`BACKGROUND OF TI-IE INVENTION
`
`There are four valves in the heart that serve to direct the
`llow of blood through the two sides of the heart in a fonvard
`direction. On the left side, the mitral and aortic valves direct
`oxygenated blood coming from the lungs, through the left
`side of the heart, into the aorta for distribution to the body.
`On the right side, the tricuspid valve, located between the
`right atrium and the right ventricle, and the pulmonary
`valve, located between the right ventricle and the pulmonary
`artery, direct de-oxygenated blood coming from the body,
`through the right side of the heart, into the pulmonary artery
`for distribution to the lungs. The anatomy of the heart and
`the structure and terminology of heart valves are described
`and illustrated in detail in numerous reference works on
`anatomy and cardiac surgery, including standard texts such
`as Surgery of the Chest (Sahiston and Spencer, eds., Saun-
`ders Publ., Philadelphia) and Carrtinc Surgery by Kirkljn
`and Barrett—Boyes, Pathology and Abnormalities of Heart
`Valves, incorporated herein by reference.
`All four heart valves are passive structures in that they do
`not themselves expend any energy and do not perform any
`active contractile function. They consist of moveable “leaf-
`lets” that are designed simply to open and close in response
`to differential pressures on either side of the valve. The
`mitral valve has two leaflets and the triseupid valve has
`three. The aortic and pulmonary valves are referred to as
`"semilunar valves” because of the unique appearance of
`their leaflets, which are most aptly termed “cusps" and are
`shaped somewhat like a halllrnoon. The components of the
`mitral valve assembly include the mitral valve annulus; the
`anterior leaflet; the posterior leaflet; two papillary muscles
`which are attached at their bases to the interior surface of the
`left ventricular wall; and multiple chordae tendineae, which
`couple the mitral valve leaflets to the papillary muscles.
`The problems that can develop with valves can be clas-
`sified into two categories: (1) stenosis, in which a valve does
`not open properly, or (2) insuflficiency, or regurgitation, in
`which a valve does not close properly.
`Mitral regurgitation (“MR“} is caused by dysfunction of
`the mitral subvalvular apparatus or direct injury to the valve
`leaflets. Multiple etiologies can lead to mitral regurgitation,
`with myxomatous degeneration of the valve and ischemic
`hean disease accounting for close to 60% of cases. Repair of
`the diseased valve requires major surgery on cardiopulmo-
`nary bypass to allow access to the valve. Consequently,
`some patients in the early or late stages ofthe disease are not
`considered appropriate candidates due to the high risk
`associated with the operation. Multiple studies have dem-
`onstrated that prosthetic replacement of the mitral valve can
`lead to significant postoperative left ventricular dysfunction
`
`ill
`
`15
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`0'5
`
`2
`and often requires lifelong treatment with anticoagulants.
`Mitral valve repair, using a posterior annuloplasty ring, has
`demonstrated improved results with better ventricular reoov-
`ery. Nevertheless, recent studies performed by the inventors
`(Urnana et al., Surg Forum l997} have revealed that poste-
`rior ring annuloplasty causes changes in ventricular geom-
`etry that
`lead to paradoxical movement of the normal
`papillary muscles, further deteriorating ventricular perfor-
`mance. In contrast, the “bow-tie" repair in which the anterior
`and posterior leallets of the mitral valve are fixed in oppo-
`sition appears to enhance annular contractility while pre-
`serving ventricular architecture. This has resulted in
`improved postoperative ventricular
`function almost uni-
`formly.
`The present invention addresses the needs of all patients
`with mitral regurgitation without mitral stenosis, including
`those who heretofore may have been excluded due to having
`only moderate MR or being too sick to be candidates for
`major surgery.
`The present invention linds utility not only for the repair
`of mitral valves but for all valves of the circulatory system,
`including aortic valves, trieuspicl valves, and venous valves.
`Techniques for improving the efficacy of corporeal valves
`are known. For example, Laufer et al., U.S. Pat. No. 5,609,
`598 describes a valving system for treatment of chronic
`venous insufliciency. The system has inherent limitations in
`terms of its efl’ectiveness for the procedure described and its
`applicability,
`if any,
`to other valves, especially cardiac
`valves.
`
`SUMMARY OF '1'!-IE INVENTION
`
`The present invention is directed to a method and appa-
`ratus for use in heart valve repair involving the use of an
`inserted device or grasper for grabbing and clasping together
`the anterior and posterior leaflets of the valve, by insertion
`into the left ventricle through the right chest via a
`thorascope, through the jugular vein, or through the femoral
`artery. The grasper will grab both leallets, preferably after
`the heart has been stopped or slowed phannacologically. The
`correctness of the initial grasp is assessed by, for example,
`intraoperative echocarcliography, to ensure, for example. in
`the case of the mitral valve, that the mitral regurgitation is
`resolved. If not,
`the grasper will be able to “adjust" the
`leaflets to allow better coaptation or, if needed, re—grab the
`leaflets in a different location.
`
`Either inherent to the grasper, as an integrally attached
`component or as a separate device, a fastening device is
`introduced and a fastener is deployed to securely hold the
`leaflets in place after the grasper has been released. The
`remaining portion of the device, or optionally any separate
`device, is then removed.
`Accessory devices needed for the procedure include
`instruments for thoracoscopic or percutaneous approaches.
`While the preferred method and apparatus described here-
`inbelow is discussed with reference to its use in connection
`with mitral valve repair, it is contemplated that the same or
`substantially similar apparatus and methodology would also
`be useful
`in repairing other valves found in the human
`circulatory systems, particularly other heart valves, such as,
`for example, venous valves, aortic valves and tricuspid
`valves, amongst others.
`
`OB.ll3C'I‘S OF THIS. INVENTION
`
`It is an object of the invention to provide a method for the
`repair of heart valves to increase their efficiency.
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`US 6,269,819 B1
`
`3
`is a further object of the invention to provide for a
`It
`method for
`the repair of mitral valves to reduce mitral
`regurgitation.
`It is also an object of the invention to provide for a method
`for the repair of the mitral valves which eliminates the need
`for cardiopulmonary bypass surgery.
`It is a further object of the invention to provide for an
`apparatus for percutaneous insertion into the heart to effect
`the repair of a heart valve.
`It is a yet further object ofthe invention to provide for the
`repair of a mitral valve by percutaneous insertion of a
`grasping and fastening device into the heart to repair a mitral
`valve and reduce or eliminate mitral regurgitation.
`These and other objects of the invention will become
`apparent
`to one skilled in the art from the more detailed
`description given below.
`
`BRIEF DESCRIPTION OF Tl-IE DRAWINGS
`
`FIGS. 1 to 4 are each a schematic representation of a
`portion of the human heart showing the mitral valve, the left
`ventricle and an apparatus of the invention in operation;
`FIG. Sis a schematic representation of an embodiment of
`the distal portion of an apparatus ofthe invention useful for
`grasping a mitral valve;
`FIG. 6 is a schematic representation of an embodiment of
`a distal portion of an apparatus of the invention showing a
`configuration of a fastener holder and a fastener clip in the
`open position;
`FIG. 7 is a schematic representation of an embodiment of
`FIG. 6 showing the release and closure of the fastener clip;
`FIG. 8 is a detailed, partly cross—sectional schematic
`representation of the distal end of a preferred embodiment of
`a grasper device according to the invention in the open
`position;
`FIG. 9 is a detailed, partly cross-sectional schematic
`representation of the preferred embodiment of a grasper
`device according to the invention shown in FIG. 8 in a
`closed position depicting the trartslocated adjustable grasper
`and fastener anvil within the jaws;
`FIG.
`II] is a cross—sectional representation across line
`l0—l0 of the adjustable graspcr shown in FIG. 9;
`FIG. 11 is a detailed schematic representation of a pre-
`ferred embodiment of the grasper device of the apparatus of
`the invention in the closed position with the integral closure
`means shown;
`FIG. 12 is a detailed schematic representation of the
`preferred embodiment depicted in FIG. 9 showing the clo-
`sure means piercing the Ieaflets of the valve;
`FIG. [3 is a detailed, partly cross-sectional schematic
`representation of yet another preferred embodiment of the
`distal end of a grasper device according to the invention
`showing the use of a coil closure means;
`FIGS. 14, 15, and 16 are partly cross-sectional schematic
`representations of another embodiment of the invention,
`wherein a self-closing closure is used;
`FIG. 17 is a schematic representation of the self-scaling
`closure;
`FIGS. 18 and 19 are schematic representations of an
`embodiment of the invention with a three-piece closure;
`FIG. 2|] is a schematic representation of an embodiment
`of the invention with a three-piece closure;
`FIGS. 21 and 22 are oblique, schematic representations of
`a valve leaflet closure useful according to the invention;
`
`4
`FIG. 23 is a partial cross-sectional view of the closure
`shown in FIGS. 21 and 22;
`FIG. 24 is an oblique, schematic representation of another
`valve leaflet closure useful according to the invention;
`FIG. 25 is a partial cross-sectional view of the closure in
`FIG. 24 in position;
`FIGS. 26 to 28 are each an oblique, schematic represen-
`tation of a spiral coil valve leallet closure useful according
`to the invention;
`FIG. 29 is an oblique schematic representation of a
`U-shaped valve leallet closure useful according to the inven-
`tion; and
`FIG. 30 is a partly cross—sectional view of the closure
`shown in FIG. 29.
`
`DETAILED I)ESCRlP'FlON OF THE
`INVENTION
`
`The invention can perhaps be better appreciated by mak-
`ing reference to the drawings. In FIG. 1 a portion of the
`human heart is depicted showing a mitral valve 10, a left
`ventricle 12 and the distal end 14 of a grasper apparatus of
`the invention 16, which has been inserted through an inci-
`sion IS in left ventricle I2. Incision 18 is loosely sutured
`with sutures 20 to loosely hold distal end 18 and to prevent
`bleeding.
`Mitral valve 10 comprises anterior leallet or cusp 22 and
`posterior leaflet or cusp 24, as well as two commissural
`cusps (not shown}. The primary intent of the invention
`herein is to secure the distal sections 26 and 28 of cusps 22
`and 24, respectively, together or substantially adjacent.
`As can be seen in FIG. 2, the jaws 30 of distal end 14 are
`separated and positioned exterior to cusps 22 and 24. Then,
`as shown in FIG. 3, jaws 30 are clamped together to cause
`cusp distal sections 26 and 28 to come together. Once a
`closure is embedded, such as the loop closure 32 in FIG. 4.
`jaws 30 are opened slightly so that distal section 14 can be
`withdrawn.
`
`The distal ends of the grasper means can vary greatly. It
`is contemplated that a variety of grasper means may be
`employed having diflering grasper configurations and ele-
`ments. For example,
`it
`is contemplated that
`the graspcr
`means could he of the type wherein one side of the grasper
`is stationary and the other side movable. Alternatively, the
`grasper means might be of the type wherein both sides are
`movable in concert. Another alternative arrangement com-
`prises a grasper means having multiple grasper elements to
`enable one to grasp and hold the leallets of the valve in
`multiple locations. It is also contemplated that the grasper
`elements themselves might comprise one or more suction
`elements to secure and hold the valve leaflets in place.
`Preferably the grasper will have the capacity to adjust the
`leaflets of. for example, a mitral valve to obtain optimal
`coaptation.
`In addition it is contemplated that the grasper may com-
`prise additional technology to facilitate the operation of the
`grasper. For example, the grasper may have echo doppler
`probe or a similar visualization technology that would allow
`even better localization of the leatlets and confirmation of
`ideal coaptation.
`FIG. 5 depicts the grasper end 36 of a perculaneous
`apparatus 38 with jaws 40 in the open position. Jaws 40 of
`grasper end 36 are movahly engaged about joint 42 such that
`the jaws may be easily and freely opened or closed by the
`operator of the percutaneous apparatus.
`Depicted in FIG. 6 is an embodiment of the invention
`showing one possible configuration of a fastener holder 44
`
`ill
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`15
`
`'
`
`30
`
`35
`
`40
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`45
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`50
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`55
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`60
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`0'5
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`US 6,269,819 B1
`
`5
`
`ill
`
`15
`
`5
`with a fastener clip 46 in place held in the open position for
`placement over the grasped leaflets of a mitral valve. The
`fastener holder 44 and fastener clip 46 may be integral with
`a grasper end as shown in FIG. 5 or separate from it,
`in
`which case it will be necessary to also provide a secondary
`percutaneous means for use in delivering and manipulating
`the fastener holder 44 and releasing and fixing the fastener
`clip 46 in the proper position about the leaves of a mitral
`valve, once they have been properly grasped by jaws 40 of
`grasper end 36.
`FIG. 7 is a more detailed schematic representation of the
`fastener holder 44 with its jaws 48 in their open position and
`fastener clip 46 in place in the open position (dotted line).
`Also shown is fastener clip 46 in its released, closed
`position. Fastc ncr clip 46, which may have a closed diameter
`of from about 3 to '2' mm, preferably about 5 mm, will be
`comprised of a suitable material such as stainless steel,
`nitinol, or titanium.
`FIG. 8 depicts a detailed, partly cross-sectional schematic
`representation of a preferred embodiment of the grasper
`device of the present invention, comprising grasper end 50,
`movable jaws 52 which are movably engaged about joint 54,
`in the open position, in proximity to valve leaflets 56. Each
`jaw 52 has a protruding grasping surface 58. However, the
`grasping surface 58 of one jaw 52 is operatively and slidably
`connected to a control member 60 to enable one to properly *
`align valve leaflets 56, prior to fastening.
`In FIG. 9 the grasper device of the apparatus of the
`invention shown in FIG. 8 is in a closed position. Moveable
`jaws 52 have protruding graspcr surfaces 58. which engage
`valve leaflets 56. Leaflets 56 are transloeated to a more
`optimum position for fastening by the action of control
`member 60 on one of protruding grasping surfaces 58, as
`shown in FIG. 11. Also, stapler action rod 68 is now
`opcrativcly connected to stapler control member 70.
`FIG. 10 is a schematic representation of a cross section of
`the adj ustablc graspcr depicted in FIG. 9. The jaws comprise
`grasper surfaces 58, an upper anvil 62 with recess 71, and a
`lower anvil 64 within which is located a staple type fastener
`66 to effect the fastening of valve leaflets.
`As shown in FIGS. 9, 11, and 12, lower anvil 64- has at
`least one slanted surface member 72. When stapler action
`rod 68 is forced distally against slanted surface member '72,
`stapler fastener 66 is forced through leaflets 56 into upper
`anvil 62 to close stapler fastener 66.
`In another embodiment ofthe invention shown in FIG.13,
`a graspcr 80 comprises jaws 82,84. Jaw 82 is movably
`connected to rod 86 at pivot point 87, and jaw 84 is movably
`connected at pivot point 88 to red 90. Rod 92 is movably
`connected to jaw 84 at pivot 94. Operation of rods 90 and 92
`causes jaws 82 and 34 to open and close on valve leaflets 96.
`Axial
`to graspcr 80 is a sheath 98 containing a drive
`mechanism 100 for rotating coil fastener 102. Coil fastener
`102 advances in a spiral mode piercing leaflets 96 in
`multiple locations as coil 102 is advanced into its linal
`position.
`Rods 86, 90, and 92 are each operatively connected to one
`or more control mechanisms {not shown). Also, distal sec-
`tion jaws 82,84 may be slidable within grasper sheath 81.
`Another device 110 ofthe invention is shown in FIGS. 14
`to 16, where jaws 112 are opcratively connected to a handle
`mechanism (not shown). Device 110 comprises a movable
`sheath 114 that contains a straightened closure fastener 116
`that is capable of resuming or forming a circular shape to
`coapt valve leaflets [not shown). Device III] has a slidably
`extruding grasping surface 118 that is operatively connected
`to the handle mechanism.
`
`6
`Once jaws [12 are closed, the distal tip of sheath 114 is
`advanced distally to be adjacent grasping surface 118 and its
`cooperating grasping surface 122. A pusher 124 coerces
`fastener 116 to advance out of the distal end 126 of sheath
`11410 form a circular shape. Fastener 116 in this shape will
`coapt valve leaflets 120, as can be seen in FIG. 17.
`The device 130 of the invention shown in FIGS. 18 and
`19 is intended to form a three-piece closure device. Jaws "132
`each rernovably hold a closure member 134 having a grasp-
`ing surface I36. Located axially with device 130 is a closure
`crirnper 138 that is remov-ably fastened at the distal end 140
`ofa device rod 142. When jaws 132 grasp valve leaflets 144,
`closu re crimper 138 is advanced distally by device rod 142
`to fit over the proximal ends of closure members 134. ‘lite
`closure formed is shown in FIG. 20.
`
`While a typical grasper means configuration would nor-
`mally require the use of at least one control wire to actuate
`the grasper element(s),
`it
`is contemplated that multiple
`separate control wires could also be effectively employed
`and manipulated from the proximal end of the system to
`allow for
`the precise control of the individual graspcr
`elements.
`
`With regard to the fastening means employed, as noted
`above it is contemplated that the fastening means may be
`constituted as a single apparatus operating in concert with
`the grasper means. Alternatively, the fastening means may
`be constituted as an entirely separate device which is totally
`independent of the grasper means. More preferably the
`fastening means will be a separate device which will func-
`tion using a monorail
`type system, wherein the fastening
`means will operate independently of the grasper means, but
`will ride via a loop over the same guidcwirefcatheter which
`houses and guides the grasper means.
`While the preferred fastener depicted is in the form of a
`clip or staple,
`it
`is also contemplated that
`the fasteners
`employed to secure the leaflets of the valve may be of a
`variety of different configurations, each of which would
`function with greater or lesser effectiveness depending upon
`the operative conditions which prevail. In addition to clips
`or staples it is also contemplated that the following types of
`fasteners may also be effectively employed: coils, sutures.
`dual button fasteners, culflink—lil<e fasteners, and the like.
`Suitable suture fasteners would include those which might
`require an appropriate mechanism to automatically suture
`tissue. Coil
`fasteners would generally be provided with
`sharpened ends to allow one to screw these fasteners into
`place by thwarting the sharpened end through the tissue of
`the valve leaflet.
`
`With reference to FIGS. 21 to 23 which depict a sequen-
`tial representation of the closure of valve leaflets using one
`preferred closure means. shown in FIG. 22 is a clip type
`closure 150 being inserted through valve leaflets 152. FIG.
`22 shows the clip type closure 150 in the fastened position.
`FIG. 23 is a cross-sectional view of the clip type closure 150
`depicted in FIG. 23. Each closure 150 as shown in l-‘IG. 21
`would have a thickness of from about 0.5 to 1.8 mm,
`preferably about l min, a width of from about 0.3 to 0.7 cm,
`preferably about 0.5 cm. and a length of from about 0.6 to
`1.4 cm, preferably about 1 cm.
`FIGS. 24 and 25 are each a schematic representation of
`the insertion of another preferred closure means of the
`invention. A staplc—typc closure 156 is inserted through
`valve leaflets 158, and then closed, as shown in FIG. 26.
`Closure 156 would preferably have an overall
`length
`(including sides) of from about 1 to 4 cm, preferably about
`3 cm, an effective diameter of from about 0.1 to 0.5 mm.
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`
`Page 1 of 22
`
`30
`
`35
`
`4-0
`
`45
`
`50
`
`_
`
`60
`
`05
`
`NeoChord v. Univ of Maryland
`Exhibit 1010
`Page 1 of 22
`
`

`
`US 6,269,819 B1
`
`7
`preferably about 0.3 mm, and an opening of from about 0.5
`to 1.3 cm, preferably about 1 cm.
`FIGS. 26 to 28 are each a schematic representation of the
`insertion of yet another preferred closure. A spiral coil
`closure 160 can be inserted across valve leaflets 162 in
`longitudinal. latitudinal, or transverse fashion, by use of, for
`example,
`the device shown in FIG. 13. Coils 160 will
`preferably have pointed ends and will have external dimen-
`sions comprising a length of from about 3 to 7 cm, prefer-
`ably about 5 cm, and a diameter of from about 1 to 3 mm,
`preferably about 2 mm.
`The overall diameter andfor the differential turns of coil
`160 may be uniform or they may vary. For example, the
`diameter at each end of coil 160 could be the same as,
`greater than, or less than the diameter of the middle portion
`of the coil. Similarly, the ratio of the turns of the coil to the
`length, i.e., the pitch, could be consistent or the pitch could
`be greater or less at each end of the coil. The diameter of the
`coil wire will preferably be consistent.
`Each coil 160 would have a length of from about 3 to 7
`cm, preferably about 5 cm, with a diameter of from about 1
`to 3 mm. preferably about 2 mm, and a coil wire diameter
`offrom about 0.2 to 0.4 mm. The winding ofcoil 160 should
`be from about 5 to 10 turnstcm in an unstressed condition.
`In “US. 29 and 30 a U-shaped barbed clip-type closure
`164 is applied to leaflet 166.
`The device and fasteners used according to the invention
`must be comprised of biocompatihle, nonimrnunogenic
`materials. The grasper is preferably comprised of rigid
`materials such as titanium, nitinol, stainless steel, or rigid
`polymeric material such as polyethylene or polyurethane.
`The clips, staples, coils, etc., are preferably comprised of
`titanium, nitinol, or stainless steel. In some instances fas-
`teners comprised of molded polymeric material may also be
`useful.
`
`There are four different approaches which one might take
`to effect a repair of the mitral heart valve according to the
`invention:
`
`ill
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`30
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`35
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`40
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`Such a procedure might be undertaken while the patient is
`on by-pass with an open -chest, either transapically or tran-
`satrially. A median stemotomy is performed and the patient
`is placed on cardiopulmonary bypass by cannulating the
`ascending aorta and the right atrium. A purse—string suture is
`then placed on the apex of the left ventricle and a stab
`incision performed to insert the instrument which will grasp
`and attach the mitral valve leaflets. Once adequate repair of
`the valve is attained, the instrument is removed and the air
`evacuated from