United States Patent (19)
`Bessler et al.
`
`54
`
`(75)
`
`73)
`
`ARTIFICIAL, HEART WALVE AND METHOD
`AND DEVICE FOR IMPLANTING THE
`SAME
`
`Inventors: Marc Bessler, Teaneck, N.J.; Timothy
`A. M. Chuter, Malmö, Sweden
`Assignee: The Trustees of Columbia University
`in the City of New York, New York,
`N.Y.
`
`Appl. No.: 668,376
`Filed:
`Jun. 21, 1996
`Int. Cl. ...................................................... A61F 2/24
`U.S. Cl. ................................................. 623/2; 623/900
`Field of Search ..................................... 623/2, 1,900
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,574,865 4/1971 Hamaker ..................................... 623/2
`3,671,979 6/1972 Moulopoulos.
`3,874,388 4/1975 King et al..
`4,056,854 11/1977 Boretos et al..
`4,592,340 6/1986 Boyles.
`4,631,052 12/1986 Kensey.
`4,692,139 9/1987 Stiles.
`4,705,507 11/1987 Boyles.
`4,794,928
`1/1989 Kletschka.
`4,816,029 3/1989 Penny, III et al. ........................ 623/2
`4,883,458 11/1989 Shiber.
`4,886,061 12/1989 Fischell et al..
`4,960,424 10/1990 Grooters.
`4,966,604 10/1990 Reiss.
`4,979,939 12/1990 Shiber.
`4,994,077
`2/1991 Dobben .
`5,007,896
`4/1991 Shiber.
`5,019,090 5/1991 Pinchuk.
`5,032,128
`7/1991 Alonso.
`5,047,041
`9/1991 Samuels.
`5,069,679 12/1991 Taheri.
`5,080,660
`1/1992 Buelna.
`5,133,725
`7/1992 Quadri.
`
`A
`
`
`
`USOO5855601A
`Patent Number:
`11
`(45) Date of Patent:
`
`5,855,601
`Jan. 5, 1999
`
`8/1992 Bowald.
`5,141,491
`5,152,771 10/1992 Sabbaghian et al..
`5,163,953 11/1992 Vince.
`5,297,564 3/1994 Love .
`5,332,402 7/1994 Teitelbaum.
`5,370,685 12/1994 Stevens.
`5,397,351 3/1995 Pavcnik et al. ............................. 623/2
`5,411,552 5/1995 Andersen et al. .......................... 623/2
`5,469,868 11/1995 Reger.
`5,480,424
`1/1996 Cox.
`5,489,295
`2/1996 Piplani et al. .............................. 623/1
`5,489,298 2/1996 Love et al..
`5,562,729 10/1996 Purdy et al. ................................ 623/2
`5,571,175 11/1996 Vanney et al. .............................. 623/2
`
`FOREIGN PATENT DOCUMENTS
`
`1644946A 4/1991 Russian Federation.
`1697790 12?1991 U.S.S.R. .................................... 623/2
`WO 91/17118 11/1991 WIPO.
`WO 91/17720 11/1991 WIPO.
`94.07437 4/1994 WIPO ........................................ 623/2
`
`Primary Examiner Michael J. Milano
`Assistant Examiner Tram A. Nguyen
`Attorney, Agent, or Firm-Cowan, Liebowitz & Latman,
`P.C.; William H. Dippert
`57
`ABSTRACT
`An artificial heart Valve comprises a relatively rigid Stent
`member having a first cylindrical shape and a flexible valve
`disposed in the Stent member, the Stent member being
`Self-expandable to a second cylindrical shape and collaps
`ible to its first cylindrical shape. The valve comprises a
`circular portion comprising a plurality of leaflets extending
`from the periphery of the circular portion towards the center
`thereof, the leaflets being configured to allow for flow of
`blood through the valve in one direction only. The diameter
`of the circular portion is Substantially the same as the inside
`diameter of the stent member when the stent member is in
`its Second cylindrical shape, the valve member being
`attached to the Stent member.
`
`20 Claims, 8 Drawing Sheets
`
`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 1 of 15
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`

`

`U.S. Patent
`
`Jan. 5, 1999
`
`Sheet 1 of 8
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`5,855,601
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`
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`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 2 of 15
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`

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`U.S. Patent
`
`Jan. 5, 1999
`
`Sheet 2 of 8
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`5,855,601
`
`A/64
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`
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`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 3 of 15
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`

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`U.S. Patent
`
`Jan. 5, 1999
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`Sheet 3 of 8
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`5,855,601
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`A/G6
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`54
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`52
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`53
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`54
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`50
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`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 4 of 15
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`U.S. Patent
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`Jan. 5, 1999
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`Sheet 4 of 8
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`5,855,601
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`08
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`WL
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`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 5 of 15
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`U.S. Patent
`
`Jan. 5, 1999
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`Sheet 5 of 8
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`5,855,601
`
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 6 of 15
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`U.S. Patent
`
`Jan. 5, 1999
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`Sheet 6 of 8
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`5,855,601
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`
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`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 7 of 15
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`

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`U.S. Patent
`
`Jan. 5, 1999
`
`Sheet 7 of 8
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`5,855,601
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`03
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`O
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`04
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`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 8 of 15
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`U.S. Patent
`
`Jan. 5, 1999
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`Sheet 8 of 8
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`5,855,601
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`A/6/6
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`20
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`22
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`26
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`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 9 of 15
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`

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`1
`ARTIFICIAL, HEART WALVE AND METHOD
`AND DEVICE FOR IMPLANTING THE
`SAME
`
`FIELD OF THE INVENTION
`The present invention relates to novel artificial heart
`Valves. More particularly, the present invention relates to
`novel heart Valves that are especially adapted for placement
`using minimally invasive Surgical techniques and to the
`method and device useful for Such placement.
`
`5
`
`BACKGROUND OF THE INVENTION
`Over the past Several years a number of less invasive or
`minimally invasive Surgical techniques have been devel
`oped. Examples of Such techniques are various endoscopic
`or laparoscopic procedures, angioplasty procedures, atherec
`tomy procedures, and the like. While the instruments and
`devices used in these minimally invasive procedures are
`complex and hence relatively expensive, the procedures are
`gaining more and more acceptance. It is believed the reasons
`for this acceptance are the reduced risk to the patient, as the
`patient often doesn’t have to undergo general anesthesia or
`the time under general anesthesia is greatly reduced.
`Perhaps, more importantly, the recovery time required after
`a minimally invasive procedure is much less, thus greatly
`reducing hospital costs.
`One of the more invasive procedures being performed
`today is open heart Surgery. Such procedures require the use
`of general anesthesia, Sternotomy, use of extracoporeal
`by-pass, recovery in an intensive care unit, and a stay of at
`least a few days in the hospital. Although Such procedures
`carry a low mortality rate, they are quite expensive.
`Currently in the United States approximately 100,000
`defective heart Valves are replaced annually, at an approxi
`mate cost of S30-50,000 per procedure, and thus it would be
`desirable if heart Valves could be replaced using minimally
`invasive techniques. It would be especially advantageous if
`a defective heart valve could be removed via an endovas
`cular procedure, that is, a procedure where the invasion into
`the body is through a blood vessel Such as the femoral artery.
`The procedure is then carried out percutaneously and trans
`luminally using the vascular System to convey appropriate
`devices to the position in the body wherein it is desired to
`carry out the desired procedure. An example of Such a
`procedure would be angioplasty, wherein a catheter carrying
`a Small balloon at its distal end is manipulated through the
`body's vessels to a point where there is a blockage in a
`vessel. The balloon is expanded to create an opening in the
`blockage, and then the balloon is deflated and the catheter
`and balloon are removed from the vessel.
`Endovascular procedures have substantial benefits both
`from the Standpoint of health and Safety as well as cost. Such
`procedures require minimal invasion of the human body, and
`there is consequently considerable reduction and in Some
`instances even elimination, of the use of a general anesthesia
`and much shorter hospital stayS.
`In the last few years a number of atherectomy devices
`have been developed. These are endovascular devices used
`to remove plaque and other abnormal deposits from vessels.
`Representative examples of Such devices are those disclosed
`in U.S. Pat. Nos. 4445,509, 4,646,736, and 4,990,134.
`A number of minimally invasive techniques for replacing
`heart Valves have been developed. Such techniques have
`been reported in an article by H. R. Andersen et al., entitled
`“Transluminal Implantation of Artificial Heart Valves”,
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`5,855,601
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`2
`European Heart Journal (1992), Vol. 13, pp. 704–708; in an
`article by L. L. Knudsen et al., entitled “Catheter-Implanted
`Prosthetic Heart Valves”, The International Journal of Arti
`ficial Organs, Vol. 16, No. 5 (1993), pp. 253–262; and in an
`article by D. Pavcnik et al., entitled “Development and
`Initial Experimental Evaluation of a Prosthetic Aortic Valve
`for Trans-Catheter Placement”, Radiology (1992), Vol. 183,
`pp. 151-154. While the devices and techniques reported are
`clearly experimental, it appears that each of them Suffers
`from one or more of the following problems: (1) Secure
`placement of the heart valve; (2) durability of the heart
`valve; (3) ease of placement; (4) thrombogenicity, (5) leak
`age or regurgitation of blood, (6) excessive pressure gradient
`across the valve, and (7) size of the device and delivery
`System, as well as other similar problems. In addition, none
`of the above described devices or methods deals with the
`presence of a diseased or defective native valve.
`An endovascular valve replacement procedure is
`described in Stevens, U.S. Pat. No. 5,370,685. While it
`cannot be discerned whether the procedure disclosed will
`work, it is evident that the replacement valve is structurally
`limited and will have the disadvantages associated with the
`problems discussed above.
`OBJECTS OF THE INVENTION
`It is an object of the present invention to provide endo
`vascular procedures and devices for the percutaneous and
`transluminal replacement of diseased or defective heart
`valves.
`It is also an object of the present invention to provide a
`heart Valve that can be relatively easily placed and Secured
`in position.
`It is a further object of the present invention to provide a
`Valve that is relatively non-thrombogenic and eliminates
`undesirable leakage.
`It is a still further object of the present invention to
`provide a method and device for the Simple placement and
`Securement of the new and improved heart Valve in the
`desired position in a patient.
`It is likewise an object of the present invention to provide
`a method and device for implanting an artificial heart Valve
`using minimally invasive techniques especially endovascu
`lar techniques.
`It is an even further object of the present invention to
`provide a method and device for the percutaneous and
`transluminal removal of a defective heart valve.
`It is additionally a further object of the present invention
`to provide for the minimally invasive or endovascular place
`ment of heart Valves while preventing embolization.
`These and other objects of the invention will become
`more apparent in the discussion below.
`SUMMARY OF THE INVENTION
`The invention herein encompasses methods and devices
`for the endovascular removal and replacement of diseased or
`defective heart valves. The invention includes a new heart
`Valve which may be implanted percutaneously and
`transluminally, which heart Valve comprises a Stent member
`and a valve means. The Stent member is Self-expanding and
`has within it valve means that permit flow in only one
`direction. Preferably the stent member has barbs which
`anchor the expanded Stent member at a desired site. A
`cutting mechanism is used to remove the diseased or defec
`tive heart Valve, and then the replacement valve is inserted
`percutaneously to the Site, where it is released in a controlled
`fashion from the distal end of a catheter.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 10 of 15
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`5,855,601
`
`3
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a front, partially cross-sectional view of an
`artificial heart Valve of the present invention;
`FIG. 2 is a top view of the artificial heart valve depicted
`in FIG. 1;
`FIG. 3 is a bottom view of the artificial heart valve
`depicted in FIG. 1;
`FIG. 4 is a perspective, partially cross-sectional view of
`an artificial heart Valve of the invention in an expanded
`configuration;
`FIG. 5 is a perspective view of an artificial heart valve of
`the invention in a collapsed or constrained configuration;
`FIG. 6 is an expanded front view of a Segment of one type
`of stent member that may be used in the artificial heart
`valves of the invention;
`FIG. 7 is a front, partially cross-sectional view of another
`embodiment of an artificial heart valve of the invention;
`FIG. 8 is a partially cross-sectional view of a device
`according to the invention for removing a defective or
`diseased heart Valve;
`FIG. 9 is an enlarged, cross-sectional view of the distal
`end of the device shown in FIG. 8:
`FIG. 10 is a view taken along line 10-10 of FIG. 9;
`FIG. 11 is a view taken along line 11-11 of FIG. 9;
`FIG. 12 is a cross-sectional view of a device of the
`invention for the percutaneous and transluminal implanta
`tion of a heart valve;
`FIG. 13 is an enlarged, cross-sectional view taken along
`line 13–13 of FIG. 12;
`FIG. 14 is an enlarged, cross-sectional view of the distal
`end of the device depicted in FIG. 12 showing the heart
`Valve of the invention in a partially ejected State;
`FIG. 15 is an enlarged, cross-sectional view of the distal
`end of the device depicted in FIG. 12 showing the heart
`valve fully ejected from the device; and
`FIG. 16 is a partially cross-sectional view of an artificial
`heart Valve according to the invention useful for venous
`insufficiency.
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`opposite direction. Preferably the arcuate portion of the
`Valve means contains a plurality of leaflets and most pref
`erably three leaflets.
`The cuff portion of the valve means is attached to the stent
`member and may extend partly or wholly around the outer
`perimeter of the stent member. In some of the preferred
`embodiments of the artificial heart valve of the invention,
`the cuff portion of the valve means extends on only one side
`of the circular portion of the stent member. The flexible
`Valve means preferably comprises porcine pericardium con
`figured with three leaflets.
`Preferably the stent member carries a plurality of barbs
`extending outwardly from the outside Surface of the Stent
`member for fixing the heart valve in a desired position. More
`preferably the barbs are disposed in two spaced-apart, cir
`cular configurations with the barbs in one circle extending in
`an upstream direction and the barbs in the other circle
`extending in a downstream direction. It is especially pref
`erable that the barbs on the inflow side of the valve point in
`the direction of flow and the barbs on the outflow side point
`in the direction opposite to flow. It is preferred that the stent
`be formed of titanium alloy wire or other flexible, relatively
`rigid, physiologically acceptable material arranged in a
`closed Zig-Zag configuration. Such a configured Stent mem
`ber will readily collapse and expand as preSSure is applied
`and released, respectively.
`The invention includes methods and devices for the
`percutaneous and transluminal removal of the diseased or
`defective heart Valve and the percutaneous and transluminal
`implantation of the new heart valve described above. The
`defective heart valve is removed by a suitable modality, such
`as, for example, laser, ultrasound, mechanical, or other
`Suitable forms of delivery of energy, or phacoemulsion,
`including, but not limited to, laser lithotripsy, mechanical
`lithotripsy, electrohydraulic lithotripsy, and laser or
`mechanical ablation. For example, the valve can be ground
`or cut into fine particles or pieces and the particles are
`gathered and removed. The device for grinding or cutting the
`defective heart Valve and removing the debris can include a
`rotating cutting tool mounted on the end of a flexible drive
`shaft. The drive shaft is surrounded over most of its length
`by a guiding catheter. The cutting tool, which is inserted into
`a vessel of the patient and guided to the location of the
`defective heart Valve, may comprise cutting blades disposed
`at its distal end. The blades are configured Such that the
`debris that is created by the cutting action is thrown or
`ejected proximal of the distal end. Disposed close to the
`cutting blades and proximal thereof is a collecting member
`which preferably has a concave shape and is expandable to
`occlude the aorta as well as to catch debris. If desired the
`collecting member may be perforated So that Suction may be
`used to aid in the removal of the ground debris.
`The system for implanting the above described artificial
`heart Valve percutaneously and transluminally includes a
`flexible catheter which may be inserted into a vessel of the
`patient and moved within that vessel. The distal end of the
`catheter, which is hollow and carries the artificial heart valve
`of the present invention in its collapsed configuration, is
`guided to a Site where it is desired to implant the artificial
`heart Valve. The catheter has a pusher member disposed
`within the catheter lumen and extending from the proximal
`end of the catheter to the hollow section at the distal end of
`the catheter. Once the distal end of the catheter is positioned
`as desired, the pusher mechanism is activated and the distal
`portion of the artificial heart valve is pushed out of the
`catheter and the Stent member partially expands. In this
`position the Stent member is restrained So that it doesn’t pop
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`The present invention includes methods and devices for
`implanting a heart Valve percutaneously and transluminally.
`The artificial heart valves of the invention, which are
`capable of exhibiting a variable diameter between a com
`pressed or collapsed position and an expanded position,
`50
`comprise (1) a relatively rigid stent member and (2) a
`flexible valve means. The Stent member is Self-expanding
`and has a first cylindrical shape in its compressed or col
`lapsed configuration and a Second, larger cylindrical shape
`in its expanded configuration. The flexible valve means
`comprises a generally arcuate center portion and, preferably,
`a peripheral upstanding cuff portion. The flexible valve
`means is disposed within the cylindrical Stent member with
`the arcuate portion transverse of and at Some acute angle
`relative to the stent walls. The diameter of the arcuate
`portion is Substantially the Same as the inside diameter of the
`Stent member in its initial expanded configuration. The
`peripheral upstanding cuff portion is disposed Substantially
`parallel to the walls of the stent member.
`The arcuate portion of the valve means contains at least
`one slit to form leaflets which open in response to blood flow
`in one direction and close in response to blood flow in the
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`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 11 of 15
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`S
`out and is held for controlled release, with the potential that
`the artificial heart valve can be recovered if there is a
`problem with the positioning or the like. The catheter is them
`retracted Slightly and the artificial heart Valve is completely
`pushed out of the catheter and released from the catheter to
`allow the stent member to fully expand. If the stent member
`includes two circles of barbs on its outer Surface as previ
`ously described, the first push and retraction will Set one
`circle of barbs in adjacent tissue and the Second push and
`release of the artificial heart valve will set the other circle of
`barbs in adjacent tissue and Securely fix the artificial heart
`Valve in place when the valve is released from the catheter.
`Alternatively, or in combination with the above, the heart
`Valve could be positioned over a guidewire.
`The invention can perhaps be better appreciated by ref
`erence to the drawings. An artificial heart Valve according to
`the present invention is set forth in FIGS. 1 to 3. The
`artificial heart valve 20 is comprised of a stent member 21
`and a flexible valve means 22. In this embodiment the stent
`member 21 is comprised of Stainless Steel wire in a Sine
`wave-like configuration as shown in FIG. 1. The center
`portion 23 of Valve member 22 is generally arcuate in shape
`and comprises three leaflets 24 as shown, although it is
`understood that there could be from 2 to 4 leaflets. A cuff
`portion 25 extends from the periphery of the circular portion
`27 along the outside of the stent member 21 and is attached
`to the stent member 21 by a plurality of Sutures 26.
`FIG. 4 is a perspective view of another embodiment of an
`artificial heart valve 30 of the invention. The heart valve 30
`has a generally circular shape with the walls 31 of the
`cylinder being formed by the stent member 32. The stent
`member 32 is a wire formed in a closed Zig-Zag configura
`tion. The member has an endless Series of Straight Sections
`33 joined by bends 34. The valve member 35 is flexible and
`includes a plurality of leaflets 36.
`The leaflet portion of the valve member 35 extends across
`or transverse of the cylindrical stent. The leaflets 36 are the
`actual valve and allow for one-way flow of blood. Extending
`from the periphery of the leaflet portion is a cuff portion 37.
`The cuff portion 37 extends adjacent the stent walls 31 in the
`direction of the arrow A. The cuff portion is attached to the
`stent by Sutures 38.
`The configuration of the stent member 32 and the flexible,
`resilient material of construction allows the valve to collapse
`into a relatively small cylinder 40 as seen in FIG. 5. The
`artificial heart Valve will not stay in its collapsed configu
`ration without being restrained. Once the restraint is
`removed, the Self-expanding Stent member 32 will cause the
`artificial heart Valve to take its expanded configuration, as
`seen in FIG. 4.
`An enlarged view of a preferred embodiment of a Stent
`member for use in the artificial heart valve of the invention
`is depicted in FIG. 6. The stent member 50 includes a length
`of wire 51 formed in a closed Zig-Zag configuration. The
`wire can be a single piece, Stamped or extruded, or it could
`be formed by welding the free ends together as at 52. The
`straight sections 53 of the stent are joined by bends 54. The
`Stent is readily compressible to a Small cylindrical shape and
`resiliently self-expandable to the shape shown in FIG. 6.
`Another embodiment of the artificial heart valve of the
`present invention is depicted in FIG. 7. In this embodiment
`the heart valve 60 has a modified sine wave configuration.
`AS Seen in the drawing every other wave 61 has approxi
`mately 0.50-0.75 the amplitude of adjacent waves 62. The
`flexible valve member 63 is disposed at the crown or top of
`the Smaller waves. The larger waves carry a plurality of
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`barbs 64 for holding the valve in place once it has been
`appropriately positioned.
`The stent members of the artificial heart valves of the
`present invention may be made from Elgiloy alloy, titanium,
`titanium alloy, nitinol, Stainless Steel, or other resilient,
`flexible non-toxic, non-thrombogenic, physiologically
`acceptable and biocompatible materials. The configuration
`may be the Zig-Zag configuration shown or a Sine wave
`configuration, mesh configuration or a similar configuration
`which will allow the stent to be readily collapsible and
`Self-expandable. When a Zig-Zag or Sine wave configured
`stent member is used, the diameter of the wire from which
`the stent is made should be from about 0.010 to 0.035 inches,
`preferably from about 0.012 to 0.025 inches. The diameter
`of the stent member will be from about 1.5 to 3.5 cm,
`preferably from about 1.75 to 3.00 cm, and the length of the
`stent member will be from about 1.0 to 10 cm, preferably
`from about 1.1 to 5 cm.
`The valve member is flexible, compressible, host
`compatible, and non-thrombogenic. The valve can be, for
`example, a glutaraldehyde fixed porcine aortic valve which
`has three cusps that open distally to permit unidirectional
`blood flow. The valve can also be fresh, cryopreserved or
`glutaraldehyde fixed allografts or Xenografts. The optimal
`material will be synthetic such that it is manufactured from
`non-biological materials, non-thrombogenic, flexible Such
`that it can be transported through the vasculature, biocom
`patible and very durable Such that it can withstand a per
`manent fixation at the valve site. Biocompatible materials
`Such as polytetrafluoroethylene, polyester and the like may
`be used.
`In FIGS. 8 through 11 there is shown a device for the
`percutaneous and transluminal removal of a diseased or
`defective heart valve. The device 70 includes a cutting tool
`71 disposed at the distal end of the device 70. As shown in
`FIG. 10 cutting tool 71 has a plurality of abrasive surfaces
`72 on its outer Surface for cutting or grinding away the
`defective heart valve. Abrasive surfaces 72 comprise dia
`mond chips, Small metal blades, or other similar abrading
`means that would be effective to safely remove the defective
`heart valve. The cutting tool 71 is rotated by a flexible
`transluminal drive shaft 73, which is preferably contained
`along substantially its entire length in a flexible catheter 74
`made of physiologically acceptable plastic material. At the
`proximal end of the catheter 74 remote from the cutting tool
`71 there is a catheter connector 75 to connect the catheter 74
`to a drive shaft bearing block 76. The bearing block includes
`a central cavity 77 and a port 78. The proximal end of the
`drive shaft 73 is connected to and through a prime mover or
`motor 79 for rotation of drive shaft 73 and cutting tool 71.
`As is more clearly shown in FIG. 9, disposed just proxi
`mal of the cutting tool 71 is a collecting member 80 for
`collecting debris generated by the cutting or grinding away
`of the defective heart valve. The collecting member is
`circular, preferably with a concave shape for directing debris
`toward the annular space 81 between drive shaft 73 and
`catheter 74. Suction may be applied to the port 78 in bearing
`block 76 to assist in removal of debris from the operative
`site. Collecting member 80 preferably expands due to an
`inflatable component to cause the outward radial portion of
`collecting member 80 to abut the inner surface of the
`appropriate vessel. Thus, all or part of collecting member 80
`could be inflatable either in a single inflatable member or a
`series of inflatable members. Catheter 74 would contain one
`or more inflation lumens, not shown, in fluid communication
`with the one or more parts of collecting member 80 to be
`inflated.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1006, p. 12 of 15
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`

`7
`It is preferred that the cutting tool 71 have an initial,
`relatively Small diameter configuration and then a larger
`configuration as drive shaft 73 and cutting tool 71 are
`rotated. Alternatively, cutting tool 71 could be mechanically
`connected to a mechanical rod extending to the proximal end
`of catheter 74 to cause cutting tool 71 to expand prior to
`contact with the defective heart valve.
`Suction may be applied to the port 78 in the bearing block
`76 to assist in the removal of debris from the operative site.
`Distal protective balloon 82 which is inflated through a
`lumen in catheter 86 within drive shaft 73, is inflated to a
`diameter slightly larger than the extended diameter of cut
`ting tool 71.
`It is preferred that both the cutting tool 71 and the
`collecting member 80 be expandable. In the embodiment
`shown the cutting tool 71 comprises a plurality of leaves 83
`and the collecting member basin 80 also comprises a plu
`rality of leaves 84. In both instances the leaves may be
`mechanically contracted So as to overlap adjacent leaves and
`reduce the diameter of the respective unit. This will allow
`both units to be collapsed while being inserted in the vessel
`and guided to the operative site. The cutting 71 tool is then
`rotated at a relatively high speed of 3000 to 4000 rpm to
`grind away the defective valve. The resultant debris is
`collected in the collecting member 80 and removed from the
`site with the aid of Suction.
`The device set forth in FIGS. 12 and 13 represents a novel
`device for implanting the artificial heart Valves of the present
`invention. The device 90 comprises a flexible catheter 91 for
`percutaneous and transluminal delivery of the heart Valve to
`the desired site. A heart valve 92 of the invention is carried,
`in its collapsed state, at the distal end of the catheter 91
`where the catheter walls maintain the valve 92 in its col
`lapsed state. Disposed within the catheter 91 is a hollow
`flexible pusher member 93, which is movable longitudinally
`with respect to the catheter 91. A guidewire 94 having a
`blunt end 95 is disposed through a lumen 97 of the pusher
`member 93 and is used to guide the distal end of the catheter
`91 to the desired site. Means 96 is also disposed through
`lumen 97 of the pusher member 93 for holding the valve 92
`in place and allowing release of the valve 92 when desired,
`as will be more fully described in conjunction with FIGS. 14
`and 15.
`In FIG. 14 there is shown an implanting device 100 of the
`present invention with a heart valve 101 partially ejected,
`and FIG. 15 shows the device 100 with the heart valve 101
`fully ejected. In FIG. 14 the catheter 102 has been brought
`to the appropriate site and the guide wire removed proxi
`mally. The pusher member 103 has been moved forward
`longitudinally of the catheter 102 to eject approximately
`one-half of the heart valve 101 from the distal end of the
`catheter 102. As seen in the drawing the distal end of the
`valve 101 is expanded and a slight pull of the entire unit will
`set the first circle of barbs 104 in the vessel wall. The heart
`valve 101 is held in place within the delivery catheter by a
`pair of threads or sutures 105. The sutures are looped
`through an opening 106 in the pusher member 103 and then
`passed about a portion of the heart valve 101 as shown. The
`other end of the suture 105 contains a loop 107. A tension
`thread 108 is passed through the suture loops and down
`through the center of the pusher member 103 to the proximal
`end of the catheter 102. As seen in FIG. 15 the heart valve
`101 has been completely ejected from the catheter 102. The
`tension thread 108 has been removed and the pusher mem
`ber 103 longitudinally retracted. The looped sutures have
`been disengaged from the heart valve 101 and the second
`circle of barbs 109 set in the vessel wall and the valve
`implanted.
`
`35
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`40
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`45
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`50
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`55
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`60
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`65
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`5,855,601
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`15
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`25
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`8
`Before the invention herein is used, the patient is Studied
`to determine the architecture of the patient's heart. Useful
`techniques include fluoroscopy, transe Sophageal
`echocardiography, MRI, and angiography. The results of this
`Study will enable the physician to determine the appropriate
`sized cutting tool and heart Valve to employ.
`To use Applicants invention, a guidewire is inserted
`percutaneously and transluminally using Standard Vascular
`or angiography techniques. The distal end of the guidewire
`is manipulated to extend through and across the defective
`heart Valve. Then a catheter corresponding to catheter 74 is
`advanced distally through the femoral artery to a point
`proximal to the defective heart Valve, between the origin of
`the coronary artery and the origin of the right Subclavian
`artery. The position of the distal end of catheter 74 can be
`monitored by observation of radiopaque markers. Collector
`member 80 is preferably inflated and occludes the aorta at a
`point between the origin of the coronary artery and the right
`subclavian artery. Next, balloon 87 and cutting tool 71 are
`advanced through catheter 74 so that the cutting tool 71 and
`uninflated balloon 87 are distal to the defective heart valve.
`Optionally an additional Step, Such as balloon dilatation or
`atherectomy, may be required to provide a passageway
`through the heart valve.
`A catheter is placed into the coronary Sinus via a trans
`jugular puncture. This catheter is used for infusion of blood
`or cardioplegia Solution during the portion of the procedure
`when the aorta is occluded. The absence of valves in the
`cardiac venous System allows retrograde flow So that there
`will be an effluence of fluid from the coronary arteries. This
`flow of fluid is desired to prevent embolization of material
`into the coronary arteries during the procedure.
`Once the cutting tool 71 is in place, the balloon 82 is
`inflated and flexible shaft 73 is rotated. Once cutting tool 71
`has reached the appropriate rotation Speed, cutting tool 71 is
`pulled proximally to remove the defective heart valve.
`Balloon 87 and cutting tool 71 are spaced apart so that
`inflated balloon 87 will be stopped by the perimeter, unre
`mo