PCT
`WORLD TNTELLECTUAL PROPERTY ORGANIZATION
`International Bureau
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(51) International Patent Classification 7 :
`WO 00/15147
`A61F 2/06
`
`(43) International Publication Date:
`
`23 March 2000 (23.03.00)
`
`(11) International Publication Number:
`
`Al
`
`(21) International Application Number:
`
`PCT/US99/207 I 4
`
`(22) International Filing Date:
`
`10 September 1999 (10.09.99)
`
`(30) Priority Data.:
`60/099,767
`60/104,397
`60/147,202
`60/147,218
`09/369,048
`
`10 September 1998 (10.09.98) US
`15 October 1998 (15. 10.98)
`US
`4 August 1999 (04.08.99)
`US
`4 August 1999 (04.08.99)
`US
`4 August 1999 (04.08.99)
`US
`
`I I 11 Crestview Way, Goshen, KY 40026 (US). GRIFFIN,
`Mark [US/US]; Apartment 3, 41 13 Bridgewood Court,
`Louisville, KY 40241 (US). WOLF, Scott, J. [US/US);
`2501 Irvine Avenue South, Minneapolis, MN 55405 (US).
`WILK, Peter, J. [US/US); 185 West End Avenue, New
`York, NY 10023 (US). SCHMELTER, Jay, W. [US/US];
`6090 Annapolis Lane North, Plymouth, MN 55466 (US).
`FURNISH, Simon, M. [US/US]; 2429 Longest Avenue,
`Louisville, KY 40204 (US). RENA TI, Richard, J. [US/US];
`* (US). MELSKY, Gerald [US/US]; * (US). GUILES,
`Marvin [US/US]; * (US).
`
`(63) Related by Continuation (CON) or Continuation-in-Part
`(CIP) to Earlier Application
`us
`Filed on
`
`09/369,048 (CTP)
`4 August 1999 (04.08.99)
`
`(71) Applicant (for all designated States except US): PERCARDIA,
`INC. [US/US); Suite 434, 20 T rafalgar Square, Nashua, NH
`03063 (US).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): PHELPS, David, Y.
`[US/US]; 904 Shady Lane, Louisville, KY 40223 (US).
`FURNISH, Greg, R. [US/US]; 2614 Top Hill Road,
`Louisville, KY 40206 (US). HALL, Todd, A. [US/US];
`
`(54) Title: TMR SHUNT
`
`(74) Agent.: ALTMAN, Daniel, E.; Knobbe, Martens, Olson & Bear,
`LLP, Sixteenth Floor, 620 Newport Center Drive, Newport
`Beach, CA 92660 (US).
`
`(81) Designated States: AE, AL, AM, AT, AU, AZ, BA, BB, BG,
`BR.BY, CA, CH, CN,CR,CU, CZ, DE, DK, DM, EE,
`ES, Fl, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP,
`KE, KG, KP,KR,KZ,LC, LK,LR, LS,LT,LU,LV,MD,
`MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD,
`SE, SG, SI, SK, SL, TJ, TM, TR, TI, UA, UG, US, UZ,
`VN, YU, ZA, ZW, ARIPO patent (GH, GM, KE, LS, MW,
`SD , SL, SZ, UG, ZW), Eurasian patent (AM, AZ, BY, KG,
`KZ, MD, RU, TJ, TM), European patent (AT, BE, CH, CY,
`DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT,
`SE), OAP! patent (BF, BJ, CF, CG, er. CM, GA, GN, GW,
`ML, MR, N_E, SN, TD, TG).
`
`Published
`With i111ernatio11al search report.
`Before the expiration of the time limit for amending the
`claims and to be republished in the event of the receipt of
`amendments.
`
`(57) Abstract
`
`A conduit is provided to provide a bypass around a blockage in the coronary artery. The conduit is adapted to be positioned in the
`myocardium or heart wall to provide a passage for blood to flow between a chamber of the heart such as the left ventricle and the coronary
`artery, distal to the blockage. The stem is self-expanding or uses a balloon to expand the stent in the heart wall. Various attachment means
`are provided to anchor the stent and prevent its migration. In one embodiment, a conduit is provided having a distal top which is more
`preferably a ball top, wire top, flare top or fli~own top. These top configurations anchor the shunt at one end in the coronary artery.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 1 of 80
`
`

`

`FOR THE PURPOSES OF INPORMATION ONLY
`
`Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.
`
`AL
`AM
`AT
`AU
`AZ
`DA
`BB
`BE
`BF
`BG
`BJ
`BR
`BY
`CA
`CF
`CG
`CH
`er
`CM
`CN
`cu
`CZ
`DE
`DK
`EE
`
`Albania
`Armenia
`Austria
`Australia
`A1.erbaijan
`Bosnia and Herzegovina
`Barbados
`Belgium
`Burkina f'aso
`Bulgaria
`Benin
`Brazil
`Belarus
`Canada
`Central African Republic
`Congo
`Switzerland
`COie d'Jvoire
`Cameroon
`China
`Cuba
`Czech Republic
`Gennany
`Denmark
`Estonia
`
`ES
`Fl
`FR
`GA
`GB
`GE
`GH
`GN
`GR
`HU
`IE
`IL
`IS
`IT
`JP
`KE
`KG
`KP
`
`KR
`K1,
`LC
`LI
`LK
`LR
`
`Spain
`f'inland
`France
`Gabon
`United Kingdom
`Georgia
`Ghana
`Guinea
`Greece
`Hungruy
`Ireland
`Israel
`Iceland
`Jraly
`Japan
`Kenya
`Kyrgyzstan
`Democratic People's
`Republic of Korea
`Republic of Korea
`Kazakstan
`Saint Lucia
`Liechtenstein
`Sri Lanka
`Liberia
`
`I..S
`LT
`LU
`LV
`MC
`MD
`MG
`MK
`
`Lesotho
`Lithuania
`Lwtembourg
`Lacvia
`Monaco
`Republic of Moldova
`Madagascar
`The fonner Yugoslav
`Republic of MOC'1donia
`Ml,
`Mali
`MN
`Mongolia
`MR
`Mauritania
`MW Malawi
`MX
`Mexico
`NE
`Niger
`NL
`Netherlands
`NO
`Norway
`NZ
`New Zealand
`PL
`Poland
`PT
`Ponugal
`RO
`Romania
`RU
`Russian Federation
`SD
`Sudan
`SE
`Sweden
`SG
`Singapore
`
`sr
`SK
`SN
`sz
`TD
`TG
`TJ
`TM
`TR
`TI
`UA
`UG
`us
`uz
`VN
`YU
`zw
`
`Slovenia
`Slovakia
`Senegal
`Swaziland
`Chad
`Togo
`Tajikistan
`Turkmenistan
`Turkey
`Trinidad and Tobago
`Ukraine
`Uganda
`United Stares of America
`Uzbekistan
`Viet Nam
`Yugoslavia
`Zimbabwe
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 2 of 80
`
`

`

`WO 00/15147
`
`PCT/US99/20714
`
`TMR SHUNT
`
`Field of the Invention
`
`The present invention relates to an apparatus for bypassing a blocked blood
`
`vessel segment, and, more particularly, to a conduit or stent positioned between the
`
`5
`
`coronary artery or other blocked vessel and a chamber of the heart, such as the left
`
`ventricle of the heart, to bypass a blocked segment of the coronary artery or other
`
`blood vessel.
`
`Background of the Invention
`
`Coronary artery disease is a major problem in the U.S. and throughout the
`
`10
`
`world. Coronary arteries as well as other blood vessels frequently become clogged
`
`with plaque, which at the very least impairs the efficiency of the heart's pumping
`
`action, and can lead to heart attack and death. In some cases, these arteries can be
`
`unblocked through non-invasive techniques such as balloon angioplasty.
`
`In more
`
`difficult cases, a bypass of the blocked vessel is necessary.
`
`15
`
`In a bypass operation, one or more venous segments are inserted between the
`
`aorta and the coronary artery. The inserted venous segments or transplants act as a
`
`bypass of the blocked portion of the coronary artery and thus provide for a free or
`
`unobstructed flow of blood to the heart. More than 500,000 bypass procedures are
`
`performed in the U.S. every year.
`
`20
`
`Such coronary artery bypass surgery, however, is a very intrusive procedure
`
`that is expensive, time-consuming and traumatic to the patient. The operation requires
`
`an incision through the patient's sternum (sternotomy), and that the patient be placed
`
`on a bypass pump so that the heart can be operated on while not beating. A vein graft
`
`is harvested from the patient's leg, another highly invasive procedure, and a delicate
`
`25
`
`surgical procedure is required to piece the bypass graft to the coronary artery
`
`(anastomosis). Hospital stays subsequent to the surgery and convalescence are
`
`prolonged.
`
`As mentioned above, another conventional
`
`treatment
`
`is percutaneous
`
`transluminal coronary angioplasty (PTCA) or other types of angioplasty. However,
`
`30
`
`such vascular treatments are not always indicated due to the type or location of the
`
`blockage, or due to the risk of emboli.
`
`Thus, there is a need for an improved bypass system which is less traumatic to
`the patient.
`
`Summary of the Invention
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 3 of 80
`
`

`

`WO 00/15147
`
`PCT /US99/20714
`
`The preferred embodiments of the present invention address the need in the
`
`previous technology by providing a bypass system that avoids the sternotomy and
`
`other intrusive procedures normally associated with coronary bypass surgery. These
`
`embodiments also free the surgeon from the multiple anastomoses necessary in the
`
`5
`
`current process.
`
`The preferred device provides a shunt for diverting blood directly from a
`
`chamber in the heart, such as the left ventricle, to the coronary artery, distal to the
`
`blockage, therefore bypassing the blocked portion of the vessel. The shunt
`
`comprises a stent or conduit adapted to be positioned in the heart wall or
`
`10
`
`myocardium between a chamber in the heart such as the left ventricle and the
`
`coronary artery that allows for the direct passage of blood therethrough. As used
`
`herein, the terms "stent" and "conduit" are interchangeable, and refer to a device that
`
`allows for the passage of blood therethrough. The terms "myocardium" and "heart
`
`wall" are also used interchangeably.
`
`In addition, although the left ventricle is
`
`15
`
`referred to throughout the description, it should be understood that the conduit
`
`described herein can be used to provide a passageway for the flow of blood from any
`
`heart chamber, not only the left ventricle.
`
`The stent device is delivered either externally or internally through the
`
`coronary artery to a position distal to the blockage. At that position, the coronary
`
`20
`
`artery, the myocardium and the wall of the left ventricle are pierced to provide a
`
`channel completely through from the coronary artery to the left ventricle of the
`
`heart. The stent is then positioned in the channel to provide a permanent passage for
`
`blood to flow between the left ventricle of the heart and the coronary artery, distal to
`
`the blockage. The stent is sized so that one open end is positioned within the
`
`25
`
`coronary artery, while the other open end is positioned in the left ventricle. The
`
`hollow lumen of the stent provides a passage for the flow of blood.
`
`The stent can be self-expandable or expanded by means of a balloon or
`
`similar device, and can be provided with various means to anchor it in position, such
`
`as expandable legs, hooks, barbs, flanges, collars, loops, wires, flares, suture holes
`
`30
`
`and the like. The anchoring means can be adapted to anchor the conduit in the heart
`
`wall, or alternatively, in the coronary artery. The stent can be formed from a
`
`plurality of rings, which can be connected to provide stability. The stent can include
`
`a valve in its interior, and can also be used to deliver drugs or other pharmaceutical
`
`compounds directly into the myocardium and the coronary circulation.
`
`2
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 4 of 80
`
`

`

`WO 00/15147
`
`PCT /US99/207 I 4
`
`Briefly stated, the methods and apparatus described and illustrated herein
`
`generally relate to direct coronary revascularization, wherein a conduit or opening is
`
`provided from the left ventricle to the coronary artery, oftentimes the left anter.ior
`
`descending (LAD), to provide blood flow directly therethrough. The conduit of the
`
`5
`
`preferred embodiments has a distal top which is more preferably a ball top, wire top,
`
`flare top or flip-down top. These top configurations anchor the shunt at one end in
`
`the coronary artery.
`
`Brief Description of the Drawings
`
`FIGURE IA is a cross-sectional view of a human heart, aorta and coronary
`
`10
`
`artery.
`
`FIGURE 1B is a side view of one embodiment of an expandable stent and
`
`the balloon catheter used for stent delivery.
`
`FIGURE 2 is a side view of the stent of FIGURE 1B mounted on the distal
`
`end of the catheter for delivery into the myocardium, with the coronary artery and
`
`15
`
`myocardium shown cut-away.
`
`FIGURE 3 is a side view of the distal end of the stent/catheter assembly of
`
`FIGURE 1B positioned in the myocardium, with the coronary artery and
`
`myocardium shown cut-away.
`
`FIGURE 4 is a cross-sectional side view of the stent of FIGURE 1B
`
`20
`
`positioned within the myocardium after removal of the catheter used for delivery.
`FIGURE 5 is a side view of another embodiment of the stent and the
`
`catheter used for stent delivery.
`
`FIGURE 6 is a cross-sectional side view of the catheter and puncture device
`
`used to introduce the self-expanding stent of FIGURE 5 into the myocardium.
`
`25
`
`FIGURE 7 is a cross-sectional side view of the stent/catheter assembly of
`
`FIGURE 5 positioned in the myocardium.
`
`FIGURE 8 is a side view of the self-expanding stent of FIGURE 5
`
`positioned within the myocardium after removal of the catheter and puncture device,
`
`with the coronary artery and myocardium shown cut-away.
`
`30
`
`FIGURE 9 is a perspective view of another embodiment of the stent having
`
`expandable legs, showing the stent mounted on the distal end of the introducer
`
`catheter.
`
`FIGURE 10 is a perspective view of the stent of FIGURE 9, showing the
`
`distal end of the introducer catheter pushed forward to allow the legs of the stent to
`
`35
`
`expand.
`
`3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 5 of 80
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`

`

`WO 00/15147
`
`PCT/US99/20714
`
`FIGURE 11 is a perspective view of the stent of FIGURE 9, showing the
`
`legs of the stent in an expanded position.
`FIGURE 12 is a side view of another embodiment of the stent positioned
`
`within the myocardium, with the coronary artery and myocardium shown cut-away.
`
`5
`
`FIGURE 13 is a side view of a biodegradable stent positioned within the
`
`myocardium, with the coronary artery and myocardium shown cut-away.
`
`FIGURE 14 is a side view of a catheter and puncture device used to
`
`introduce a bulkhead stent into the myocardium, with the coronary artery and
`
`myocardium shown cut-away.
`FIGURE 15 is a side view _of the stent/catheter assembly of FIGURE 14
`
`IO
`
`positioned in the myocardium, with the coronary artery and myocardium shown cut(cid:173)
`
`away.
`
`FIGURES 16-19 are progressive side views of the stent/catheter assembly of
`
`FIGURE 14, showing the bulkhead stent being deployed into the myocardium.
`
`15
`
`FIGURES 20 and 21 are enlarged views of FIGURES 18 and 19,
`
`respectively, showing the bulkhead stent being deployed into the myocardium.
`FIGURE 22 is a perspective view of a ring of a bulkhead stent in a loaded
`
`configuration
`FIGURE 23 is a perspective view of a ring of a bulkhead stent in an inserted
`
`20
`
`configuration.
`FIGURE 24 is a perspective view of a bulkhead stent within a delivery
`
`catheter, showing the rings of the bulkhead stent being inserted.
`FIGURE 25 is a perspective view of a bulkhead stent, with the rings of the
`
`stent in loaded and inserted configurations.
`
`25
`
`FIGURE 26 is a perspective view of an inserter device used to insert a
`
`bulkhead stent.
`FIGURE 27 A is a schematic, cross-sectional view of the human heart,
`
`showing a catheter used to form a channel through the myocardium and into the left
`
`ventricle inserted into the coronary artery.
`FIGURE 27B is an enlarged view of the distal end of the catheter and the
`
`30
`
`channel through the myocardium in FIGURE 27 A.
`
`FIGURE 28 is a schematic, cross-sectional view of a stent delivery catheter
`
`positioned inside the channel formed in the myocardium.
`FIGURE 29 is a schematic, partial cross-sectional view of a self-expanding
`
`35
`
`spring stent being positioned in the channel formed in the myocardium.
`
`4
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 6 of 80
`
`

`

`WO 00/15147
`FIGURE 30 is a schematic, partial cross-sectional view of the self(cid:173)
`
`PCT/US99/20714
`
`expanding stent deployed within the myocardium.
`FIGURE 31 is a perspective view of another embodiment of a stent having
`
`retention members which maintain the position of the stent.
`FIGURE 32 is a schematic, cross-sectional view of a human heart, showing a
`
`conduit in the myocardium of the heart for forming a bypass shunt between the left
`
`ventricle and a coronary artery.
`FIGURE 33A is a side view of a wire top shunt according to one
`
`embodiment of the present invention.
`FIGURE 33B is a side view of a wire top shunt according to another
`
`embodiment of the present invention.
`FIGURES 33C-33F are schematic side views of wire top shunts inserted
`
`into a patient' s coronary artery.
`FIGURES 33G-33I are schematic side views of a delivery sequence for
`
`inserting a wire top shunt.
`FIGURE 34A is a side view of a wire top shunt according to another
`
`embodiment of the present invention.
`FIGURE 34B is a side view of a ball top shunt according to one
`
`5
`
`1 0
`
`15
`
`embodiment of the present invention, the shunt being shown laid out flat.
`FIGURE 34C is a side view of the ball top shunt of FIGURE 34B, shown
`
`20
`
`implanted in a patient.
`FIGURE 34D is a side view of a ball top shunt according to another
`
`embodiment of the present invention, the shunt being shown laid out flat.
`FIGURE 34E is a side view of a ball top shunt according to another
`
`25
`
`embodiment of the present invention, the shunt being shown in its preassembly
`
`configuration.
`FIGURE 34F is a side view of a ball top shunt according to another
`
`embodiment of the present invention, the shunt being shown laid out flat.
`FIGURE 34G is a side view of the ball top shunt of FIGURE 34F, shown
`
`30
`
`implanted in a patient.
`FIGURE 34B is a side view of a ball top shunt according to another
`
`embodiment of the present invention, the shunt being shown laid out flat.
`FIGURE 341 is a side view of a ball top shunt according to another
`
`embodiment of the present invention, the shunt being shown laid out flat.
`
`5
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 7 of 80
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`

`

`WO 00/15147
`
`PCT/US99/207I4
`
`FIGURE 34J is a side view of a ball top shunt according to another
`
`embodiment of the present invention, the shunt being shown laid out flat.
`
`FIGURE 34K is a side view of a flexible ball top shunt.
`
`FIGURE 34L is a side view of the delivery apparatus for the ball top shunt
`
`5
`
`of FIGURE 34K
`FIGURE 35 is a side view of a wire top shunt according to another
`
`embodiment of the present invention.
`FIGURE 36 is an enlarged view of the wire top shunt of FIGURE 35.
`
`FIGURE 37 is a side view of a wire top shunt according to another
`
`10
`
`embodiment of the present invention.
`
`FIGURE 38 is a top view of the wire top shunt of FIGURE 37.
`
`FIGURES 39A-39F are side views showing the deployment sequence of a
`
`wire top shunt.
`
`FIGURE 40A is a side view of a flare top shunt according to one
`
`15
`
`embodiment of the present invention.
`
`FIGURE 40B is a side view of a flip-down shunt according to one
`
`embodiment of the present invention, the shunt being shown laid out flat.
`
`FIGURE 40C is a side view of the flip-down shunt of FIGURE 40B, shown
`
`implanted in a patient.
`
`20
`
`FIGURE 41 is a side view of a shunt with a T-flange.
`
`FIGURE 42 is a schematic view of a hinged conduit.
`
`FIGURE 43 is a schematic view of another embodiment of a hinged conduit.
`
`FIGURE 44A is a schematic side view of a bell shape stent having a web
`
`flange and an axially expandable region.
`
`25
`
`FIGURE 44B is a schematic side view of the distal end of the stent of
`
`FIGURE 44A showing more particularly the web flange in the coronary artery.
`
`FIGURE 44C is a schematic side view of the stent and web flange of
`FIGURE 44A showing a stylet holding the web flange closed.
`
`FIGURE 46 is a schematic side view of a conduit having annular grooves.
`
`30
`
`FIGURE 47A is a schematic side view of a conduit having a single loop
`
`anchoring mechanism.
`
`FIGURE 47B is a front view of the conduit of FIGURE 47A.
`
`FIGURE 48A is a side view of a conduit having deployable flanges.
`
`FIGURE 48B illustrates the conduit of FIGURE 48A with the flanges
`
`35
`
`deployed.
`
`6
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 8 of 80
`
`

`

`WO 00/15147
`
`PCT/US99/20714
`
`Detailed Description of the Preferred Embodiment
`
`As is well known, the coronary artery branches off the aorta and is
`
`positioned along the external surface of the heart wall. The anatomy of the human
`
`heart is illustrated in FIGURE lA. Oxygenated blood flows from the heart PH to
`
`5
`
`the aorta AO, on to the rest of the body, some of the blood flowing into the coronary
`
`artery CA. In some individuals, plaque builds up within the coronary artery CA,
`
`blocking the free flow of blood and causing complications ranging from mild angina
`
`to heart attack and death.
`
`In order to restore the flow of oxygenated blood through the coronary artery,
`
`1 O
`
`one embodiment of the present invention provides for the shunting of blood directly
`
`from the heart to a site in the coronary artery that is distal to the blockage. A
`
`channel is formed through the wall of the coronary artery and the myocardium and
`
`into the left ventricle of the heart that lies beneath the coronary artery. A stent or
`
`conduit is positioned in the passage to keep it open, and allow for the flow of
`
`15
`
`oxygenated blood directly from the heart into the coronary artery. Again, it should
`
`be understood that while the insertion of the conduit in the myocardium between the
`
`left ventricle and the coronary artery is described in detail below, this is merely
`
`exemplary and use of the conduit between other chambers of the heart and the
`
`coronary artery, and between blood vessels is also contemplated.
`
`20
`
`The principles of the present invention are not limited to left ventricular
`
`conduits, and include conduits for communicating bodily fluids from any space
`
`within a patient to another space within a patient, including any mammal.
`
`Furthermore, such fluid communication through the conduits is not limited to any
`
`particular direction of flow and can be antegrade or retrograde with respect to the
`
`25
`
`normal flow of fluid. Moreover, the conduits may communicate between a bodily
`
`space and a vessel or from one vessel to another vessel (such as an artery to a vein or
`
`vice versa). Moreover, the conduits can reside in a single bodily space so as to
`
`communicate fluids from one portion of the space to another. For example, the
`
`conduits can be used to achieve a bypass within a single vessel, such as
`
`30
`
`communicating blood from a proximal portion of an occluded coronary artery to a
`
`more distal portion of that same coronary artery.
`
`In addition, the conduits and related methods can preferably traverse various
`
`intermediate destinations and are not limited to any particular flow sequence. For
`
`example, in one preferred embodiment of the present invention, the conduit
`
`35
`
`communicates from the left ventricle, through the myocardium, into the pericardia!
`
`7
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 9 of 80
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`

`

`WO 00/15147
`
`PCT/US99/20714
`
`space, and then into the coronary artery. However, other preferred embodiments are
`
`disclosed, including direct transmyocardiaJ communication from a left ventricle,
`
`through the myocardium and into the coronary artery. Thus, as emphasized above,
`
`the term "transmyocardial" should not be narrowly construed in connection with the
`
`5
`
`preferred fluid communication conduits, and other non-myocardial and even non(cid:173)
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`cardiac fluid communication are preferred as well. With respect to the walls of the
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`heart (and more specificaJly the term "heart wall"), the preferred conduits and
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`related methods are capable of flu id communication through all such walls
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`including, without
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`limitation,
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`the pericardium,
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`epicardium, myocardium,
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`J 0
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`endocardium, septum, etc.
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`The bypass which is achieved with certain preferred embodiments and
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`related methods is not limited to a complete bypass of bodily fluid flow, but can also
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`include a partial bypass which advantageously supplements the normaJ bodily blood
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`flow. Moreover, the occlusions which are bypassed may be of a partial or complete
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`15
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`nature, and therefore the terminology "bypass" or "occlusion" should not be
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`construed to be limited to a complete bypass or a complete occlusion but can include
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`partial bypass and partial occlusion as described.
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`The preferred conduits and related methods disclosed herein can also provide
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`complete passages or partial passages through bodily tissues.
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`In this regard, the
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`20
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`conduits can comprise stents, shunts, or the like, and therefore provide a passageway
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`or opening for bodily fluid such as blood. Moreover, the conduits are not
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`necessarily stented or lined with a device but can comprise mere tunnels or openings
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`formed in the tissues of the patient.
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`The conduits of the present invention preferably comprise both integral or
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`25
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`one-piece conduits as well as plural sections joined together to form a continuous
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`conduit. The present conduits can be deployed in a variety of methods consistent
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`with sound medical practice including vascular or surgical deliveries, including
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`minimally invasive techniques. For example, various preferred embodiments of
`delivery rods and associated methods may be used. In one embodiment, the delivery
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`30
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`rod is solid and trocar-like. It may be rigid or semi-rigid and capable of penetrating
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`the tissues of the patient and thereby form the conduit, in whole or in part, for
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`purposes of fluid communication. In other preferred embodiments, the delivery rods
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`may be hollow so as to form the conduits themselves (e.g., the conduits are
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`preferably self-implanting or self-inserting) or have a conduit mounted thereon (e.g.,
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`35
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`the delivery rod is preferably withdrawn leaving the conduit installed). Thus, the
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`8
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`preferred conduit device and method for installation is preferably determined by
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`appropriate patient indications in accordance with sound medical practices.
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`In some individuals, aortic insufficiency or peripheral venous insufficiency
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`occurs. Aortic insufficiency is the leakage of blood through the aortic valve,
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`5
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`resulting in a backflow of blood into the left ventricle. The heart compensates for
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`the backflow of blood by pumping harder, resulting in hypertrophy (thickening of
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`the heart muscle) and dilation of the left ventricle wal I. Left untreated, heart failure
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`can result.
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`In venous insufficiency, the heart valves are unable to prevent the
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`backflow of blood. This too can result in heart failure. Accordingly, one
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`10
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`embodiment of the invention provides for the use of a conduit placed within the
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`heart wall to improve the flow of oxygenated blood through the body.
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`Balloon Expanded Stent
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`A first embodiment of the present invention is illustrated in FIGURE lB.
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`This embodiment is a balloon-expanded stent IO. The stent IO is introduced as
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`15
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`described below, using a high-pressure balloon catheter 12 to deploy the stent I 0
`once it is properly positioned in the myocardium MYO (FIGURE 2). When the
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`stent 10 is positioned inside the myocardial wall MYO, the balloon 14 is inflated to
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`expand the stent IO and open the conduit from the left ventricle L V into the coronary
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`artery CA The stent IO can include attachment mechanisms not limited to hooks,
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`20
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`barbs, flanges, large collars, suture holes and/or other means to ensure a seal is
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`created between the coronary artery CA and the wall of the myocardium MYO and
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`to prevent the threat of stent IO migration. When the attachment of the stent 10 is
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`completed, the remaining catheter assembly 12 is removed, leaving the stent IO in
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`place. Upon deflating the balloon 14, the stent 10 will remain open. Because of the
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`25
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`shape of this stent 10, a dumbbell shaped balloon 14 is preferably used to ensure
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`proper expansion, as described below.
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`FIGURES l B through 4 illustrate the introduction of the balloon-expanded
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`stent IO into the myocardial wall MYO. FIGURE lB illustrates the stent 10
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`mounted over the balloon 14 on the distal end of the stent introducer catheter 12.
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`30
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`FIGURE 2 illustrates the stent introducer catheter 12 following the path created by
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`a puncture wire 16 extending past the distal end of the introducer catheter 12, and
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`used to access the left ventricle L V through the coronary artery CA and myocardium
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`MYO.
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`FIGURE 3 mustrates the non-expanded stent 10 positioned inside the
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`35
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`myocardial wall MYO prior to inflation of the balloon 14. FIGURE 4 illustrates an
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`9
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`expanded stent IO in position, with the introducer catheter 12 removed. Because of
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`the way the attachment mechanisms 18 expand on this stent IO, a dumbbell shaped
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`balloon 14 is preferably used to flare out the ends of the stent IO. These flared edges
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`18 maintain the stent l 0 in its proper position in the heart wall MYO and provide a
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`5
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`seal between the coronary artery CA and the outer heart waH MYO.
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`Self Expanding Stent
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`The second embodiment of the stent or conduit incorporates a self-expanding
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`stent 20, illustrated in FIGURES 5-8. The stent 20, having a retaining sheath 26 to
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`hold it in a non-expanded configuration, is introduced into the wall of the
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`IO
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`myocardium MYO as follows. The stent delivery catheter 22 is advanced over a
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`puncture mechanism 24 and into the wall of the myocardium MYO as described
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`above. When the stent 20 is properly seated in the myocardial wall MYO, its
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`retaining sheath 26 is withdrawn, allowing the stent 20 to expand and open a conduit
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`from the ventricle L V to the coronary artery CA. This stent 20 also includes
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`15
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`attachment mechanisms not limited to books, barbs, flanges, large collars, suture
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`holes and/or other means to ensure a seal is created between the artery CA and the
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`wall of the myocardium MYO, and to prevent the threat of stent 20 migration.
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`When the positioning is completed, the remaining catheter assembly 22 is removed,
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`leaving the stent 20 in place.
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`20
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`The self-expanding stent 20 mounted on the distal end of the stent introducer
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`catheter 22 is illustrated in FIGURE 5. FIGURE 6 illustrates the stent introducer
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`22 following the path created by a puncture wire 24 used to form the passage
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`between the coronary artery CA and the left ventricle L V. FIGURE 7 illustrates a
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`non-expanded stent 20 located in position on the stent introducer catheter 22 with
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`25
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`the introducer catheter 22 in position in the heart wall MYO. FIGURE 8 illustrates
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`the self-expanding stent 20 in position, with the introducing catheter 22 removed.
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`Flared edges 28 on the stent 20 maintain its proper position in the heart wall MYO
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`and provide a seal between the coronary vessel CA and outer sunace of the heart
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`MYO.
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`30
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`For the stent designs described above, additional anchoring methods may be
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`desired to maintain the stent's proper position and/or create a leak-free seal in the
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`coronary artery. Suitable attachment mechanisms include a set of barbs located on
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`the stent body or flares and a collar on the coronary side to help seal and prevent
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`blood from exiting the gap between the vessel and outer heart wall. The stent can
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`3 5
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`also be anchored in place by applying sutures. The stent can include holes at either
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`end to facilitate the placement of these anchoring sutures. A suture gun can be used
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`to apply multiple sutures at the same time. In addition, the stents can be lined, if
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`desired, with materials such as polymers, for example polytetrafluoroethylene
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`(PTFE), silicone or GORTEX, to provide for the ease of blood flow therethrough.
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`5
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`Stent with Attachment Flanges
`A third embodiment of the stent design, illustrated in FIGURES 9-11,
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`incorporates attachment flanges or "legs" 30 that expand after introduction into the
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`myocardium to hold the stent 34 in place. The puncture instrument 32 and stent 34
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`are mated together and are advanced into the myocardial wall as a single unit. The
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`10
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`puncture instrument' s distal end 36 is shaped in a "nose-cone" configuration, which
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`is responsible for containing the legs 30 of the stent 34 while it is being introduced
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`into the wall of the myocardium. When the stent 34 is in the proper position in the
`
`myocardial wall, the nose cone 36 is pushed forward, releasing the attachment legs
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`30 of the stent 34. The internal diameter (ID) of the stent 34 is large enough to
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`15
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`allow the nose cone 36 to pass back through. The stent 34 is then released from the
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`catheter 38 and the catheter 38 is removed.
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`FIGURE 9 illustrates the stent 34 mounted on the introducer catheter 38.
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`The expanding legs 30 of the stent 34 are held in place by the nose cone 36 on the
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`distal end of the catheter 38 that acts as a dilator. The catheter assembly 38 is
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`20
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`advanced over a puncture wire if desired, into proper position in the myocardium,
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`and the nose cone 36 is pushed forward allowing the legs 30 to expand as shown in
`FIGURE 10. The nose-cone/puncture assembly 32, 36 is then withdrawn through
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`the l