United States Patent
`Ersek
`
`3,657,744
`[151
`[451 Apr. 25, 1972
`
`[54]
`
`[72]
`[731
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`[22]
`[21]
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`[521
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`[51]
`[58]
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`[56]
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`METHOD FOR FIXING PROSTHETIC
`IMPLANTS IN A LIVING BODY
`Inventor:
`Robert A. Ersek, St. Louis Park, Minn.
`Assignee:
`The Regents of the University of Min
`nesota, Minneapolis, Minn.
`May 8, 1970
`Filed:
`Appl. No.: 35,815
`
`U.S. Cl .................................... ..3/l, 3/DIG. l, 3/D1G. 3,
`>
`128/334 R
`Int. Cl. ....................................... ..A6lf l/22, A6lf l/24
`Field ofSearch ................. “l28/334 R, 334 C, 341, 343,
`128/348; 3/1, DIG. l, DIG. 3
`
`'
`
`References Cited _
`
`UNITED STATES PATENTS
`
`3,509,883
`5/1970
`3,221,746 12/1965
`
`...... ..l28/348
`Dibelius....
`Noble ............................... ..l28/334 R
`
`FOREIGN PATENTS OR APPLICATIONS _
`
`180,750 9/1966
`
`U.S.S.R ............................... ..3/DIG. 3
`
`Primary Examiner-Richard A. Gaudet
`Assistant Examiner-Ronald L. Frinks
`Attorney-Burd, Braddock & Bartz
`
`ABSTRACT
`[5 7]
`A device and method for facilitating the rapid positive fixation
`of implanted prosthetic members in a living body. The device
`comprises a tubular sleeve of deformable material to which
`the prosthetic member is secured and which is capable of
`being expanded radially into intimate engagement with sur
`rounding'tissue. The ?xation device and prosthetic member,
`such as heart valve, vessel graft, etc., are prepared by as
`sembly prior to surgery. The assembly may be rapidly in
`troduced into the transplant situs during surgery and secured
`in place by expansion of the deformable sleeve by use of an ex
`pansion tool.
`
`3 Claims, 9 Drawing Figures
`
`NORRED EXHIBIT 2112 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
`
`

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`'
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`PATENTEUAPR 25 m2
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`‘ 3.657, 744
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`sum 1 or 2
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`AT TORNE-YS
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`NORRED EXHIBIT 2112 - Page 2
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`PATENTEDAPR 25 m2
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`,3, 557, 744
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`SHEET 2 OF 2
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`INVENTOR,
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`ATTORNEYS
`NORRED EXHIBIT 2112 - Page 3
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`1
`METHOD FOR FIXING PROSTIIETIC IMPLANTS INA
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`1 r. 3,657,744 '
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`'
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`‘
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`t LIVING BODY
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`I5
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`thrombi.
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`1
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`2
`‘ FIG. 3, is aperspective view of another modi?cation;
`FIG. 4 is a'pers’pective view of a furthermodi?cation;
`FIG. 5 is a schematic representation of a portion of . the
`This invention relates to a device and method for the rapid
`perimeter of any one of the devices of the preceding FIGS., as
`positive ?xation of implanted prosthetic members in a living 5
`seen in transverse section;
`‘
`'
`' being. Many thousands of implants of vprosthetic members,
`FIG. 6 is an elevation of one form of expanding tool which
`either arti?cial members or homografts or grafts from other
`may be utilized with the ?xation device;
`'
`'1
`animal species are made annually. Vessel grafts and heart
`FIG. 7 is a fragmentary elevation of the operating end of the
`valve implants are becoming commonplace. Transplantation
`expanding tool showing the tool in expanded condition;
`of large organs such as the heart, lungs, liver, etc. is taking 10
`FIG. 8 is a perspective elevational'view with the upper half _
`place in ever increasing numbers.
`of the ?xation device in section, and showing the ?xation
`The fixation device according to the present invention‘ com
`device with a heart valve attached for implantation; ‘and
`prises a tubular sleeve of deformable material to which the
`}
`. FIG. 9 is a top plan view of the assembly of FIG. 8. .
`prosthetic member is secured and which is capable of being
`Referring to the, drawings, and particularly to FIG. 1, there
`expanded radially into intimate engagement with the tissue
`is shown schematically one manner in which the prosthesis ?x
`surrounding the implant situs. It has been found through
`ation device according to the present invention is used. This
`animal experimentation that the implant may be made rapidly
`use is illustratedwith respect to the implantation of an arti?
`and positively, without fearof dislodgment or leakage; When
`cial bifurcated aortic Dacron graft,indicated generally at 10,
`formed of a compatible material, the ?xation device is well
`between the severed aorta 11, shown with a Satinsky clamp
`tolerated by the body and becomes completely covered by tis
`20
`Ipreventing flow,-and the common iliac arteries 13 and ‘'14. A
`sue leaving no exposed surface for the formation of clots and -'
`completed joint is shown between the artery' 13' and. one
`branch 15 of the arti?cial vesseltransplant. The ends of them
`tery and prosthesis are in butting relation held by an expanded
`?xation ‘sleeve, indicated generally at 16, within the' host'
`prosthesis junction.- A similar sleeve‘ 16 is shown partially
`within the branch 17 of the prosthesis 10 about to be con
`nected to the artery 14.
`The manner in which the junction is made is shown with
`respect to the severed end of the aorta 11. An expandable
`sleeve ?xation device 16 is shown extending from the end of '
`the arti?cial vessel graft 10 with about half of its length engag
`. ing the inside wall of the graft. The head .of an expander tool,
`indicated generally at 18, whose tubular barrel 19 extends
`through a slit 20 in the graft, is positioned within the sleeve. A ,
`tapered tip 21 placed onv .the end of the expanding tool
`facilitates entry of the assembled graft, tool and ?xation
`device 16 into the aorta. When in place, with the ends of aorta
`11 and graft 10' butting, the sleeve is expanded vby operation of
`the expanding tool to force the fenestrations of the sleeve into
`the wall of the aorta to achieve a leak-proof union and forcing
`the walls of the sleeve into tighter engagement with the inside
`wall of the graft“).
`’
`‘
`After "the sleeve is expanded, the tool is withdrawn. 'A
`smaller headed tool is inserted through slit 20 fromthe op- _
`45
`posite ‘direction to within the ?xation device '16 of lesser
`. diameter for connection with artery 14. The exposed end of
`sleeve 16 is inserted into the lumen of the artery 14 and the
`' sleeve is expanded to’make the joint. The tool is withdrawn,
`slit 20 is clamped shut and clamp 12 is removed to permit re
`50
`sumption of blood flow.'The entire transplant can be made in
`a matter of a very few minutes to the point of restoration of
`the blood supply. The longitudinal slit in the graft may then be
`sewn closed at leisure in con?dence that the blood is being
`supplied distal to the graft site.
`i
`'
`The tubular sleeve 16 is made of deformable material such
`that it retains , its expanded dimensions after expansion in
`place. It is formed from a non-toxic material compatible with
`blood and other body ?uids, such as stainless steel. Its walls
`desirably have a large percentage of open area so as to permit
`proliferation of the intima of the vessels through the openings
`and over the intervening strand-like or ribbon-like members.
`Preferably the openwork sleeve is formed from so-called “ex
`' panded metal’? sheeting which is produced by forming a series
`65
`of staggered parallel slits in an impervious metal sheet and
`then stretching the sheet in a direction perpendicular to the
`slits to open the slits into apertures and expand the metal sheet
`in that direction 'while contracting it slightly in the opposite
`' direction. The stretching operation by which the metal sheet is
`70
`expanded imparts a twist or bend to the undulating flat ribbon- _
`like portions 22 of the metal sheet separating the diamond
`shaped apertures 23 which are generally uniformly sized and
`distributed. This twisting or bending of the metal members 22
`between adjacent apertures imparts an angle or direction to
`the apertures themselves and to the ribbon-like members.
`
`According to the prior art, arti?cial heart valves are in
`stalled by the careful placing of a plurality of stitches around
`the rim of tissue that will house the valve. These'stitches are
`passed through a suture ring aroundthe outside of the heart
`valve. The valve to be implanted is held outside of the heart 6
`or 8 inches and each stitch is brought up through the suture ‘
`ring while the valve is still so held. When the sewing is
`?nished, the valve stands some distance above the heart and
`has 20 or 30 sutures going down to the tissue where it will
`?nally rest. The sutures are held tight and the heart valve is
`slid down them into place and each suture is then individually
`tied. This process takes 30 to 45 minutes in the best hands and
`from an hour to an hour and one-half in the less then best.
`‘
`In the case of the transplantation of a graft valve from
`another patient or from an animal, sewing takes more than an ‘
`hour. Although excellent results have been reported with
`these transplanted valves, few surgeons are using them today
`because of the great time that must be taken to sew them in.
`Valve installation takes place while the patient is on an arti?
`cial heart-lung machineand every minute is very important. -
`One form of prior art heart valve is available wherein a
`caged ball valve is provided in its outer rim with a plurality of
`radially. extending teeth which by screw means are caused to
`engage the aortic wall. Such valves, though expensive, are
`satisfactory where there is a veryv tight initial ?t and where the
`aortic wall _is_ of uniform consistency and size, conditions
`which cannot always be depended upon to exist. Accordingly,
`problems have arisen relating to aortic incompetence due to
`blood flow working its way between the prosthesis and the
`aortic wall in the many instances where no positive ?xation is
`achieved by the tooth members.
`The device of the present invention permits instant and
`positive ?xation of heart valves, vessel grafts and other
`prosthetic members. The valve or other prosthetic member is
`prepared for implantation by attachment to the openwork
`sleeve. The valve and its skirt composed of the sleeve is assem
`bled on an expanding tool device. This assembly can be
`quickly and‘ easily forced into place and the tubular sleeve ex
`panded to hold the valve or other member in place. This is
`done in a small fraction of the time required for other trans
`plants so that in many instances use of the heart-lung machine
`is not required. The ?xation sleeve expands so that a snug ?t is
`assured regardless of the size, shape or consistency of the tis
`sue wall at the implantation situs. Since the sleeve becomes in
`corporated into the tissue wall, no foreign material is left in
`contact with the blood, as opposed to prior art devices.
`The invention is illustrated by the accompanying drawings
`in which:
`'
`FIG. I is a schematic view showing three stages of the graft
`ing of an arti?cial bifurcation vessel graft utilizing the ?xation
`device according to the present invention; '
`FIG. 2 is a perspective schematic view of one modi?ed form
`of prosthetic ?xation device;
`
`.
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`NORRED EXHIBIT 2112 - Page 4
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`The expanded metal sheeting is desirably not ?attened prior
`to forming into a sleeve. The result, as seen schematically in
`FIG. 5, is that the ribbon-like portions 22 of the sleeve extend
`angularly relative to the perimeter of the‘ sleeve providing a
`multitude of narrow projecting edges which embed themselves
`into the tissue wall upon expansion of the sleeve. After being
`formed with ‘the members 22 extending generally longitu
`dinally, the sleeve is desirably spot welded to form a longitu
`dinal seam. The tubular sleeve may be circular, oval, or
`polygonal (hexagonal, octagonal or the like) in cross-section.
`The cross-sectional area may be uniform along the length of
`the sleeve or it may vary, giving the sleeve generally a barrel
`shape or that of a truncated cone. The edges may be cuffed if
`. desired or simply smoothed to facilitate entry. The sleeve may
`easily be expanded by about 50 percent beyond its original
`diameter. The sleeves are formed to be a size appropriate for
`the implant being made. The strands 22 and apertures 23 are
`sized proportionately.
`Because of the twisted relation of the ribbon-like portions of
`the sleeve, protrusion of the vessel lining is facilitated with the
`result that very little metal is actually in contact with the blood
`stream. Experimentally it has been determined that within a
`few seconds a ?ne clot layer is laid down over the stainless
`steel struts forming a physiological bridge from the islands of
`intima where the vessel lining protrudes through the apertures
`in the sleeve.
`Instead of metal, the tubular ?xation sleeve may be formed
`from other natural or synthetic materials having the requisite
`properties and- characteristics permitting the sleeve to be ex—
`panded into secure attachment with surrounding tissue.
`Desirably the material is one which is capable of being ab
`sorbed over an extended period of time by the tissue to which
`the sleeve is attached. A number of such absorbable materials
`are known.
`In the form of ?xation device shown in FIG. 2, sleeve 16A is
`provided with a plurality of circular holes 24 (which are of
`larger area than apertures 23) punched through the openwork
`wall around the sleeve adjacent one end to allow for the ostia
`of the coronary arteries.
`'
`In FIG. 3, a modi?ed form of sleeve 16B is provided with a
`plurality of relatively large rectangular openings 25 extending
`longitudinally to permit exposure of wide areas around the
`coronary artery ostia. This form of ?xation device is intended
`for the implantation of heart valves. The valve is hung with its
`commissures secured along the upper and lower ring portions
`26 and 27, respectively, whose widths are about one-eighth to
`one-fourth the length of the sleeve.
`In FIG. 4, the ?xation device includes a plurality of longitu
`dinal wire struts 28 separating two expandable and relatively
`narrow metal mesh ring sections 29 and 30. A three-pronged
`commissure valve is inserted in the upper expandable ring sec
`tion 29 and secured to the bottom mesh ring 30 circum
`ferentially.
`'
`A variety of expanding devices may be used to set the ?xa
`tion devices in place. One form of such tool is shown in FIG. 6.
`The device includes a pistol-grip handle 31 and a trigger-like
`operating lever 32 pivoted therein. An elongated tubular bar
`rel 19 extends out from the handle means. A concentric rod
`33 extends through the handle 31 and barrel 19 terminating in
`a ?tting 34 beyond the muzzle end of barrel 19 at its forward
`tip. Expansion means, comprised of a pair of resilient rings 35,
`I each held between a pair of washers 36 and held spaced apart
`by a rigid spacer ring 37, are disposed between the muzzle end
`of barrel l9 and tip ?tting 33. Operation of the lever 32 by
`gripping and squeezing to move it toward the handle causes
`rod 33 to shorten its exposed length in relation to barrel 19
`such that squeezing force causes the resilient rings to decrease
`their longitudinal dimensions. Being non-compressible, they
`expand radially outwardly increasing their lateral dimensions,
`as shown in FIG. 7. In this way, a predictable dependable
`amount of expansion can be achieved. The breech end of rod
`33 is threaded and ?tted with a knurled knob 38. The heel 39
`of operating lever 32 bearing against a spacer tube 40, which
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`NORRED EXHIBIT 2112 - Page 5
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`3,657,744
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`in turn bears against knob 38, causes the relative movement
`between barrel l9 and rod 33. Alternatively, force may be ex
`erted simply by rotation of knob 38 and adjustment of the at
`rest force exerted upon the expansion rings may be made.
`One, two or more expandable rings 35 may be used. The pat
`tern of expansion can be predetermined as desired by selec
`tion of appropriate spacing between those rings.
`When used for the installation of arti?cial vessel grafts
`made of Dacron, Te?on or similar arti?cial materials, the ?xa
`tion sleeve is attached to the vessel graft some timevprior to
`surgery and a longitudinal slit is made in the middle of the
`graft for the introduction of the expansion tool. At the time of
`surgery, the ends of the vessel to be grafted are secured
`through simple stay stitches or small clamps so that the ?xa
`tion sleeve can be introduced thereto. The expander tool is in
`place in one of the sleeves at the time of introduction. This
`sleeve is then expanded in situ andv the expander tool is
`removed through the longitudinal slit, turned around and used
`to expand the ?xation sleeve at the other end and again
`removed. The longitudinal slit is clamped and the clamps or
`stitches securing the vessels to be grafted are removed to
`restore the blood ?ow. Very rapid ?xation of vessel grafts is
`thus possible.
`_
`In FIG. 8 there is shown an aortic heart valve 45 in place in
`a ?xation sleeve 16. The rim of valve 45 adjacent the cusps 46
`is attached by sutures 47 to the sleeve near one end. A seg
`ment of the donor aorta 48 is attached by sutures 49 near the
`other end of sleeve 16. The opening 50 in the aorta wall for a
`coronary artery can be matched with the corresponding open
`ing in the wall of the donee aorta.
`When used for the ?xation of heart valves, whether a trans
`plant or arti?cial, the valve is secured within the ?xation
`sleeve prior to surgery and the sleeve is assembled in the ex
`pansion tool. Then, at the time of surgery, the sleeve is rapidly
`expanded into place and the tool withdrawn. When used for
`implantation of heart valves in the aortic position, a total in~
`troduction time of only a few minutes is necessary. This means
`that an aortic valve may be placed without use of a heart-lung
`machine. In?ow of blood into the heart is occluded by placing
`clamps across the appropriate vessels. A longitudinal slit (aor
`totomy) is placed in the aorta just a few centimeters above
`where it begins. This slit'is opened and the existing defective
`valve is removed. The new valve housed in the expandable
`sleeve is then placed in position and the sleeve is expanded in
`one stroke of the expanding tool. The expansion tool is then
`removed through the aortic slit and a clamp placed over it,
`thus allowing the restoration of blood ?ow so that only a few
`minutes total introduction time is required. The aortotomy
`can then be repaired at leisure after the heart has taken over
`its pumping function.
`It is apparent that many modi?cations and variations of this
`invention as hereinbefore set forth may be made without de
`parting from the spirit and scope thereof. The speci?c em
`bodiments described are given by way of example only and the
`invention is limited only by the terms of the appended claims.
`The embodiments of the invention in which an exclusive
`property or privilege is claimed are de?ned as follows:
`1. A method for rapidly and positively ?xing an inplanted
`prosthetic device in a living body which comprises:
`A. securing the prosthetic device to be implanted to at least
`one openwork tubular sleeve of non-toxic deformable
`material compatible with body ?uids and capable of being
`expanded radially, said sleeve being of a diameter-cor
`responding to the prosthetic member to be implanted and
`adapted for attachment to the prosthetic member, and in
`cluding a plurality of longitudinally extending ribbon-like
`undulating portions disposed angularly with respect to the
`perimeter of said sleeve and interconnected to de?ne a
`plurality of staggered closely spaced apertures,
`B. introducing the sleeve and prosthetic device into a
`prepared transplant situs, and
`"
`C. expanding the sleeve radially outwardly against the tissue
`walls of said situs and forcing the undulating ribbon-like
`
`

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`5
`portions of the sleeve into intimate engagement
`therewith, whereby the tissue may grow through and
`around the sleeve to cover the same.
`2. A method according to claim 1 further characterized in
`that:
`A. said prosthetic device to be implanted is a vessel graft,
`B. said openwork sleeve is inserted partially and secured in
`each end of said vessel graft leaving an exposed portion of
`sleeve extending therefrom,
`C. said graft is provided with a longitudinal opening to
`receive a sleeve expanding tool;
`D. said prosthetic device and sleeves are joined to the host
`vessels to be grafted by introduction of the exposed por
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`3,657,744
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`6
`tions of said sleeves into the severed host vessels, and
`E. the sleeves are expanded radially outwardly into intimate
`engagement with the walls of said vessels and said graft.
`3. A method according to claim 1 further characterized in
`that:
`A. said prosthetic device to be implanted is a heart valve,
`B. said valve is secured within one end of said sleeve,
`C. said sleeve and valve are introduced into the situs of the
`defective valve to be replaced, and
`D. said sleeve is expanded into engagement» with the sur
`rounding tissue.
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