(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2001/0002445 A1
`Vesely
`(43) Pub. Date:
`May 31, 2001
`
`US 20010002445A1
`
`(54) BIOPROSTHETIC CARDIOVASCULAR
`
`Related US. Application Data
`
`VALVE SYSTEM
`
`75
`
`(
`
`~
`
`) Inventor' Ivan vesely’ Cleveland Helghts’ OH
`(Us)
`
`'
`
`.
`
`.
`
`.
`
`.
`
`.
`
`(63) Continuation-m-part of application No. 09/597,918,
`?led on Jun. 19, 2000, Which is a continuation of
`application No. PCT/US98/27481, ?led on Dec. 23,
`1998 and Which is a non-provisional of provisional
`application No. 60/068,711, ?led on Dec. 29, 1997.
`
`Correspondence Address:
`ARTER & HADDEN, LLP
`1100 HUNTINGTON BUILDING
`925 EUCLID AVENUE
`CLEVELAND, OH 44115-1475 (US)
`
`(73) Assignee; The Cleveland Clinic FOllIldatiOIl
`
`(21) Appl- NO-I
`
`09/745,240
`
`(22) Filed:
`
`DEC. 21, 2000
`
`Publication Classi?cation
`
`(51) Int. c1.7 ...................................................... ..A61F 2/24
`(52) us. Cl. .................... .. 623/211; 623/212, 623/238;
`623/900; 623/904
`
`ABSTRACT
`(57)
`A cardiovascular valve system including a permanent base
`unit that is affixed to the patient using conventional sutures
`or staples, and a collapsible valve having a collapsible frame
`that mates With the permanent base unit, and supports valve
`lea?ets. An installed collapsible frame may be re-collapsed
`and disengaged from the permanent housing. A neW col
`lapsible valve is then installed, to resume the function of the
`prosthesis_
`
`1__09.
`
`112
`
`114
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`NORRED EXHIBIT 2111 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
`
`

`
`Patent Application Publication May 31, 2001
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`Fig.1
`(PRIOR ART)
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`58
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`llllllllllllllllllll Lllli
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`Fig. 8B
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`llllllllllllllllllll llll
`/,
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`Patent Application Publication May 31, 2001
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`, //v 4 6 mm W WW, / @ dxv 7x
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`E .5
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`103 é % 102
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`

`
`US 2001/0002445 A1
`
`May 31, 2001
`
`BIOPROSTHETIC CARDIOVASCULAR VALVE
`SYSTEM
`
`RELATED APPLICATION
`
`[0001] This is a continuation-in-part of U.S. application
`Ser. No. 09/597,918, which is a continuation of International
`Application PCT/U.S. Pat. No. 98/27,481, with an interna-
`tional filing date of Dec. 23, 1998, which claims the benefit
`of U.S. Provisional Application No. 60/068,711 filed Dec.
`29, 1997.
`
`BACKGROUND OF THE INVENTION
`
`[0002] The current practice of inserting artificial heart
`valves involves cutting the chest open, placing the patient on
`cardiopulmonary bypass, and surgically inserting the valve
`into an aorta. This process can take several hours and
`subjects the patient to significant operative mortality. While
`the mortality during first valve replacement surgery can be
`very low (less than 5%), the second surgery carries much
`greater operative mortality, and the third is even more risky
`(>15%). Consequently, first and second re-operations to
`replace a worn out bioprosthetic heart valve are avoided.
`Since a typical bioprosthesis, or tissue valve, can wear out
`in 10 years, these valves are typically implanted into patients
`60 years old, or older. Younger patients are often recom-
`mended a mechanical valve that does not wear out, and
`typically does not need replacement.
`
`[0003] Tissue valves, however, are often preferred over
`mechanical valves because of their better biocompatibility.
`Mechanical valves cause blood to clot on their components,
`and the patient must therefore be chronically treated with
`anticoagulants to eliminate the risk of major blood clots.
`Anticoagulant themselves, however, carry a measurable risk
`of bleeding and thromboembolism and are not an ideal
`solution. Because tissue valves do not need to be antico-
`
`agulated, they are potentially the ideal valve prosthesis, if
`only their durability were to be improved.
`
`[0004] Accordingly, the goal of most tissue valve research
`and development, has been the improvement in valve dura-
`bility so that these tissue valves can be put into patients
`younger than 60 or 65. Because of the operative mortality
`and morbidity,
`the objectives of all valve research and
`development, has been to increase the functional life span of
`the bioprosthesis so that it can be put into patients only once,
`and will last the life of the patient. This has thus far been an
`extremely difficult goal to reach.
`
`[0005] There may be another option, however, for the use
`of tissue heart valves in the younger population. Rather than
`building valves that last longer, it may be more appropriate
`to build valves that can be routinely replaced in a way that
`induces negligible patient morbidity. The objectives would
`therefore be not to have extremely durable valves, but rather
`valves that can be easily removed when they begin to fail
`and new ones inserted. The technologies that make this
`possible already exist with the advances made in the field of
`catheter-based endovascular procedures, and the more broad
`field of Minimally Invasive Surgery (MIS).
`
`[0006] The field of MIS is growing at an accelerating pace.
`The approach involves the use of small surgical probes,
`cannulas, video cameras and remote staplers and suture
`drivers that enable surgery to be done without requiring
`
`large incisions. Most MIS is done with several small inci-
`sions, simply to allow the passage of these instruments into
`the patients body. The principal advantages of MIS is that
`the patient is subjected to less surgical trauma and has a
`dramatically reduced hospital stay, which in turn signifi-
`cantly reduces the operating costs of the clinical center.
`Current generation minimally invasive procedures are being
`carried out using endoscopes and long-reaching surgical
`tools. Typically,
`the patient’s abdomen is inflated with
`carbon dioxide and the instruments are inserted through
`small incisions. The surgeons then perform the procedures
`using endoscopic visualization. For cardiothoracic surgery,
`similar small incisions are created between the ribs and the
`
`is placed on bypass using multiple cannulas with
`heart
`balloons that can selectively shut off blood flow through the
`heart, and direct it through oxygenators.
`
`[0007] Other technologies are being developed to do sur-
`gery on beating hearts, as to completely avoid placing the
`heart on bypass. Many of these procedures involve the use
`of specialized catheters that deploy devices or tools that
`perform a wide range of procedures on the beating heart.
`Typical beating heart procedures are endovascular balloon
`dilatation of arteries and stent placement. Deployment of
`stents and other permanent devices has become common-
`place, but to date, no successful, catheter deployable valve
`has been developed.
`
`[0008] While U.S. Pat. No. 5,545,214 discloses a balloon-
`deployable tissue valve, the technology is similar to that of
`stents, and is not ideal for tissue heart valves. The material
`that anchors the valve in the patient’s aortic root is perma-
`nently deformed through the bending of metal components,
`and is not
`intended to be re-collapsed into its original
`configuration. Practically the same approach is disclosed in
`U.S. Pat. No. 5,411,552. U.S. Pat. No. 5,554,185 discloses
`a means of deploying the valve by inflating of a hollow valve
`frame with a liquid that hardens. U.S. Pat. No. 5,545,209
`describes the use of balloon technology to permanently
`distend and deploy an endoprosthesis, typically a vascular
`segment
`for
`treating abdominal aneurysm. This patent
`makes reference to “a tubular prosthesis disposed on said
`catheter over at least a portion of said balloon.” U.S. Pat. No.
`5,855,601 describes a prosthetic valve aflixed to a wire form
`that is self expanding, and has a plurality of barbs to anchor
`the stent in the aorta. The stent itself is of a continuous wire
`
`with a zigzag configuration, similar to the endoprostheses
`described above.
`
`[0009] The major concepts disclosed by the above-men-
`tioned patents are similar: the permanent deployment of a
`bioprosthetic heart valve. A permanently deployed tissue
`heart valve, whether it is done using MIS technology or not,
`is subject to the same requirements as conventional tissue
`valves: it must be very durable. Good durability, however, is
`not easily attained. The manufacturing process of tissue
`heart valves is very mature and complex from the quality
`control point of view, and only minimal improvements in
`valve durability have been achieved in recent years. Major
`improvements in valve durability are therefore not expected
`in the near future.
`
`invention addresses the drawbacks
`[0010] The present
`discussed above, as well as other problems encountered with
`the prior art, to provide a bioprosthetic cardiovascular valve
`system, wherein a valve can be inserted, removed, and
`re-inserted using minimally invasive surgical techniques.
`
`NORRED EXHIBIT 2111 - Page 26
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`

`
`US 2001/0002445 A1
`
`May 31, 2001
`
`SUMMARY OF THE INVENTION
`
`[0011] According to one aspect of the present invention
`there is provided a system for minimally invasive removal
`and re-insertion of a bioprosthetic cardiovascular valve.
`Preferably, the valve is sufficiently collapsible so as to be
`able to pass through the lumen of a catheter inserted into the
`femoral artery, or other large vessel. The collapsed valve is
`re-expanded when in place in order to fit into a permanent
`housing or base unit in the patients heart and assumes a fully
`functioning state. Integral to this system of removal and
`replacement of a prosthetic valve is an expandable “opera-
`tive platform” that is deployed near the site of the valve so
`that it stabilizes the catheters and other instruments during
`the valve removal and reinsertion process.
`
`In accordance with another aspect of the present
`[0012]
`invention, there is provided a cardiovascular valve system
`comprised of a permanent housing or base unit which
`remains in the patient, and a collapsible valve that engages
`with the permanent housing, and which is replaceable.
`
`In accordance with a further aspect of the present
`[0013]
`invention, there is provided a permanent housing or base
`unit taking the form of a non-collapsible permanent frame
`which acts as a receptacle for the collapsible valve. The
`permanent frame includes an integrated sewing ring which
`is aflixed to the patient’s aorta or other tissue by means of
`sutures or staples.
`
`In accordance with another aspect of the present
`[0014]
`invention,
`there is provided a collapsible cardiovascular
`valve including a collapsible frame onto which several
`leaflets or flexible occluders are aflixed, comprised of sev-
`eral articulating or hinged components which have a sub-
`stantially smaller perimeter when fully collapsed, than when
`fully expanded.
`
`In accordance with still another aspect of the
`[0015]
`present invention, there is provided an inflatable or disten-
`sible “surgical platform” which can be delivered to a site
`near the heart in a collapsed state and distended at that site
`such that it anchors the numerous catheters and devices in
`
`space thereby ensuring proper controlled manipulation of
`their distal ends, when acted upon by controls at
`their
`proximal ends.
`
`In accordance with still another aspect of the
`[0016]
`present invention,
`there is provided an integrated check
`valve within the surgical platform that enables controlled
`ejection of blood from the ventricle during the process of
`collapsible valve removal and replacement.
`
`In accordance with still another aspect of the
`[0017]
`invention,
`there is provided an integrated filter
`present
`within the surgical platform that enables the capture of any
`particulates that may be released during the process of
`collapsible valve removal and replacement.
`
`In accordance with yet another aspect of the
`[0018]
`present invention, there is provided a split wall or “mono-
`rail” catheter system which can guide larger instruments and
`devices between the outside of the patient and the surgical
`platform during the course of a valve replacement proce-
`dure.
`
`In accordance with yet another aspect of the
`[0019]
`present invention, there is provided a tracking and visual-
`ization system that can generate accurate images or graphi-
`
`cal representation of the catheters and other components on
`a computer screen so as to accurately represent the position
`of the real components inside the body of the patient.
`
`[0020] Although the bioprosthetic collapsible valve of the
`present invention may incorporate various number of leaf-
`lets, a preferred embodiment of the valve incorporates three
`(3) valve leaflets.
`
`[0021] Although the collapsible valve of the present
`invention may incorporate a wide range of leaflet materials,
`such as synthetic leaflets or those constructed from animal
`tissues, a preferred embodiment of the valve incorporates
`three (3) valve leaflets constructed from sheets of chemically
`preserved bovine pericardium.
`
`frame
`[0022] Although the non-collapsible permanent
`may be constructed from a wide range of materials including
`metals and plastics, a preferred embodiment of the perma-
`nent frame is constructed from a generally stiff, rigid mate-
`rial such as stainless steel, or a polymer.
`
`[0023] Although the collapsing mechanism of the collaps-
`ible frame may incorporate various means of remaining
`expanded within the permanent frame of the housing or base
`unit, one preferred embodiment of maintaining the collaps-
`ible frame of the collapsible valve in its expanded state is by
`means of “snapping” the collapsible frame into slots or clips
`and/or around protrusions during the expansion process. The
`collapsible frame is therefore held in an expanded position
`by means of an interference fit between components.
`
`[0024] Although the collapsible valve of the present
`invention may be expanded by various means, a preferred
`embodiment of the valve expanding means incorporates an
`articulating expanding means that does not require the use of
`balloon technology to expand the collapsible frame.
`
`[0025] Although the collapsible frame of the present
`invention may be collapsed by various means, one embodi-
`ment of the valve collapsing means involves expansion
`beyond its resting configuration, thus unsnapping it from the
`permanent
`frame, using a catheter-based manipulation
`means or hand-held tools.
`
`[0026] Although the present invention may make use of
`numerous means of stabilizing the proximal ends of the
`catheters, a preferred embodiment of the procedure is the use
`of a stabilizing surgical platform that can be anchored distal
`to the aortic valve. The surgical platform incorporates slots
`and fixtures for attaching and holding catheters in slots that
`stabilize the movement and position of the distal ends of the
`catheters so that deflection and manipulation of the catheter
`ends is done in a controlled way.
`
`[0027] Although the present invention may make use of
`numerous means of temporarily augmenting the action of
`the contracting heart by means of valves, a preferred
`embodiment of the procedure is the incorporation of an
`integrated check valve within the surgical platform that
`becomes functional once the platform is expanded in place.
`The integrated check valve can be fabricated out of polymer
`and have one or more occluding leaflets. The leaflets are soft
`and pliable and enable the passage of catheters and other
`devices past and through the leaflets. The surgical platform
`itself can be partially deflated during the valve replacement
`procedure in order to allow catheters to slide past it
`to
`remove or deliver a collapsed valve. The surgical platform
`
`NORRED EXHIBIT 2111 - Page 27
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`

`
`US 2001/0002445 A1
`
`May 31, 2001
`
`may also incorporate an integral sieve or screen to capture
`and hold any particulates that may be liberated during a
`valve replacement procedure. The surgical platform may
`also incorporate an optical, ultrasound, radiographic, mag-
`netic imaging head, or the like, so that close-up detailed
`images may be obtained during the valve replacement
`procedure.
`
`[0028] Although the present invention may make use of
`numerous catheters to deliver the components of the col-
`lapsible valve system into the desired site, one embodiment
`of the procedure is the use of multiple catheters and sheaths
`small enough to be inserted into the femoral artery without
`exposing the femoral artery to perform a “cut-down”.
`
`[0029] Although the present invention may make use of
`numerous imaging or localization techniques, one preferred
`embodiment of the procedure is the use of a ultrasonic or
`electromagnetic sensors affixed to the catheters and compo-
`nents such that their position can be detected and tracked in
`3-D space, in suflicient spatial and temporal resolution and
`precision, so as to make the procedure easy and accurate.
`Another visualization technique is bi-plane radiography or
`intra-cardiac echocardiography.
`
`[0030] As can be seen by those skilled in the art, an
`advantage of the present invention is the provision of a valve
`system that allows for safe and convenient removal and
`replacement of a collapsible valve when it begins to fail.
`
`[0031] Another advantage of the present invention is the
`provision of an expandable, re-collapsible tissue-based car-
`diovascular valve.
`
`[0032] Another advantage of the present invention is the
`provision of an expandable, re-collapsible valve that is small
`enough to be delivered by catheters by way of a percutane-
`ous puncture.
`
`[0033] Another advantage of the present invention is the
`replacement of a re-collapsible valve by way of conven-
`tional or minimally invasive cardiac surgery.
`
`[0034] Still another advantage of the present invention is
`the provision of a catheter-based valve delivery system.
`
`[0035] Still another advantage of the present invention is
`the provision of a valve delivery system consisting of
`surgical tools that can remove and deliver a re-collapsible
`valve by way of small incisions in the blood vessels that
`emerge from the heart, or in the wall of the heart itself.
`
`[0036] Still another advantage of the present invention is
`the provision of a stable surgical platform within which
`catheter-based manipulators can be securely anchored so
`that intracardiac procedures can be properly executed.
`
`[0037] Yet another advantage of the present invention is
`the provision of a synthetic valve integrated with the surgical
`platform to act as a temporary check valve while the
`expandable, re-collapsible tissue-based cardiovascular valve
`is being replaced.
`
`[0038] Yet another advantage of the present invention is
`the provision of a mesh integrated with the surgical platform
`to act as a sieve that captures any particulates that may be
`liberated during the valve replacement procedure.
`
`[0039] Yet another advantage of the present invention is
`the provision of a slotted catheter sheath that can act as a
`
`“monorail” guide to shuttle components along the outside of
`the sheath between the exit/entry port of the patient and the
`surgical platform within the heart.
`
`[0040] Yet another advantage of the present invention is
`the provision of a ultrasound or electromagnetic catheter
`guidance system that can track the position and motion of
`the catheters and devices during the procedure and display
`images of the system components on a video display moni-
`tor, so as to make the procedure easy and accurate.
`
`[0041] Still other advantages of the invention will become
`apparent
`to those skilled in the art upon a reading and
`understanding of the following detailed description, and
`accompanying drawings.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0042] The invention may take physical form in certain
`parts and arrangements of parts, a preferred embodiment and
`method of which will be described in detail in this specifi-
`cation and illustrated in the accompanying drawings which
`form a part hereof, and wherein:
`
`[0043] FIG. 1 shows images of typical prior art biopros-
`thetic valve having leaflets made of bovine pericardium
`mounted on a supporting stent;
`
`[0044] FIG. 2 shows a top plan view of the permanent
`frame, according to a preferred embodiment of the present
`invention;
`
`[0045] FIG. 3A shows a perspective view of the collaps-
`ible frame in accordance with a preferred embodiment of the
`present invention, in an expanded position;
`
`[0046] FIG. 3B shows a top plan view of the collapsible
`frame shown in FIG. 3A;
`
`[0047] FIG. 3C shows a top plan view of the collapsible
`frame shown in FIG. 3A, in a collapsed position.
`
`[0048] FIG. 4A illustrates a collapsible frame in an
`expanded position,
`in accordance with an alternative
`embodiment.
`
`[0049] FIG. 4B illustrates the collapsible frame of FIG.
`4A, in a collapsed position.
`
`[0050] FIG. 5 shows an enlarged partial sectional view of
`the collapsible and non-collapsible permanent frames,
`to
`illustrate the mating surfaces thereof;
`
`[0051] FIG. 6A shows an exemplary embodiment of a
`valve collapsing catheter;
`
`[0052] FIGS. 6B and 6C show an exemplary embodiment
`of a valve expanding catheter;
`
`[0053] FIG. 7A shows an exploded view of a catheter-
`based valve delivery system, including a surgical platform
`and numerous accessory devices and catheters, according to
`one preferred embodiment of the present invention;
`
`[0054] FIG. 7B shows an enlarged partial sectional view
`of a slotted catheter sheath, according to a preferred embodi-
`ment of the present invention;
`
`[0055] FIG. 7C shows an enlarged partial sectional view
`of an inner catheter, according to a preferred embodiment of
`the present invention;
`
`NORRED EXHIBIT 2111 - Page 28
`NORRED EXHIBIT 2111 — Page 28
`
`

`
`US 2001/0002445 A1
`
`May 31, 2001
`
`[0056] FIG. 7D is a schematic representation illustrating
`the operation of gripping means,
`in accordance with a
`preferred embodiment of the present invention;
`
`[0057] FIG. 7E illustrates a surgical platform having a
`check valve, in accordance with a preferred embodiment of
`the present invention;
`
`[0058] FIG. 8A shows an alternative embodiment of an
`expandable surgical platform;
`
`[0059] FIG. 8B is a schematic representation illustrating
`operation of the expandable surgical platform shown in FIG.
`8A;
`
`[0060] FIG. 9A illustrates a front view of the cardiac
`anatomic site;
`
`[0061] FIG. 9B illustrates a top view of the cardiac
`anatomic site shown in FIG. 9A;
`
`[0062] FIG. 9C is a simplified enlarged front view of the
`cardiac anatomic site shown in FIG. 9A.
`
`[0063] FIG. 10 shows a top plan view of a permanent base
`unit, according to an alternative embodiment of the present
`invention.
`
`[0064] FIG. 11 shows a perspective view of the permanent
`base unit, as shown in FIG. 10.
`
`[0065] FIG. 12 shows a perspective view of a collapsible
`frame (in an expanded position) of a collapsible valve,
`according to an alternative embodiment of the present
`invention.
`
`[0066] FIG. 13 shows a side view of the collapsible frame,
`as shown in FIG. 12.
`
`[0067] FIG. 14 shows a perspective view of the collaps-
`ible frame of FIGS. 13 and 14 (in a collapsed position),
`according to an alternative embodiment of the present
`invention.
`
`[0068] FIG. 15 shows a perspective view of the collaps-
`ible frame of FIGS. 12-14, in an expanded configuration, as
`an engaged with the permanent base unit shown in FIGS. 10
`and 11.
`
`[0069] FIG. 16 shows a perspective view of the collaps-
`ible cardiovascular valve in its expanded position (including
`the collapsible frame of FIGS. 12-14 and two valve leaflets,
`wherein the third valve leaflet is omitted for clarity).
`
`[0070] FIG. 17 shows a perspective view of the cardio-
`vascular valve system according to an alternative embodi-
`ment of the present invention, wherein the collapsible valve
`(including the collapsible frame of FIGS. 12-14 and two
`valve leaflets, wherein the third valve leaflet is omitted for
`clarity) is shown in an expanded position, as engaged with
`the permanent base unit shown in FIGS. 10 and 11.
`
`[0071] FIG. 18A shows a perspective view illustrating
`one method by which valve leaflets are connected with a
`collapsible frame.
`
`[0072] FIG. 18B shows a perspective view illustrating
`another method by which the valve leaflets are connected
`with a collapsible frame.
`
`[0074] FIG. 19A shows a partial perspective view illus-
`trating a method by which a collapsible frame of the
`collapsible valve is engaged with a permanent frame of the
`permanent base unit.
`
`[0075] FIG. 19B shows a partial perspective view illus-
`trating another method by which a collapsible frame of the
`collapsible valve is engaged with a permanent frame of the
`permanent base unit.
`
`[0076] FIG. 19C shows a partial perspective view illus-
`trating still another method by which a collapsible frame of
`a collapsible valve is engaged with a permanent frame of the
`permanent base unit.
`
`[0077] FIG. 20A shows a cross-sectional view taken
`along line A-A of FIG. 19A.
`
`[0078] FIG. 20B illustrates yet another alternative method
`by which a collapsible frame of a collapsible valve is
`engaged with a permanent frame of the permanent base unit.
`
`[0079] FIG. 21 shows a perspective view of a cardiovas-
`cular valve system comprised of a collapsible valve (includ-
`ing the collapsible frame of FIGS. 12-14 and two valve
`leaflets, wherein the third valve leaflet is omitted for clarity)
`and a permanent base unit, according to still another alter-
`native embodiment, wherein the collapsible frame is fitted
`over the permanent frame.
`
`[0080] FIG. 22 illustrates a cardiovascular valve system
`according to another alternative embodiment.
`
`[0081] FIGS. 23A-23C and 24 illustrate operation of a
`retaining clip of the cardiovascular valve system shown in
`FIG. 22.
`
`[0082] FIG. 24 illustrates the cardiovascular valve system
`according to the alternative embodiment of FIG. 22, show-
`ing the collapsible valve fitted over a catheter body and
`snares positioned over retaining clips.
`
`[0083] FIG. 25A shows a cross-sectional view of a col-
`lapsible valve fitted over a catheter body of a positioning
`catheter.
`
`[0084] FIG. 25B shows a cross-sectional view of a cath-
`eter body of a positioning catheter.
`
`[0085] FIG. 25C illustrates a contact area for the outer
`surface of a catheter body and a portion of a collapsible
`valve.
`
`[0086] FIGS. 26A and 26B illustrate a valve expanding
`catheter 160.
`
`[0087] FIGS. 26C and 26B illustrate a procedure for
`expanding a collapsible valve for installation thereof,
`in
`accordance with the alternative embodiment shown in FIG.
`22.
`
`[0088] FIGS. 27A-27C illustrate a cardiovascular valve
`system according to yet another alternative embodiment.
`
`[0089] FIGS. 28 and 29A-29C illustrate operation of an
`expanding lever for disengaging a collapsible valve from a
`base unit.
`
`[0073] FIG. 18C shows a perspective view illustrating
`still another method by which valve leaflets are connected
`with a collapsible frame.
`
`[0090] FIGS. 29D-29G illustrate the yet another alterna-
`tive embodiment of engaging a collapsible valve to a base
`unit.
`
`NORRED EXHIBIT 2111 - Page 29
`NORRED EXHIBIT 2111 — Page 29
`
`

`
`US 2001/0002445 A1
`
`May 31, 2001
`
`[0091] FIG. 30 illustrates use of a valve collapsing cath-
`eter in connection with the cardiovascular valve system of
`FIG. 27A.
`
`[0092] FIGS. 31A and 31B illustrate a surgical platform
`according to an alternative embodiment of the present
`invention, wherein a screen is incorporated to trap particu-
`lates (FIG. 31A), and a synthetic valve is incorporated to
`control the flow of blood (FIG. 31B).
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`
`[0093] The detailed description set forth below in connec-
`tion with the appended drawings is intended merely as a
`description of the presently preferred embodiments of the
`invention, and is not intended to represent or limit the form
`in which the present invention can be constructed or used.
`The description sets forth the function and sequence of steps
`for construction and implementation of the invention. It is to
`be understood that the same or equivalent functions and
`sequences may be accomplished by different embodiments
`that are also intended to be encompassed within the spirit
`and scope of the invention. For example, a similar valve
`system can be used to insert a similar collapsible valve (e.g.,
`a prosthetic valve or endoprosthesis) into the mitral position,
`the pulmonary and tricuspid positions of the heart or an other
`expandable prosthetic device into any other location within
`the vasculature or an organ of any patient. Moreover, while
`a preferred embodiment of the present invention is illus-
`trated herein as a cardiovascular valve system for use in
`connection with the heart, the present invention is contem-
`plated for use as a valve system with other parts of the
`cardiovascular system.
`
`In accordance with a preferred embodiment of the
`[0094]
`present invention, a system for inserting a valve into the
`aortic position using a catheter-based, endovascular, mini-
`mally invasive techniques is generally comprised of the
`following:
`
`(1) Avalve that can be collapsed for insertion,
`[0095]
`expanded when in place so as it fits securely within
`a permanent housing that remains in the patient, and
`collapsed again for removal once the tissue compo-
`nent of the collapsible valve wears out.
`
`(2) Amulti-component, catheter-based system
`[0096]
`for the percutaneous, removal and delivery of a
`collapsible valve.
`
`(3) A set of surgical tools that have fixtures
`[0097]
`similar to those at the ends of the catheters, for the
`surgical removal and delivery of a collapsible valve.
`
`(4) A device