3,548,417
`A
`R. e. KISCHER
`Dec. 22, 1970
`HEART VALVE HAVING A FLEXIBLE WALL WHICH ROTATES
`BETWEEN OPEN AND CLOSED POSITIONS
`Filed Sept‘. 5, ‘1967
`2 Sheets-Sheet 1
`
`'lillra. 4-.’
`
`INVENTOQ .
`
`RONA/1E G. K/so/ae
`ESQ/AZ 4-‘
`NORRED EXHIBIT 2201 - Page 1
`DTTOENEs/J‘.
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00111
`
`

`
`’
`
`3,548,417
`'
`R G. KISCHER
`,
`v Dec. 22, 1970
`HEART VALVE HAVING. A FLEXIBLE WALL WHICH ROTATES '
`BETWEEN OPEN AND CLOSED POSITIONS
`‘
`2 Sheets-Sheet 2
`
`'
`Filed Sept. 5, 1967
`
`Sig-‘FEW o g,3
`
`0 T TOENE 91:,
`
`NORRED EXHIBIT 2201 - Page 2
`
`

`
`United States Patent 0 "
`we
`
`3,548,417
`Patented Dec. 22, 1970
`
`1
`
`3,548,417
`HEART VALVE HAVING A FLEXIBLE WALL
`WHICH ROTATES BETWEEN OPEN AND
`CLOSED POSITIONS
`Ronnie G. Kischer, La Habra, Calif.; Jane N. Kischer,
`widow of said Ronnie G. Kischer, deceased
`Filed Sept. 5, 1967, Ser. No. 665,325
`Int. Cl. A6lf 1/22; A16k 15/14
`US. Cl. 3—1
`
`13 Claims
`
`5
`
`ABSTRACT OF THE DISCLOSURE
`A cardiac valve having a winding and unwinding move
`ment between open and closed positions and including thin
`sheet material extending about a central axis and having
`at one time a ?rst position in which the material is openly
`extended to de?ne a blood passage and at another time a
`second position in which the material is collapsed and
`pleated and partially rotated about the central axis to close
`the passage for blocking reverse flow of blood.
`
`15
`
`20
`
`25
`
`30
`
`40
`
`2
`In general, the invention may be succinctly described as
`a valve comprising a thin sheet material de?ning a through
`passage, ?ow through which is controllable by a winding
`pleated or accordion fold of the material.
`In particular, the invention provides a cardiac valve
`comprising thin sheet material impervious to blood and
`resistant to body ?uids and which extends about a central
`axis, thus to de?ne an open passage to pass blood; the
`material at another time has a second position in which
`it is collapsed to form pleats and is also at least partially
`rotated about the central axis. In the second position the
`material closes the passage and blocks reverse ?ow of
`blood therethrough.
`Collapse in the desired manner is facilitated by pro
`vision of stiifening support for the sheet material in con
`straining relation to induce the material to rotate in its
`movement between its ?rst and second position. Also,
`structure may be provided for implanting the valve in the
`heart, such as a base ring from which the sheet material
`may extend in the direction of natural blood flow.
`In certain preferred embodiments, the sheet material is
`frusto-conical when open and is provided with plural ribs
`which extend generally longitudinally of the material and
`in planes extending axially of the conical material. Such
`ribs may be formed integrally with the wall forming sheet
`material as thickened areas thereof and serve to de?ne cir
`cumferentially alternating relatively ?exible and relatively
`rigid wall portions, the former to follow and the latter
`to lead in the winding collapse of the valve material to
`produce overlapping, pleated ?aps.
`The relative size of the rigid wall portions is control
`lable by provision in the ribs of webs extending away’ from
`midribs, the webs having differential lengths as will be ex
`plained. Also, the wall may have plural cusps opposite
`its base which move helically on opening and closing
`movement of the valve and from which the midribs may
`proceed directionally toward the base. The latter may be
`reinforced against radial crushing by ventricular con
`tractions, such reinforcement being spaced from the rib
`lower termini to facilitate the winding movement of the
`sheet material above the base, relative to the base and
`about the valve longitudinal axis.
`BRIEF DESCRIPTION OF THE DRAWINGS
`In the drawings:
`FIG. 1 is a sectional view of a human heart showing
`the valve device of the present invention in open position
`in the place of the pulmonary valve;
`FIG. 2 is a view like FIG. 1 showing the present valve
`device in closed position in the place of the mitral valve;
`FIG. 3 is an enlarged perspective view of the arti?cial
`heart valve shown in FIG. 1;
`FIG. 4 is an enlarged view in section taken along line
`4-4 in FIG. 3;
`FIG. 5 is a plan view of the valve shown partially
`closed;
`FIG. 6 is a view in elevation of the partially closed
`valve shown in FIG. 5;
`FIG. 7 is a view like FIG. 5 showing the valve fully
`closed;
`FIG. 8 is a view like FIG. 6 showing the valve fully
`closed;
`FIG. 9 is a sectional view of the valve wall taken along
`line 9—9 in FIG. 6; and
`FIG. 10‘ is a view like FIG. 9 taken along line 10—10
`in FIG. 6.
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`With reference to the attached drawings in which one
`embodiment of the present invention is depicted, FIG. 1
`shows the present prosthetic valve device 10, in open
`NORRED EXHIBIT 2201 - Page 3
`
`BACKGROUND OF THE INVENTION
`Field of the invention
`This invention is concerned ‘with prosthetic devices and
`particularly with valves useful in replacement of natural
`heart valves. As is known the human heart includes four
`cavities. Communication therewith is controlled by valves
`speci?cally the aortic, tricuspid, mitral and pulmonary
`valves. These valves are remarkably similar in construction
`consisting of triangular cusps or lea?ets, the free ends of
`the mitral and tricuspid valves being supported by delicate
`tendons, the chordae tendinae, which insert into the papil
`lary muscles, thus to prevent wrong way opening of these
`antrioventricular valves. Defective natural valves, those
`which have been narrowed or surface roughened or which
`close incompletely, are desirably replaced. For successful
`replacement, the extremely critical opening and closing
`characteristics of the healthy natural valve must be ap
`proximated as closely as possible.
`Prior art
`Prior developments in the art may be classi?ed as either
`blood passing valves intended for use in mechanical
`“heart” pumps used in surgery or heart valves properly so
`called, i.e. those attached to and operative within the heart.
`It is with the latter group that the present invention is
`concerned. In US. Pat. 3,130,418 to Head, et al., a special
`ly woven and plastic impregnated valve device is disclosed.
`In US. Pat. 3,197,788 to Segger a valve device is de
`scribed which, like the Head, et al. invention, tried to
`simulate the action of the natural valve by a physical
`approximation of the natural valve cusps. US. Pat.
`3,263,239 to Edwards et al., utilizes the well known ball
`valve and cooperating seat combination to accomplish the
`check valve function of the natural valves.
`In the present invention an entirely different type of
`valve is produced. The design is predicated on a simulation
`of the function of the natural heart valve, without imita~
`tion of the structure of the natural valves, the simulation
`being found particularly in the aspect of positive and com
`plete closure following pumping discharge of blood there
`through without mechanical abuse of the‘ blood.
`SUMMARY OF THE INVENTION
`It is the major object of the present invention to provide
`a prosthetic heart valve suitable for the replacement of
`any of the natural heart valves. It is a further object to
`achieve opening and closing of the valve with a novel
`motion insuring reliable and positive opening and closure
`action for an inde?nitely long period.
`
`55
`
`65
`
`70
`
`

`
`30
`
`8,548,417
`4
`condition, substituted for the natural pulmonary valve,
`material and the orientation and strain factors likely to be
`between the right ventricle 12 and the pulmonary artery
`encountered in molding or otherwise shaping the valve.
`With reference to FIG. 4, the base 16 may typically be
`14 for controlling ?ow of blood from the heart, H, to the
`lungs and avoiding regurgitation or partial return ?ow
`ring like or toroidal, and the wall 18 may extend from
`from the artery to the right ventricle. The heart contrac
`the outer edge thereof. The base 16 may be formed as an
`annular ring apart from the wall 18 and fastened thereto
`tion pumps blood through the valve which can be seen
`or may, in preferred practice, be integrally molded with
`to include (FIG. 3) a base portion 16 and a wall portion
`or to the wall 18 in the valve manufacturing operation.
`18 having plural cusps 20 from which ribs 22 extend
`directionally toward the base circumferentially dividing
`Reinforcement of the base 16 against radial crushing may
`be desirable, particularly where the valve is integrally
`the wall into relatively ?exible sections 24 and relatively
`rigid sections 26. The valve is sutured at the base 16 to the
`molded and intended for use as an aortic valve. A pre
`artery wall 28 as by thread extending about or through
`formed ring of metal, plastic or a combination thereof
`may be used, or ?bers, preferably woven, e.g., Dacron
`the base, and typically about reinforcement 54 as seen
`cloth may be employed for reinforcement, and as an
`at 100 in FIG. 4.
`example an annular preformed Dacron cloth 54 is shown
`The versatility of the present valve device is illustrated
`embedded in the periphery of base 16 in FIG. 4.
`by its substitution in FIG. 2 for the mitral valve. This
`location is more critical than the pulmonary valve posi
`With reference now to FIGS. 5~8, the movement of
`tion and thus requires extreme precision and reliability in
`the valve of the present invention between open and
`closed positions will be described. Noted above was the
`operation when mounted as shown across the relatively
`requirement in a heart valve for fail-proof actuation of
`wide opening between the left atrium 30 and the left
`ventricle 32, illustrated in the closed position.
`the valve by pressure of the blood on either side thereof
`and with minimum mechanical abuse of the blood. It is
`With particular reference to FIG. 3 the cardiac valve 10
`a feature of the present valve device that opening and
`shown may be described as frusto-conical and composed
`of plural conical segments 34 which abut at spaced loca
`closing movement is effected over a very long surface
`relative to the diameter of the valve. This permits lower
`tions about the valve circumference to provide a wall
`ing of pressure per unit of area in closing the valve and
`18 extending about a central axis 38. "lhe segments 34
`minimizes risk of blood damage.
`are relatively wider at their bottoms adjacent the base 16
`than at their upper edge portions 40. The edge portion 40
`The present valve movement is a Winding movement,
`that is the valve 10-is at least partially rotated about its
`of each segment 34 terminates in an arcuate edge 42
`axis; the cusps 20 of the valve traveling helical paths.
`giving the valve a scalloped appearance with the circularly
`The slack or relatively ?exible portions 24 of the valve
`arranged peaks or cusps 20 at the abutment of adjacent
`wall 18 fold on themselves between the relatively rigid
`segments 34.
`'
`The wall 18 has relatively ?exible portion 24 formed
`wall portions 26 which thus converge on one another so
`centrally of segments 34 and relatively rigid portion indi
`that adjacent ?exible portions 24 double over and overlap
`cated at 26 and corresponding generally to the line of
`with one another to a greater or lesser extent as the
`abutment between adjacent segments. stiffening support
`valve wall 18 is ?attened.
`may be provided at the junctions between segments 34
`In FIGS. 5 and 6, the normal open position of the
`in the form of ribs 22 which as shown proceed direc
`valve 10 is shown. Cone segments 34 of the wall 18 are
`tionally from cusps 20 downward toward the base portion
`coaxial with the axial plane of the valve and de?ne a valve
`passage 56 into which ends 58 of ribs 22 project slightly.
`16, which base portion the ribs may or may not meet, de
`pending upon collapsing characteristics desired. The ribs
`The valve position shown in FIGS. 5 and 6 is the result
`22 may also project beyond the peaks 48 of the cusps 20
`of a pressure differential between the interior and exterior
`of the valve 10 in favor of the valve interior as is the case
`as shown in FIG. 3.
`The ribs 22 may be of any material compatible with
`for example for an aortic valve during a pumping con
`traction of the left ventricle. Upon cessation of the pump
`the use environment of the valve such as stainless steel or
`ing, the back pressure produced by the blood pumped
`high modulus plastic, secured by adequate means to the
`wall 18. Preferably, ribs 22 are formed integrally with
`through the valve tends to cause regurgitation or blood
`the molded plastic wall 18 by providing selectively in
`return, quickly reversing the pressure differential in favor
`creased thickness in the wall according to a predetermined
`of the valve exterior. At this point the valve 10 must
`close, or else already pumped blood must be repumped
`pattern to provide a localized increase in stiffness, which .
`will be generally proportionate to the thickness increase.
`imposing in all likelihood an intolerable burden on the
`heart.
`In order better to control areas of the adjacent segments
`34 beyond the immediate junction thereof, the ribs 22 are
`In the present valve closure is quick and sure. The shift
`provided with webs 50 which radiate preferably in den
`of incremental pressure to the exterior of valve 10 im
`droid array from the central portions or midribs 52 of the
`mediately causes an inward collapse of the valve wall 18.
`ribs. The webs 50 generally are base directed, i.e., proceed
`Because the wall is not uniformly collapsible owing to
`the circularly alternate ?exible and rigid portions 24 and
`toward the base 16 of the valve, regardless of the in-heart
`orientation of the valve device 10. The function of the
`26, the wall 18 tends to wind either right or left in col
`webs 50 is to provide stiffening ?ngers outward from the
`lapse, depending on the predisposition built into the wall
`midrib 52 to facilitate the desired mode of collapse of the
`by arrangement of the ribs 22 or other selective stiffen
`wall 18. Accordingly, the webs 50 will be relatively longer
`ing feature, relative to the base. The base 16 remains
`progressively as they increase in proximity to the base 16
`stationary and the wall 18 rotates with respect thereto
`along the midrib 52 due to the greater circumference of
`and at least partially about the axis 38 of the wall.
`the valve wall 18 proximate the base.
`With the reduction in the height of the wall 18 occa
`sioned by the collapse, the ?exible wall portions 24 move
`Ribs 22 are tapered to a minimum cross-section ad—
`from between the rigid portions 26 forming ?aps 60 pro
`jacent the cusps 20 and as such are sometimes termed
`jecting inwardly or outwardly and preferably outwardly
`banners. Webs 50 are similarly tapered, outward from
`midribs 52 to extinction on the wall 18. The wall itself
`as shown. Continued exertion of reverse ?ow pressure on
`is also preferably tapered frusto-conically upwardly from
`the flaps 60 forces the ?aps to lie ?at, upon one another
`the base 16, the taper of the wall 18 and a rib 22 being
`to an extent dependent on the concavity of the cone seg
`shown in the fragmentary views of FIGS. 9 and 10. The
`ments 34 which is a matter of design.
`maximum and minimum thicknesses of the wall 18 and
`On a further pumping contraction of the heart, the
`the ribs 22 and webs 50, as well as their taper, will be
`inner valve pressure will again exceed the outer and the
`selected with consideration for the speci?c heart valve to
`flaps 60 will reform the cone segments 34 as the ribs 22
`be produced, the relative stiffness of the fabricator-y
`move helically and apart to provide the valve opening 56.
`NORRED EXHIBIT 2201 - Page 4
`
`10
`
`60
`
`

`
`3,548,417
`6
`6. Cardiac valve according to claim 5 in which said
`base is rigid relative to said sheet material.
`7. Cardiac valve according to claim 5 including also
`midribs and plural webs extending from said ribs in
`dendroid arrangement.
`8. Cardiac valve according to claim 7 in which said
`ribs are formed integrally with said sheet material.
`9. Cardiac valve according to claim 5 in which said
`ribs are spaced from said base.
`10. Cardiac valve according to claim 1 in which said
`wall includes plural terminal cusps at the opposite end
`of the wall from the base.
`11. Cardiac valve according to claim 10 in which said
`relatively rigid portions comprise thickened areas form
`ing ribs in said wall and include raised midribs extending
`directionally from said cusps toward said base and raised
`webs extending away from said midribs and at opposite
`sides thereof, webs closer to said base being longer than
`webs closer to said cusps.
`12. Cardiac valve according to claim 11 in which said
`base and wall consists of integrally molded plastic
`material.‘
`13. Cardiac valve according to claim 12 in which said
`‘base includes reinforcement means to resist radial crush
`ing forces.
`14. Cardiac valve according to claim 14 in which said
`basev includes reinforcement structure to resist radial
`crushing forces.
`
`10
`
`20
`
`25
`
`It will be seen in FIGS. 7 and 8 that the rib ends meet
`at a common point 62 lying on the axis 38‘ and the ?aps
`60 resemble pleats or accordion folds.
`The present valve device can be formed of many ma
`terials known to the art including ole?n polymers and
`copolymers, polyamidcs, polyesters, silicones and the like
`solely or in combination with other materials of a plastic
`or metallic nature for speci?c properties, e.g., rigidifying
`the selected areas of the valve wall 18.
`The present design is advantageous in being readily
`formable in a single molding operation, with mold insert
`if desired, e.g., the preformed annular cloth 54.
`What is claimed is:
`1. Cardiac valve comprising a generally annular base
`carrying means for securing the valve in a heart blood
`passageway and a frusto-conical wall of ?exible sheet ma
`terial extending from the base and about a longitudinal
`axis, said wall having circularly alternating relatively
`rigid and relatively ?exible longitudinally extended por
`tions to rotate relative to the base about said axis in re
`sponse to relatively greater interior pressure in the valve
`to a ?rst position in which the wall is extended openly
`relative to said axis to de?ne an open passage to pass
`blood, and in response to relatively greater exterior pres
`sure on the valve to a second position in which the wall is
`collapsed by the relatively rigid wall portions converging
`on one another and the relatively ?exible wall portions
`therebetween folding on themselves to form pleats to
`close said passage for blocking reverse ?ow of blood
`therethrough.
`2. Cardiac valve according to claim 1 including also
`plural circularly spaced stiffening support means carried
`in local constraining relation with said sheet material to
`de?ne said rigid portions and to induce said rotation in
`response to movement of the wall material from said ?rst
`to said second positions.
`3. Cardiac valve according to claim 2 in which each
`of said stiifening support means extends along the sheet
`material in the plane of said axis when the wall is in said
`?rst position.
`4. Cardiac valve according to claim 1 including also
`cloth secured to said base to de?ne said means for secur
`ing said valve to the heart.
`5. Cardiac valve according to claim 2 in which said
`stilfening support means comprise ribs and in which said
`?exible portions between said ribs are cone segments.
`
`35
`
`40
`
`45
`
`References Cited
`UNITED STATES PATENTS
`2,662,724 12/ 1953 Kravagna _______ __ 137—5'25.1
`2,682,057
`6/1954 Lord ________________ __ 3—1
`3,047,013
`7/1962 Baumbach ______ __ l37-—525.l
`3,118,468
`1/1964 Bochan _________ __ 137—525.1
`3,197,788
`8/1965 Segger _______________ __ 3——1
`3,279,996 10/1966 Long et a1 __________ __ 3—1HV
`3,416,562 12/1968 Freeman ____________ __ 3—1X
`FOREIGN PATENTS
`8/1955 Canada ___________ __ 137—525
`
`515,372
`
`RICHARD A. GAUDET, Primary Examiner
`R. L. FRINKS, Assistant Examiner
`U.S. Cl. X.-R.
`
`137-525 .1
`
`NORRED EXHIBIT 2201 - Page 5
`
`

`
`UNITED STATES PATENT OFFICE
`CERTIFICATE OF CORRECTION
`3, 548 ,417
`Dated
`December 22 , 1970
`
`Ronnie G. Kischer
`
`Patent No,
`
`Inventor(s)
`
`It is certified that error appears in the above-identified patent
`and that said Letters Patent are hereby corrected as shown below:
`
`Column 6, lines 26 to 28, cancel "14. Cardiac valve
`according to claim 14 in which said base includes reinforcemer
`structure to resist radial crushing £orces.".
`
`Signed and sealed this 1st day of June .1971.
`
`(SEAL)
`Attest:
`
`EDWARD M.FLETCHER,JR.
`Attesting Officer
`
`WILLIAM E. SCHUYLER, JR.
`Commissioner of Patents
`
`1 FORM PO-105O (10-69)
`
`............................. r- I “n 41-‘
`
`USCOMM-DC 50374
`
`NORRED EXHIBIT 2201 - Page 6