United States Patent [19]
`Taheri
`
`[54] TECHNIQUE FOR AORTIC VALVE
`REPLACEMENT WITH SIMULTANEOUS
`AORTIC ARCH GRAFT INSERTION AND
`APPARATUS THEREFOR
`
`Inventor: Syde A. Taheri, 268 Dan Troy,
`Williamsville, NY. 14221
`
`Appl. No.: 752,336
`Filed:
`Nov. 19, 1996
`
`Related US. Application Data
`
`Continuation-in-part of Ser. No. 435,851, May 5, 1995,
`abandoned.
`
`Int. Cl.6 ................................ .. A61F 2/06; A61F 2/24
`US. Cl. .................................. .. 623/2; 623/1; 606/108
`Field of Search ..................... .. 623/2, 1, 12; 600/36;
`606/108, 198
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`USOO5824064A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,824,064
`Oct. 20, 1998
`
`5,571,172 11/1996 Chin .......................................... .. 623/1
`
`Primary Examiner—David H. Willse
`Attorney, Agent, or Firm—Lieberman & NoWak, LLP
`
`[57]
`
`ABSTRACT
`
`Transfemoral aortic valve replacement With the simulta
`neous insertion of an aortic arch graft, referred to as
`“TAVAG”, is effected With a device comprising the folloW
`ing components: a U-shaped collapsible nitinol ring Which is
`attached to a bioprosthetic valve, a thin Walled predeter
`mined graft With branches, a perforated self-expandable
`carrier capsule having a large slit therein, diamond shaped
`guide Wires, and a ring to control opening and closing of the
`carrier capsule. The graft and valve are pulled up from the
`left femoral artery toWard the aortic arch by pulling on the
`guide Wires Which are threaded through catheters inserted in
`each of the bilateral carotid and subclavian arteries toWard
`the left femoral artery. Cerebral circulation is also main
`tained from the right femoral artery through a novel balloon
`catheter placed inside the carotid artery.
`
`5,489,295
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`2/1996 Piplani et al. ............................ .. 623/1
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`7 Claims, 6 Drawing Sheets
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`VW
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`NORRED EXHIBIT 2118 - 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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`U.S. Patent
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`0a. 20, 1998
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`Sheet 1 of6
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`5,824,064
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`FIG 18
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`‘H' in‘ M \' \' \vj /
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`FIG. 1A
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`13
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`U.S. Patent
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`5,824,064
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`FIG. 2B
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`U.S. Patent
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`0a. 20, 1998
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`Sheet 3 0f 6
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`FIG. 5
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`U.S. Patent
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`0a. 20, 1998
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`Sheet 4 0f 6
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`FIG. 4A
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`FIG. 4B
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`U.S. Patent
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`0a. 20, 1998
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`Sheet 5 0f 6
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`U.S. Patent
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`0a. 20, 1998
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`Sheet 6 0f 6
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`5,824,064
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`

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`5,824,064
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`1
`TECHNIQUE FOR AORTIC VALVE
`REPLACEMENT WITH SIMULTANEOUS
`AORTIC ARCH GRAFT INSERTION AND
`APPARATUS THEREFOR
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`This invention is a continuation-in-part of prior applica
`tion Ser. No. 08/435,851, ?led on May 5, 1995 to the same
`inventor and is hereby expressly abandoned.
`
`10
`
`FIELD OF THE INVENTION
`
`This invention relates to a technique for repairing aortic
`dissection and in particular for the simultaneous insertion of
`an aortic valve and aortic graft in a patient’s ascending aorta,
`and to apparatus employed therefor.
`
`15
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`BACKGROUND OF THE INVENTION
`Heretofore, surgical techniques commonly employed for
`aortic arch aneurysm, particularly dissection of the thoracic
`aortic artery in response to aortic valve insu?iciency have
`evidenced a high incidence of mortality. This has been
`attributed to the complexity of the surgical procedure
`involved, the need for a multiplicity of blood transfusions
`and post operative complications. Accordingly studies have
`continued in the search for neW methods designed to obviate
`the foregoing limitations and to enhance the current tech
`nology.
`In accordance With the present invention, this end has
`been successfully attained by a novel technique using a
`procedure involving the use of a stented endovascular graft
`Which provides patients With an aortic arch graft With its
`branches simultaneously With the replacement of a biopros
`thetic aortic valve.
`
`SUMMARY OF THE INVENTION
`Transfemoral aortic valve replacement With the simulta
`neous insertion of an aortic arch graft, referred to as
`“TAVAG”, is effected With a device comprising the folloW
`ing components: a U-shaped collapsible nitinol ring Which is
`attached to a bioprosthetic valve, a thin Walled predeter
`mined graft With branches, a perforated self-expandable
`carrier capsule having a large slit therein, diamond shaped
`guide Wires, and a ring to control opening and closing of the
`carrier capsule. The graft and valve are pulled up from the
`left femoral artery toWard the aortic arch by pulling on the
`guide Wires Which are threaded through catheters inserted in
`each of the bilateral carotid and subclavian arteries toWard
`the left femoral artery. Cerebral circulation is also main
`tained from the right femoral artery through a novel balloon
`catheter placed inside the carotid artery.
`
`35
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`BRIEF DESCRIPTION OF THE DRAWING
`The invention Will be more fully understood by reference
`to the folloWing detailed description taken in conjunction
`With the accompanying draWing Wherein:
`FIG. 1(a) is a front elevational vieW of a self-expandable
`carrier capsule of variable siZe and length, in the open
`position, adapted With a large slit for branches of a prosthetic
`graft;
`FIG. 1(b) is a front elevational vieW of the capsule shoWn
`in FIG. 1 in the closed position;
`FIG. 2(a) is a frontal vieW in perspective of a U-shaped
`collapsible metal frame seWn to a prosthesis Which is in turn
`seWn to a collapsible bioprosthetic valve or a Xenograft
`valve;
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`55
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`65
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`FIG. 2(b) is a frontal vieW of the structure of FIG. 2(a) in
`the closed position.
`FIG. 3 is a front elevational vieW of a pressure controlled
`paddle shaped in?atable bar or eXternal stent employed in
`the practice of the present invention;
`FIG. 4(a) is a frontal vieW in perspective of a pressure
`controlled internal single donut shaped stent employed in the
`practice of the present invention;
`FIG. 4(b) is a frontal vieW in perspective of a pressure
`controlled internal double donut shaped stent employed in
`the practice of the present invention;
`FIG. 5 is a frontal vieW of a double lumen guide Wire
`stapling catheter employed in the practice of the present
`invention;
`FIG. 6 is a frontal vieW of the anatomy of an aortic arch;
`FIG. 7(a) is a frontal vieW in perspective of a purse string
`guide Wire or suture prior to activation of the purse string;
`FIG. 7(b) is a frontal vieW in perspective of the device of
`FIG. 7(a) after activation of the purse string, and
`FIG. 8 is a frontal vieW, in perspective of a shunting
`catheter Which provides cerebral circulation during a surgi
`cal procedure.
`
`DETAILED DESCRIPTION OF INVENTION
`
`With reference noW more particularly to FIG. 1, there is
`shoWn a capsule 11 of variable siZe and length having an
`opening 13 through Which branches of a prosthetic graft Will
`eXtend. Opening and closing of capsule 11 is effected by
`motion of ring 16 Which is effected by pulling and pushing
`on guide Wire 17, or other mechanical means. FIG. 1(a)
`depicts capsule 11 in the open position and FIG. 1(b) depicts
`capsule 11 in the closed position.
`FIG. 2(a) is a frontal vieW in perspective of a collapsible
`interconnected multiple U-shaped metal frame in the open
`position comprising a stainless steel or nitinol thin Wire
`U-shaped metal frame 21, typically 2 mm in diameter and 15
`mm in length, seWn to a prosthesis 22 comprising either
`DACRON or GORTEX, both of Which are brands of resil
`ient polyester teXtile ?bers. Frame 21 is seWn to a collapsible
`valve 23 Which may be a bioprosthetic or a Xenograft valve.
`FIG. 2(b) depicts the structure of FIG. 2(a) in the closed
`position.
`With reference noW to FIG. 3, a frontal vieW of a human
`chest cavity shoWing the use of an eXternal stent in accor
`dance With the invention is depicted. This device is similar
`to pillars in the front of a dWelling home. The device
`includes tWo large cushions 30 and 31 Which cushion or
`paddle the ascending arch of the aorta. The cushions are
`connected by means of a semi rigid tubing 32 to Which is
`connected tubing 33. The device is pressuriZed and con
`trolled by an outside bulb 34 Which in?ates the cushions and
`Which has a pressure control valve or gauge 35 to maintain
`the stent pressure at a level equal to the systemic pressure.
`The stent is inserted via the thoracoscopy approach in the
`thoracic cavity 36 via a chest port and thoracoscopy visu
`aliZation. The device is directed to the pleural cavity and
`cushions are directed toWard the ascending aorta and chest
`Wall Where they Will be in?ated to systemic pressure.
`Cushions 30 and 31 typically comprise silicone rubber.
`Tubing 32 is a holloW column tubing is semi rigid and may
`range from 30 to 35 cm. in length and from 8—12 mm. in
`Width.
`FIG. 4(a) is a frontal vieW in perspective of an internal
`stent in accordance With the invention. This ?gure shoWs a
`single or donut shaped balloon 41 Which is connected by a
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`silicone tube 42 to the shaft of a catheter 43. FIG. 4(b) shows
`a single or double donut shaped balloon 44 Which is con
`nected to a catheter 45 by means of silicone cylinder 46,
`typically 20—30 mm. in Width and 1.0—1.5 cm. in height. The
`internal stent is inserted into the aorta via the femoral artery
`and lodged in the predetermined dissected site of the ascend
`ing aorta by in?ating the donut shaped balloon against the
`torn aorta Wall With the simultaneous outside pressure from
`the external stent, thereby preventing bleeding through the
`dissected point.
`FIG. 5 is a frontal vieW of a double lumen guide Wire
`stapling catheter employed in the practice of the present
`invention. ShoWn in the ?gure is a guide Wire lumen 51,
`stapling carrying lumen 52 comprising a rectangular shaped
`tubing having a track 53 on each side thereof to alloW a
`staple 54 to move doWnWard to a desired location in a blood
`vessel. Plunger 55 is used to dislodge the staple at the
`conclusion of surgery. This device may also be used as an
`intervascular angiography catheter.
`FIG. 6 is a frontal vieW of the anatomy of an aortic arch.
`ShoWn in the ?gure is femoral artery 61, left subclavian
`artery 62, left common carotid artery 63, ascending aorta 64,
`right carotid artery 65, right subclavian artery 66 and heart
`67. In the practice of the invention, the graft of interest is
`brought from the femoral artery 61 in the groin to the arch
`of the aorta 64. This end is attained by means of a guide Wire
`originating in a designated location in the subclavian arteries
`or carotid arteries Which is directed toWard the groin and
`passed through the respective branch of a graft to be inserted
`in that artery and returned via the same catheter to the
`subclavian region by pulling the guide Wire. This permits the
`surgeon to bring the graft and the collapsible valve, if any,
`from the groin to the ascending aorta. FolloWing intervas
`cular graft suturing or stenting to a designated artery, the
`guide Wire and balloon catheter are removed and the arte
`riotomy is closed.
`FIG. 7(a) is a frontal vieW in perspective of a purse string
`guide Wire or suture prior to activation of the purse string
`Which is suitable for use in the practice of the present
`invention. This device is a retriever and includes catheter 71
`having guide Wire 72 disposed therein and passing
`therethrough, guide Wire 72 being attached to a purse string
`guide Wire or suture 73 having a proximal ring 74 at the top
`end thereof. As the guide Wire is pulled doWn, the proximal
`ring is approximated and separated from the aortic Wall,
`thereby permitting the surgeon to retrieve or place it in a
`different location under direct observation utiliZing an
`angioscope. FIG. 7(b) is a frontal vieW in perspective of the
`device of FIG. 7(a) after activation of the purse string.
`FIG. 8 is a frontal vieW, in perspective, of a shunting
`catheter for providing cerebral circulation during surgery.
`ShoWn in this FIG. is a balloon shunting catheter 81 includ
`ing balloon 82 inserted internally in carotid artery 83. Also
`shoWn is an aperture 84 disposed Within catheter 81 for
`supplying blood to the patient’s brain during the surgical
`procedure. The catheter draWs blood to the patient’s brain
`from the patient’s right femoral artery, and blocks off blood
`?oW through the carotid artery While the surgeon operates in
`that region to repair an aneurysm. Use of this balloon
`catheter obviates the need for an external mechanical means
`for providing circulation to the patient’s brain.
`The present invention is described in terms of its preferred
`embodiments. HoWever, it Will be understood that these
`embodiments are set forth for purposes of exposition only
`and are not to be construed as limiting. The numbering
`sequence employed in referencing device elements is con
`sistent in each ?gure.
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`4
`The invention Will be further described by reference to a
`typical exemplary embodiment in Which a patient afflicted
`With an aortic aneurysm With or Without an aortic valve
`insufficiency, is treated With the placement of a graft, and an
`aortic valve When appropriate. Depending on Where the
`location of the aneurysm, the graft Will have branches
`corresponding to the right and left, subclavian and carotid
`arteries. The ?rst step in the surgical event involves exposing
`and dissecting the bilateral subclavian, carotid and left
`femoral arteries of the patient. Each of the dissected arteries
`is individually catheteriZed toWard the left femoral artery. A
`guide Wire is inserted in each of the catheters and directed
`toWard the distal end of the catheters Which have been
`placed inside the opening of the left femoral artery. In one
`preferred embodiment the guide Wires are diamond tipped so
`as to alloW easier passage through the graft. Each of the
`guide Wires are passed through the respective branches of
`the prosthetic aortic graft and tied doWn to the graft. In one
`embodiment the guide Wires are tied to threads Which extend
`from the branches of the graft. The distal end of the guide
`Wires are brought back through their respective catheters to
`the previously dissected artery and outside the patient’s
`incision.
`The graft is placed Within a capsule of the type shoWn in
`FIGS. 1(a) and 1(b). The capsule has a ring 16 Which is
`attached to some mechanical means including a stiff guide
`Wire for opening and closing the capsule. In one preferred
`embodiment the capsule is placed Within the open left
`femoral artery With its opening facing the patient’s head and
`tWo stiff guide Wires attached to ring 16 trailing outside the
`incised femoral artery. The capsule is closed by pushing on
`the stiff guide Wires and raised toWard the aorta by pulling
`on the guide Wires passing through the graft. At the aorta the
`graft is released from the capsule by pulling on the stiff
`guide Wires thereby opening the capsule. By gently pulling
`on the guide Wires passing through the branches of the graft,
`the graft is directed to the respective branches of the aorta.
`At this point, an arch arteriogram is performed and the guide
`Wires and catheters are removed. The side branches of the
`graft are then sutured, or by endovascular stenting tech
`niques are secured in place, and lastly, the arteriotomy and
`skin incisions are closed.
`Oftentimes, patient’s With aortic aneurysms also suffer
`from aortic valve insufficiency. Consequently, it is often
`desirable to replace the aortic valve When repairing an aortic
`aneurysm. The method of the present invention as described
`above can be advantageously employed, together With a
`novel prosthetic aortic valve described beloW, to simulta
`neously repair an aortic aneurysm and replace an insuf?cient
`aortic valve. The valve used in accordance With the present
`invention is a collapsible interconnected multiple U-shaped
`metal frame comprised of stainless steel or nitinol thin Wire
`and seWn to a bioprosthetic or a xenograft valve, typically 20
`mm to 30 mm in diameter, 1 mm to 10 mm in length and 3
`mm to 4 mm in thickness. The valve is seWn to the prosthetic
`graft used to repair the aortic aneurysm. The valve is
`introduced into the patient and maneuvered into place
`together With the prosthetic graft. During the procedure
`hoWever, prior to maneuvering the graft into place, a ?ber
`optic laser is introduced into the right subclavian artery to
`pulveriZe the existing damaged aortic valve. Thereafter, the
`prosthetic aortic valve is released from the expandable
`capsule by proximal pulling of the ring structure shoWn in
`FIG. 1, and secured to the ascending aorta Wall.
`When one of the branches of the graft corresponds With a
`carotid artery, one preferred embodiment of the present
`invention establishes carotid artery circulation With an inter
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`nal carotid shunt or a double lumen shunting balloon cath
`eter of the type shoWn in FIG. 8, as previously explained.
`In the case of an unstable patient, it is preferred to place
`a percutaneous transaortic stent in the ascending aorta prior
`to any arterial exposure. In one advantageous embodiment
`of the present invention, a transaortic stent balloon catheter
`as shoWn in FIG. 4b, is placed at the site of the dissection
`Within the aorta. The internal stent is donut shaped and
`connected to a silicone cylinder 20—30 mm Wide and 10—15
`cm long. It is inserted into the aorta via the femoral artery
`and lodged in the dissected site of the ascending aorta. By
`in?ating the donut shaped balloon against the torn aorta Wall
`from Within the aorta and exerting outside pressure from an
`external stent as shoWn in FIG. 4, bleeding through the
`aneurysm is prevented.
`The described technique is a novel concept Which pro
`vides a safe and practical approach to a complex disorder.
`The technique reverses abnormal hemodynamics to normal
`circulation and by utiliZing an aortic arch graft bypasses the
`dissected thoracic aorta. Consequently, this obviates the
`need for further dissection and establishes distal circulation
`to a predissected condition. Experience has revealed that this
`type of surgical procedure Will successfully result in saving
`the lives of many thousands of patients from this disease.
`It Will be understood by those skilled in the art that
`variations may be made Without departing from the spirit
`and scope of the invention. Thus, for example, the collaps
`ible valve employed herein may be either a human valve
`(bioprosthetic) or an animal valve (xenograft) and the mate
`rial comprising the U-shaped collapsible frame may be
`stainless steel or nitinol thin Wire.
`Additionally, it may be expedient to employ an intervas
`cular tWister in the practice of the present invention. This
`device Which is unique may be introduced into a blood
`vessel from a distant location to seiZe a graft and tWist it to
`yield either a large graft or a small graft of limited diameter.
`This permits the surgeon to pass into small arteries or affords
`the opportunity to seiZe the proximal part of a graft and tWist
`it to push it forWard toWard the aortic arch.
`What is claimed is:
`1. A method for repairing an aortic aneurysm in a patient,
`With a prosthetic aortic graft, said prosthetic aortic graft
`having one or more branches corresponding to one or more
`of the left subclavian, right subclavian and carotid arteries,
`one branch corresponding to one artery, said method com
`prising the steps of:
`exposing and dissecting one or more of said left
`subclavian, right subclavian and left carotid and right
`carotid arteries, and said patient’s left femoral artery;
`catheteriZing each of said exposed subclavian and carotid
`arteries;
`a ?rst threading of a ?rst end of a guide Wire through each
`of said catheters in each of said exposed subclavian and
`carotid arteries toWard and through said exposed, dis
`sected femoral artery, each of said catheters having a
`different guide Wire threaded therethrough, While main
`taining a second end of each of said guide Wires at said
`exposed, dissected subclavian and carotid arteries;
`the second threading of each of said ?rst ends of said
`guide Wires through the branch in said prosthetic aortic
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`graft and back through the catheter toWard said
`exposed, dissected subclavian and carotid arteries cor
`responding to the artery through Which said guide Wire
`Was ?rst threaded, While anchoring each of said guide
`Wires to their respective branches;
`placing said prosthetic aortic graft into an openable and
`closeable capsule;
`draWing said prosthetic aortic graft in said capsule from
`said femoral artery toWard said patient’s aortic arch by
`pulling on said ?rst and second ends of said guide
`Wires;
`aligning each of said branches of said prosthetic aortic
`graft With said corresponding artery by pulling on the
`appropriate one of said guide Wires;
`securing said prosthetic aortic graft to said patient’s aortic
`Wall;
`removing said catheters and guide Wires; and
`closing and covering said dissected, exposed arteries.
`2. A method according to claim 1 Wherein said securing
`step includes suturing said prosthetic aortic graft to said
`patient’s aortic Wall.
`3. A method according to claim 1 Wherein said securing
`step includes stenting.
`4. A method according to claim 1 Wherein aortic valve
`replacement is to be performed simultaneously With the
`repairing of the aortic aneurysm, further comprising the
`steps of:
`securing a prosthetic aortic valve to said prosthetic graft;
`pulveriZing said patient’s aortic valve prior to securing
`said graft to said patient’s aortic Wall; and
`securing said prosthetic aortic valve and said prosthetic
`graft to said patient’s aortic Wall, simultaneously.
`5. A method in accordance With claim 1 Wherein said
`prosthesis comprises a material selected from the group
`consisting of DACRON and GORTEX.
`6. A method according to claim 1 further comprising the
`steps of:
`inserting an external stent in the thoracic cavity via a chest
`port, said external stent having ?rst and second cush
`ions separated by a semi-rigid tubing therebetWeen and
`an in?ator tube connected at one end inside the thoracic
`cavity to said semi-rigid tube and connected at an
`opposite end outside said thoracic cavity to a bulb and
`gauge for in?ating said cushions to the systemic pres
`sure;
`in?ating said external stent;
`inserting an internal stent through a femoral artery, said
`internal stent having an in?atable donut shaped balloon
`Which is connected by a silicone tube to a shaft of a
`catheter
`lodging said internal stent at an aortic dissection; and
`in?ating said donut shaped balloon against the aortic
`dissection from Within the aortic arch and directly
`opposite to the external stent.
`7. A method in accordance With claim 6 Wherein the
`prosthetic aortic valve is selected from the group consisting
`of bioprosthetic valves and xenograft valves.
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