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`USOU?635386B1
`
`(12) United States Patent
`Gammie
`
`(10) Patent No.:
`(45; Date of Patent:
`
`US 7,635,386 B1
`Dec. 22, 2009
`
`(54) METHODS AND DEVICES FOR
`PERFORMING CARDIAC VALVE REPAIR
`
`.=\l*
`2006.-'U|67S4i
`2007.-'D| 12422 Al "‘
`2009.-0005863 .-’\l *
`
`I.altou|'
`T.-‘"2006
`5.-‘"2007 Dehdashtian ..
`l.-‘Z009 Cxoetzetal.
`
`
`
`623.-2.ll
`623.-"2.ll
`52352.18
`
`(75)
`
`Inventor:
`
`James S. Gammie. Stevenson. MI) (US)
`
`FOREIGN PATENT DOCUMENTS
`
`(73) Assignee: University of Maryland, Baltimore.
`Baltimore. MD (US)
`Subject to any disclaimer. the term of this
`patent is extended or adjusted under 35
`UISICI 1540)) by 296 days‘
`
`[ * ) Notice:
`
`T.-"2006
`
`W0 2t)t)fii't]7Rfi94
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`Prifljam, Emm‘,-Hm, Suzene J Gherbi
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`quire,
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`S‘ d
`"I.l1 ers
`
`& D
`
`,
`empsey
`
`(21) Appl. No.: 111633.282
`
`(57)
`
`ABSTRACT
`
`The present invention is directed to nietliods and devices for
`repairing a cardiac valve. Generally. tiie metliods involve a
`minirnaily iiivasive procedure that includes creating an access
`in the apex region of the heart tliroilgh wliieli one or more
`instrtliiients may be inserted so as to repair a cardiac valve. for
`instance. a niitia] or tricuspid valve. Accordingly. the meth-
`ods are Liseful for perlbrmiiig a variety ofprocediires to effec-
`mate a repair. For instance. in one embodinienl. the methods
`are useful for repairing a cardiac valve by iniplaiiting one or
`nitire anificial heart valve chordae teridtnae into one or more
`cardiac valve leaflet tissues so as to restore the proper leaflet
`luriclion and {hereby prevent reperttisioii. In another en1bod.i-
`ment. the methods are usefiil for repairing a cardiac valve by
`resecting a portion of one or more cardiac valve Ieatlets and
`inipiaiiting one orrnore sutures into the resected valve tissues.
`vvliicli may also include the ‘niiplantat t0tt 01 an aiuiiiloplasty
`ring. In an a(.l(.l]l.l('Il'lE:llL3l'l'll')t_‘IClI1'I'1(!I'1T.. the methods are uselul [or
`Perl"or111ir1g an edge to edge bow-tie repair (L32.
`a11 /tllieri
`l
`.‘
`‘
`‘
`‘
`‘-
`repair) on cardiac valve tissues. Dcvic-es liir performiiig the
`methods of the uivention are also provided.
`
`23 Claims, 9 Drawing Sheets
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`
`Page 1 of21
`
`(22)
`
`Filed:
`
`Mar‘ 7‘ 2007
`,
`_
`,
`Related Uh‘ Appllcatmn Data
`(60) Provisional application No. 6()i'780.52l. filed on Mar.
`7. 2006.
`
`(S1 }
`
`Int. C l.
`A6IF 2/24
`623.-"2.l1: 6232904
`(52) U.S. (fl.
`lgggggg;
`(53) Field ofchssjficafion Search
`(,f)”,-‘f9; 523,11} 2_37_ 90.5,
`5._-._- app] ic;{[_i(]11 fi1._- fgr cgmplcm 5{_-m-C11 hj 519,1-y_
`
`(2006.01)
`
`(56)
`
`Rd‘-'r°""°" (“ed
`U ‘S’ PAv1—]3N-I- DOCUMENTS
`
`533-31
`1-9900 D0nl0fl 9131-
`51319-531 A *
`128393
`1-""3005 D0W|'|i|'l3
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`EI.973.l'r'6 B2 '“
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`2006.-"0l00698 Al “’
`S.-‘"2006
`I..al‘Lo1.Ii' .................... .. 623-'2.ll
`
`
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`U.S. Patent
`
`Dec. 22, 2009
`
`Sheet 1 of9
`
`US 7,635,386 B1
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`U.S. Patent
`
`Dec. 22, 2009
`
`Sheet 2 of9
`
`US 7,635,386 B1
`
`704
`
`FIG.
`
`.3
`
`202
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`U.S. Patent
`
`Dec. 22, 2009
`
`Sheet 3 of9
`
`US 7,635,386 B1
`
`mo\
`
`4.30
`
`*9‘
`
`410
`
`440
`
`F/G. 4
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`FIG. 5
`
`524
`
`420
`
`4”’
`
`520
`
`522
`
`\fi5o4
`3:
`
`550
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`U.S. Patent
`
`Dec. 22, 2009
`
`Sheet 4 of9
`
`US 7,635,386 B1
`
`«IzrJw.y,,
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`U.S. Patent
`
`Dec. 22, 2009
`
`Sheet 5 of9
`
`US 7,635,386 B1
`
`NeoChord v. Univ of Ma
`
`Exhibi
`
`nd
`
`1
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`U.S. Patent
`
`Dec. 22, 2009
`
`Sheet 6 of9
`
`US 7,635,386 B1
`
`87
`
`8.90
`
`J
`
`330
`
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`
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`870
`
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`I
`
`F/G. 80
`
`Exhibit 1001
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`U.S. Patent
`
`Dec. 22, 2009
`
`Sheet 7 of 9
`
`US 7,635,386 B1
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`U.S. Patent
`
`Dec. 22, 2009
`
`Sheet 8 of9
`
`US 7,635,386 B1
`
`1025
`
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`
`1005
`
`I030
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`
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`
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`
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`
`70C
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`U.S. Patent
`
`Dec. 22, 2009
`
`Sheet 9 of9
`
`US 7,635,386 B1
`
`7030
`
`1025
`
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`
`7 7 B
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`1020
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`
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`
`7 7C
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`US ?,635,386 B1
`
`1
`METHODS AND DEVICES FOR
`PERFORMING CARDIAC.‘ VALVE REPAIR
`
`CROSS-REFERENC E TO RELATED
`APPl.,lC.t\TlONS
`
`This patent application claims the benefit of U.S. Provi-
`sional Patent Application No. 60f780.S2l. filed Mar. 7. 2006.
`the content ofwhich is incorporated herein by reference in its
`entirety.
`
`1U
`
`l’Ilil..l') OF TI--IF, IN)/F.N'l"lON
`
`The invention relates to methods and devices for perform-
`ing cardiac valve repairs. Specifically, the invention relates to
`methods for performing mitral or tricuspid valve repairs.
`
`BACKGROUND OF THE lNV"EN'l'ION
`
`As illustrated in FIG. 1, the human heart (10) has four
`chambers which include two upper chambers denoted as atria
`(12, 16) and two lower chambers denoted as ventricles (14.
`18). A septum (20) divides the heart and separates the left
`atrium (12) and lefi ventricle (14) from the right atrium (16)
`and right ventricle (18). The heart litrther contains four valves
`(22. 24. 26 and 28). The valves function to maintain the
`pressure and unidirectional llow of the blood through the
`body and to prevent the blood front leaking back into a cham-
`ber froni which it has been pumped.
`‘l'wo valves separate the atria (12. 16) from the ventricles
`(14. 18). denoted as atriovcntrieular valves. The left atrioven-
`tricular valve. the mitral valve (22). controls the passage of
`oxygenated blood from the left atrium (12) to the left ventricle
`(14). A second valve, the aortic valve (24). separates the left
`ventricle (14) from the aortic artery (aorta) (30), which del iv-
`ers oxygenated blood via the circulation to the entire body.
`The aortic and mitral valves are part of the “left"l1eart, which
`controls the flow of oxygen-rich blood from the lungs to the
`body. The right atrioventricular valve. the tricuspid valve
`(26), controls passage ofdeoxygenated blood into the right
`ventricle (18). A fourth valve.
`the pulmonary valve (28).
`separates the right ventricle (18) from pulmonary artery (32).
`The right ventricle (18) pumps deoxygenated blood through
`the pulmonary artery (32) to the lungs wherein the blood is
`oxygenated and then delivered to the left atrium (12) via the
`pulmonary vein. Accordingly.
`the tricuspid (26) and pul-
`tnonic (28) valves are part of the "right" heart. which control
`the flow ofoxygen-depleted blood from the body to the lungs.
`Both the left and right ventricles (14 and 18, respectively)
`constitute “punJping“ chambers. The aortic (24) and pit]-
`monic (28) valves lie between a ptnnping chamber" (ventricle)
`and a major artery and control the flow of blood out of the
`ventricles and into the circulation. 'lhe aortic and pulmonary
`valves have three cusps. or leaflets. that open and close and
`thereby function to prevent blood from leaking back into the
`ventricles after being ejected into the lungs or aorta for cir-
`culation.
`
`Both the lefl and right atria (14 and 16, respectively) are
`“receiving" chambers. The mitral (22) and trieuspid (26)
`valves. therefore. lie between a receiving chamber (atrium)
`and a ventricle so as to control the flow ofblood from the atria
`
`to the ventricles and prevent blood from leaking back into the
`atrium during ejection into the ventricle. Both the mitral (22)
`and tricuspid (26) valves include two or more cusps. or leaf-
`lets (not shown). that are encircled by a variably dense fibrous
`ring of tissues known as l.l1c armulus (not shown). The valves
`are anchored to the walls of the ventricles by ehordae
`
`3U
`
`35
`
`4t":
`
`45
`
`50
`
`55
`
`60
`
`2
`tendineae (chordae) (42). The ehordae tendineae (42) are
`cord-like tendons that connect the papillary muscles (44) to
`the lea [lets (not shown) of the mitral (22) and the tricuspid
`(26) valves of the heart (10). The papillary muscles (44) are
`located at the base of the chordae (42) and are within the walls
`of the ventricles. They serve to limit the movements of the
`mitral (22) and trlcuspid (26) valves and prevent them from
`being reverted. The papillary muscles do not open or close the
`valves of the heart_. which close passively in response to
`pressure gradients: rather. the papillary muscles brace the
`valves against the high pressure needed to circulate the blood
`throughout the body. Together. the papillary muscles (44) and
`the chordac tendineae (42) are known as the subvalvular
`apparatus. The function of the subvalvular apparatus is to
`keep the valves from prolapsing into the atria when they
`close.
`As illustrated with reference to FIG. 2. the mitral valve
`(100) includes two leaflets, the anterior leaflet (102) and the
`posterior leaflet (104). and a diaphanous incomplete ring
`around the valve, the annulus (I 10). 'lhe mitral valve contains
`two papillary muscles (not shown). the anteromedial and the
`posterolateral papillary muscles. which attach the leaflets to
`the walls of the left ventricle via the chordae tendineae (not
`shown). The tricttspid valve typically is made tip of three
`leaflets and three papillary muscles. However. the number of
`leaflets can range between two and four. The three leaflets of
`the tricuspid valve are referred to as the anterior. posterior.
`and septal leaflets. Although both the aortic and pulmonary
`valves each have three leaflets (or cusps) they do not have
`chordae tertdineae.
`
`Various disease processes can impair the proper function-
`ing of one or more of the valves of the heart. These disease
`processes include degenerative processes (eg. l3arlow‘s Dis-
`ease. libroelastic deficiency). inllamntatory processes (e.g..
`Rheuntatic Heart Disease) and infectious processes (eg.
`endocarditis). Additionally. damage to the ventricle from
`prior heart attacks (i.e.. myocardial infarction secondary to
`coronary artery disease) or other heart diseases (e.g.. cardi-
`omyopathy) can distort the valve's geometry causing it to
`dysfunction. However. the vast majority of patients undergo-
`ing valve surgery. such as ntitral valve surgery. suller from a
`degenerative disease that causes a malfunction in a leaflet of
`the valve which results in prolapse and regurgitation.
`Generally. there are two different ways that a heart valve
`may malfunction. One possible malfunction, valve stenosis,
`occurs when a valve does not open completely and thereby
`causes an obstruction ofblood flow. Typically. stenosis results
`from buildup ofcalcilied material on the leaflets ofthc valves
`causing them to thicken and thereby impairing their ability to
`fully open and permit adequate forward blood flow.
`Another possible malfunction. valve regurgitation occurs
`when the leaflets ofthe valve do not close completely thereby
`causing blood to leak back into the prior chamber. There are
`three meclranisms by which a valve becomes regurgitartt or
`incompetent: they include Carpentier‘s type I. type ll and
`type Ill malfunctions. A Carpentier type ] ntalfunction
`involves the dilation of the annulus such that normally finic-
`tioning leaflets are distracted from each other and hail to form
`a tight seal (i.e.. do not coapt properly). Included in a type I
`mechanism malfunction are perforations of the valve leaflets,
`as in endocarditis. A Carpentier‘s type ll malfunction
`involves prolapse of one or both leaflets above the plane of
`coaptation. This is the most common cause of rnitral regur-
`gitation. and is often caused by the stretching or rupturing of
`chordae tendinae normally connected to the leaflet. A Car-
`pentier‘s type III malfunction involves restriction of the
`motion ofone or more leaflcfi éua
`atotlri - lt\.‘;illlEEl$rifi‘(\."/iil61¥)R-/Iaryland
`Exhibit 1001
`
`Page 1 of 21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`3
`
`4
`
`US ?.635,386 B1
`
`mally constrained below the level ofthe plane ofthe annulus.
`Leaflet restriction can be caused by rheumatic disease (Illa)
`or dilation of the ventricle (lllb).
`FIG. 3 illustrates a prolapsed mitral valve (200). As can be
`seen with reference to FIG. 3. prolapse occurs when a leaflet
`(202 or 204) ofthe mitral valve (200) is displaced into the left
`atrium during systole. Because one or more of the leaflets
`malfunction the valve does not close properly. and. therefore.
`the leaflets fail to coapt. This failure to eoapt causes a gap
`between the leaflets (202 and 204) that allows blood to [low
`back into the left atrium, during systole, while it
`is being
`ejected into the left ventricle. As set forth above. there are
`several different ways a leaflet may malfunction, vvllich can
`thereby lead to regurgitation.
`Although stenosis or regurgitation can aflect any valve,
`stenosis is predominantly found to affect either the aortic and
`pulmonary valves. whereas regurgitation predominately
`aifects either the mitral or tricuspid valve. Both valve stenosis
`and valve regurgitation increase the workload on the heart and
`may lead to very serious conditions if left tm-treated; such as
`endocarditis. congestive heart failure, permanent heart dam-
`age. cardiac arrest and ultimately death. Since the left heart is
`primarily responsible for circulating the flow of blood
`throughout the body. malfunction of the mitrai or aortic
`valves is particularly problematic and ofien life threatening.
`Accordingly. because u fthe substantially higher pressures on
`the left side of the heart. left-sided valve dysfunction is much
`more problematic.
`Malfunctioning valves may either be repaired or replaced.
`Repair typically involves the preservation and correction of
`the patient‘s own valve. Replacement
`typically involves
`replacing the patient‘s malfunctioning valve with a biological
`or mechanical substitute. Typically. the aortic and the pulmo-
`nary valves are more prone to stenosis. Because stertotic
`damage sustained by the leaflets is irreversible. the most
`conventional
`treatment for stenotic aortic and pulnionic
`valves is the removal and replacement of the diseased valve.
`The mitral and the tricuspid valves, on the other hand, are
`more prone to deformation. Deformation of the leaflets. as
`described above. prevents the valves limit closing properly
`and allows for regurgitation or back [low from the ventricle
`into the atrium, which re stilts in valvular insufficiency. Defor-
`mations in the structure or shape of the mitral or tricuspid
`valve are often repairable.
`Valve repair is clearly preferable to valve replacement.
`Bioprosthetic valves have limited durability. Secondly. pros-
`thetic valves rarely function as well as the patient’s own
`valves. Additionally. there is an increased rate of survival and
`a decreased mortality rate and incidence of endocarditis for
`repair procedures. Further, because of the risk ofthromboem—
`bolism, mechanical valves often require further maintenance,
`sucl1 as the lifelong treatment with blood thinners and ar1ti-
`coagulants. 'l'herefore_. an improper functioning mitral or tri-
`cuspid valve is ideally repaired. rather than replaced. How-
`ever. because of the complex and technical demands of the
`repair procedures. the overall repair rate in the United States
`is only around 50%.
`Conventional teclmiques for repairing a cardiac valve are
`labor-intensive. technically cliallenging. and require a great
`deal of hand-to-eye coordination. They are. therefore. very
`challenging to perform. and requirea great deal ofexperience
`and extremely good judgment. For instance. the procedures
`for repairing regurgitating leaflets may require resection of
`the prolapsed segment and insertion ofan armuplasty ring so
`as to reform the annulus of the valve. Additionally. leaflet
`sparing procedures for correcting regttrgitation are just as
`labor-intensive and technically cltallenging, if not requiring
`
`5
`
`Ill
`
`1:-
`
`25
`
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`
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`
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`
`45
`
`50
`
`55
`
`60
`
`65
`
`an even greater level ofhand-to-eye coordination. These pro-
`cedures involve the implantation of sutures (c.g.. el”l'l'-‘li or
`(EORE-TEXW sutures) so as to fomi artificial chordae in the
`valve. In these procedures. rather than performing a resection
`of the leaflets anclfor implanting an annuplasty ring into the
`patient‘s valve. the prolapscd segment of the leaflet is re-
`snspended using artificial chord sutures. Ofientimes, leaflet
`resection. annttplasty and neo-cord implantation procedures
`are performed in conjunction with one another.
`Regardless ofwhether a replacement or repair procedure is
`being performed, conventional approaches for replacing or
`rcpairi ng cardiac valves are typically invasive open-heart sur-
`gical procedures, such as stcrnotorny or thoracolorny. that
`require opening up of the thoracic cavity so as to gain access
`to the heart. Once the chest has been opened. the heart is
`bypassed and stopped. Cardiopulmonary bypass is typically
`established by inserting cannulae into the superior zmd infe-
`rior vena cavae (for venous drainage) and the ascending aorta
`[for arterial perfusion]. and connecting the eannulae to a
`heart-lung machine, which functions to oxygcnate the venous
`blood and pump it
`into the arterial circulation,
`thereby
`bypassing the heart. Once cardiopulmonary bypass has been
`achieved, cardiac standstill is established by clamping the
`aorta and delivering a “cardioplegia" solution into the aortic
`root and then into the coronary circulation. which stops the
`heart from beating. Once cardiac standstill has been achieved.
`the surgical procedure may be performed. These procedures.
`however. adversely affect almost all of the organ systems of
`the body and may lead to complications. such as strokes.
`myocardial “stunning” or damage, respiratory failure, kidney
`failure. bleeding. generalized inflammation. and death. The
`risk of these complications is directly related to the amount of
`time the heart is stopped (“cross-clamp time") and the amount
`of time the subject is on the heart-lung machine (“pump
`time“).
`Furthermore. the conventional methods currently being
`practiced for the implantation of the artificial chordae are
`particularly problematic. Because the conventional approach
`requires the heart to be stopped (c.g.. via atriotomy) it is
`diflicult to accurately detcnnine. assess and secure the appro-
`priate chordal length. Since the valve will not function prop-
`erly if the length of the artificial chordae is too long or too
`short, the very problem sought to be eradicated by the chordal
`replacement procedure may. in fact. be exacerbated. Using
`conventional techniques. it is very difficult to ensure that the
`chordae are ofthe correct length and are appropriately spaced
`inside the ventricle to produce a competent valve.
`Accordi ngly, there is a continuing need for new procedures
`for performing cardiac valve repairs. such as mitral and tri-
`cuspid valve repairs. that are less invasive_. do not require
`cardiac arrest. and are less labor—intensive and technically
`challenging. Chordal replacement procedures that ensure the
`appropriate chordal ler1gtl1 and spacing so as to produce a
`competent valve are of particular interest. The methods pre-
`scnted herein meet these needs.
`
`SUMMARY OF THE INVENTION
`
`Methods and devices for repairing a cardiac valve are
`herein provided. Generally. the methods involve a minimally
`invasive procedure that includes creating an access in the apex
`region of the heart through which one or more instrurnents
`may be inserted so as to repair a cardiac valve. for instance. a
`mitral or trictispid valve. Accordingly. the methods are useful
`for performing a variety of procedures to effectuate a repair.
`For instartce. in one embodiment. the methods are useful for
`
`repairing a cardiac valve gr
`
`1ig|.'<;tiggii\l/Iaryland
`Exhibit 1 001
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

`
`5
`heart valve chordae tendineae into one or more cardiac valve
`leaflet tissues so as to restore the proper leaflet function and
`thereby prevent valvular regurgitation. In another embodi-
`ment. the methods are useful for repairing a cardiac valve by
`resecting a portion of one or more cardiac valve leaflets and
`implanting one or more sutures into the resected valve tissues.
`which may also include the implantation ofan annuloplasty
`ring. In an additional embodiment. the methods are useful for
`performing an edge-to-edge, bow-tie repair (e.g._. an Alfieri
`repair) on cardiac valve tissues. Devices for performing the
`methods of the invention are also provided.
`Accordingly. in certain embodiments. the methods involve
`a minimally invasive procedure for repairing a cardiac mitral
`or tricuspid valve. In certain embodiments,
`the methods
`include accessing a mitral valve through the apex region of
`tlie left ventricle or accessing a tricuspid valve through the
`apex region of the right ventricle so as to perform a leaflet
`repair procedure andfor implant one or more implantable
`devices into the tissue of the mi tral or tricuspid valve or the
`surrounding tissue. The implantable devices may include
`sutures. prosthetic or artificial chordae. annuplasty rings or
`portions thereof. clips. anchors. manifolds. ports. and other
`such elements configured to support andfor buttress a cardiac
`repair.
`The present invention further includes methods for anchor-
`ing the implanted devices. as well as methods for properly
`knotting [e.g.. tying) implanted sutures in such a way that the
`appropriate length and height of the sutures (e.g. . fitnctioning
`as replacement chordae) can be measured. determined. and
`adj usted. as necessary, before finishing the procedure. The
`methods further include evaluating cardiac valve liinction
`before tying off andfor cutting implanted sutures.
`'lhese and other features. objects and advantages of the
`invention will become apparent to those persons skilled in the
`art upon reading the details of the invention as more fully
`described below.
`
`l3RII-IF [)1iSCRll"I‘lONS OF TI-[Ii DRAWINGS
`
`is a cut-away anterior view of the human heart
`I
`FIG.
`showing the internal chambers. valves and other adjacent
`structures.
`
`FIG. 2 is a perspective view ofa healthy mitral valve with
`the leaflets closed and coapting at peak contraction pressures
`during systole.
`FIG. 3 is atop view of a dysfunctional mitral valve result-
`ing in poor coaptation of the leaflets with a visible gap
`between them which results in regurgitation ofblood into the
`left atrium during systolic contraction.
`FIG. 4 illustrates an apex region ofa heart with four cham-
`bers.
`
`FIG. 5 illustrates an access created in the apex region ofthe
`heart.
`
`3U
`
`35
`
`4t":
`
`45
`
`50
`
`FIG. 6 illustrates the advancement ofa device through an
`accessed region of the heart in accordance with the methods
`of the invention.
`
`55
`
`FIG. 7A illustrates a proplapsed mitral valve.
`FIG. Tl} illustrates an instrument advanced into a left ven-
`
`tricle of the heart so as to repair a prolapsed mitral valve.
`FIGS. SA-8C illustrate an exemplary repair procedure of
`the invention.
`
`60
`
`FIG. 9 illustrates a m itral valve repaired in accordance with
`the methods of the invention.
`
`FIGS. l0A—C depict the parts ofan example ofa device that
`can be used in the repair methods described herein.
`FIG. 11A is a side view of a partially assembled device
`comprising the parts of FIGS. 10A-C.
`
`US ?.635,386 B1
`
`6
`
`FIG. 11B is a cross-sectional view of the cap (1025) and
`silicone insert ( 1030) of FIG. 1 1A.
`FIG. HC is a cross-sectional view ofthe main body (1085)
`and its channels (1015 and 1070}.
`
`Dli'l‘./\II.l'.7.l) [)1 ".SCRIP'l'I()N 01'' TI ll! lNVF.NTI()N
`
`IU
`
`The methods disclosed herein set forth minimally invasive
`procedures that both simplify and expedite cardiac valve
`repairs. Unlike conventional protocols, the methods herein
`presented do not involve invasive surgical procedures and do
`not require cardioplegic arrest andfor lengthy cardiopuliuo-
`nary bypass. Rather the methods of the invention may be
`performed while the heart is still beating, thereby reducing if
`not entirely avoiding pump and cross—cIamp time. minimiz-
`ing pain and traurna. and promoting rapid recovery.
`In order to perfomt a cardiac valve repair of the invention.
`one or tnore chambers of the heart must be accessed. Rather
`
`than requiring open heart surgery as a means of accessing a
`chamber of the heart. which necessitates the stopping and
`bypassing of the heart by an extraoorporeal circulation
`device. the methods of the invention are performed in a mini-
`mally invasive manner. Using small incisions. specialized
`instrurnents. andlor videofaudio-scopic assistance [e.g..
`endoscopy) the heart may be contacted. the chambers ofthe
`heart may thereby be accessed. and a cardiac valve repair
`procedure performed. These methods may also be performed
`in a completely percutaneous manner: for instance via the
`femoral or internal jugular veins. via the inter—atrial septum
`(trans-septal) and then into the left atrium_. or via a retrograde
`approach {femoral artery. across aortic valve).
`Accordingly.
`the invention is directed to methods for
`repairing a defective cardiac valve. Specifically. the invention
`is directed to methods for repairing at cardiac mitral or tricus-
`pid valve so as to redttce or prevent regurgitation. The meth-
`ods for repairing a defective or malfunctiom'ng mitral or tri-
`cuspid valve generally include creating an access in the apex
`region of the heart through which the defective valve may be
`accessed and introducing a device through the access so as to
`repair the cardiac valve by use of tlie introduced device.
`Typically a device for use in accordance with the methods
`of the invention is configured for implanting one or more
`other devices (e.g.. sutures) into the tissue ofthe cardiac valve
`so as to repair the valve and reduce or prevent regurgitation.
`The tissue within which the one or more devices may be
`implanted so as to effectuate said repair may be any appro-
`priate tissue such as. but not limited to: an annulus tissue. a
`leaflet tissue. a chordae tendincae tissue. at papillary muscle
`tissue. a proximal ventricular tissue, a distal ventricular tis-
`sue. an internal or external tissue in the apex region of the
`ventricle. and./or other suitable myocardial sites. such as the
`epicardium or pericardium. The methods of the invention will
`now be described in greater detail herein below.
`In accordance with the methods of the invention. the heart
`may be accessed through one or iuore openings made by a
`small incision(s) in a portion of the body proximal to the
`thoracic cavity, for instance. in between one or more of the
`ribs of the rib cage, proximate to the xyphoid appendage. or
`via the abdomen and diaphragm. Access to the thoracic cavity
`may be sought so as to allow the insertion and use ofone or
`tnore thorascopic instruments. while access to the abdomen
`may be sought so as to allow the insenion and use of one or
`more Iaparoscopic instruments. Insertion ofone or more visu-
`alizing instruments may then be iollowed by transdiaphrag—
`matic access to the heart. Additionally. access to the heart may
`be gained by direct puncture (i.c.. via an appropriately sized
`needle. for instance an 18 t1\1/e iI\‘t;t‘t15I lwlaryland
`Exhibit 1 001
`
`Page 1 of21
`
`NeoChord v. Univ of Maryland
`Exhibit 1001
`Page 1 of 21
`
`

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`7
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`8
`
`US ?,635,386 B1
`
`Ill
`
`the reparative cardiac valve procedure. At this point. the prac-
`titioner can confinn tl1at access of one or more cardiac valves
`
`xyphoid region. Access may also be achieved using percuta-
`neous means {see above). Accordingly. tlte one or more inci-
`through the apex of the heart is appropriate for the particular
`sions should be made in such a manner as to provide an
`procedure to be performed.
`appropriate surgical held and access site to the heart. See for
`Suitable devices for use with the methods of the invention
`instance. I-‘ull-Spgptrum Cardiac Surgery Through a Minimal
`are well-known in the art and are commercially available.
`Incision Mini-Stcmotomy (Lower Hall) Teclutique Doty et
`Typically. the devices are for use in grasping, cutting andlor
`al. Annals ofThoracic Surgery 1998: 65(2): 573-7 and Tran-
`suturing one or tnore tissues ofthe heart from a point ofentry
`sxiphoid Approach Without Median Stemotorny for the
`into the body that is remote from (e.g.. distal to) the heart.
`Repair ofAtrial Septal l')efects. Bat-bero-Marcial et al. Annals
`Accordingly. a suitable device may be a flexible. elongate
`ofThoracic Surgery 1998; 65(3): 771-4 which are specifically
`member (for instance, a shaft) with a grasping. cutting andfor
`incorporated in their entirety herein by reference.
`suturing means attached to the distal end portion of the elon-
`After prepping and placing the subject under anesthesia a
`gate member. The elongate member may be a cannula. cath-
`transesophageal ochocardiog_rat11('l1'it5E) (2[) or 31)}, a tran-
`eter. or the like. A trocar or sheath tnetnber may also be used
`sthoracic echocardiogram UTE], intracardiac echo (ICE). or
`cardio-optic direct visualization (e.g.. via infrared vision is in cortjunction with the use ofthe device so as to facilitate
`front the tip ofa 7.5 F catheter) may be performed to assess
`entry and advancement of the device.
`the heart and its valves. A careful assessment of the location
`The elongate member. for instance. a can.nttla. is usttally of
`and type of dysfunction on the TEE. TTE, or other such
`aproportion and circumference to facilitate introduction into
`instrument. liieilitates the planning ofthe appropriate surgical
`the thoracic cavity. through a minimal incision made in the
`procedure to be perfonned. The use ofTlzili. 'I"I'I'i. I(.‘l.€. or the an subjec1’s tissue. and of a shape configured to promote
`like. can assist in determining if there is a need for adjunctive
`advancement of the instrument so as to contact and provide
`procedures to be performed on the leaflets and subvalvular
`entry intothe heart.The diameter ofthe cannula may be about
`apparatus and can indicate whether a minimally invasive
`0.5 mm to about 10mm. but is typically about 5 mm. The
`approach is advisable.
`cannula may include one or a number of shaft members.
`Once a minjtnally invasive approach is determined to be 25 grasping members. needle mernbers.threading members. de-
`advisabie. one or more incisions are made proximate to the
`threading members. and the like that may be movcably
`thoracic cavity so as to providea surgical field of access. The
`coupled to one another. Furthermore. the cannula may be
`total nuntberand length ofthe incisions to bemade depend on
`provided with a visual monitoring means such as an endo-
`the number and types ofthe instruments to be used as wellas
`scope. an ultrasound probe, or the like. so as to check the
`the procedure(s) to be performed. The incision(s} should be 3m position of the device in the chest or in the1teart.Aclditio11ally.
`made in such a manner so as to be minimally invasive. By
`the cannula may be provided with suction or vacuum means
`“minimally invasive" is meant in a mamter by which an inte-
`configured for attaching and positioning a desired tissue rela-
`rior organ or tissue may be accessed with as little as possible
`tive to the cutting andfor suturing means of the device. For-
`damage being done to the anatomical structure through which
`thcr. the cannula may include an additional shalt configured
`entry is sought. Typically, a minimally invasive procedure is
`35 for delivering a medicament, such as an in_fusion of heparin.
`one that involves accessing a body cavity by a small incision
`saline forirrigation. or the like to a chamber ofthe heart where
`tnade in the skin ofthe body. By “small incision" is meant that
`the procedure is being performed.
`the length of the incision generally should be about 1 cm to
`Additionally. suitable devices for use with the methods of
`about 10 cm. or about 4 cm to about 8 cm. or about 7 cm in
`the invention include a handle portion capable of being
`length. Additionally. where direct needle access to the heart is 40 manipulated so as to finely control the movements of the
`sought. the methods o I‘ the invention may be performed with
`distal portion members [e.g.. the gr