United States Patent [191
`Dotter
`
`[11] Patent Number:
`[45] Date of Patent:
`
`4,503,569
`Mar. 12, 1985
`
`[54] TRANSLUMINALLY PLACED
`EXPANDABLE GRAFT PROSTHESIS
`[76] Inventor:
`Charles T. Dotter, 4004 SW.
`GreenleafDr., Portland, Oreg. 97221
`[21] Appl‘ NOJ 471,856
`
`4,299,226 11/1981 Banka ............................ .. 128/325 X
`4,300,244 11/1981 Bolcros
`............ .. 3/1.4
`4,315,509 2/1982 Smit .................. ..
`128/303 R
`
`FOREIGN PATENT DOCUMENTS
`260819 10/1970 U.S.S.R. ............................... .. 3/1 A
`
`Primary Examiner-Ronald L. Frinks
`g’igzfyilgff“ 0’ F’""_W°°da‘d’ We‘km’ Emha’d‘
`g
`
`Mar. 3, 1983
`[22] Filed:
`[51] Int. c1.3 ........................ .. A61F 1/00; A61F 1/24;
`A61B 17/00
`[52] U.S. Cl. .............................................. .. 3/1.4; 3/1;
`128/303 R; 128/334 R; 128/343; 128/325,
`604/8
`[5 8] Field of Search ............................. .. 3/1, 1 A, 1.4;
`123/334 R, 325, 303 R, 3031, 30341, 30342,
`343; 604/8
`
`[56]
`
`[57]
`ABSTRACT
`_
`_
`A translummally placed endovascular graft prosthesls
`includes a helically Wound Coil having a generally tubu
`lar shape and is made of a shape memory Nitinol alloy
`having a transition temperature in the range of
`115°-125° F. After placement within a body blood ves
`_
`sel and upon heating of the, prosthesis to its transition
`References Cited
`temperature, the prosthesis expands so as to become
`U.S. PATENT DOCUMENTS
`3,657,744 4/1972 Ersek .................................... .. 3/1 A ?rmly anchmed 1° the inside Wall Of the body blood
`3,713,175 1/1973 weisman
`3/14 X vessel. After expansion the diameter of the lumen of the
`3,827,426 8/1974 Page et a1
`....... .. 3/1
`prosthesis is approximately equal to the diameter of the
`1?;
`113411161’ e1 alt
`- -
`~ body blood vessel passageway. The prosthesis may also
`
`- -
`
`.
`.
`ergentz e a.
`,
`,
`. . . . .. 3/1.4
`4,130,904 12/1978 Whalen . . . . . . .
`. 3/ 1.4 X
`4,140,126 2/1979 Choudhury
`4,183,102 1/ 1980 Guiset .................................... .. 3/1 4
`
`-
`be used 1“ other body passageways‘
`
`14 Claims, 7 Drawing Figures
`
`Edwards Exhibit 1009, p. 1
`
`

`

`US. Patent Mar. 12,1985
`
`Sheetlof2
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`4,503,569
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`‘
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`FIG. 2'
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`Edwards Exhibit 1009, p. 2
`
`

`

`U.S. Patent Mar. 12,1985
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`.Sheet2of2
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`4,503,569
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`FL
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`A' _
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`Edwards Exhibit 1009, p. 3
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`

`

`1
`
`4,503,569
`
`TRANSLUMINALLY PLACED EXPANDABLE
`GRAFI‘ PROSTHESIS
`
`5
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`0
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`5
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`25
`
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The present invention relates generally to the ?eld of
`prosthetic devices for use within a body passageway or
`duct and, more particularly, to the area of translumi
`nally placed endovascular grafts prosthesis which are
`particularly useful for repairing blood vessels narrowed
`or occluded by disease.
`2. Description of the Prior Art
`Transluminal endovascular grafting has been demon
`strated by experimentation to present a possible alterna
`tive to conventional vascular surgery. Transluminal
`endovascular grafting involves the percutaneous inser
`tion into a blood vessel of a tubular prosthetic graft and
`its transluminal catheter placement at the desired loca
`tion within the vascular system. Advantages of this
`method over conventional vascular surgery include
`obviating the need for surgically exposing, incising,
`removing, replacing or bypassing the defective blood
`vessel.
`Despite the major advantages afforded by translumi
`nal endovascular graft placement, this method inher
`ently presents certain problems. During placement the
`graft prosthesis must be smaller than the lumen of the
`blood vessel through which it is moved by a catheter
`into the desired location. Since the lumen of the initially
`narrowed segment of blood vessel should, after graft
`placement, be approximately equal to that of the adja
`cent undarnaged portions, it is necessry that the graft be
`increased in diameter after placement.
`Another problem concerns the possible migration of
`the graft after placement at a desired location. Thus, the
`graft must be provided means for permanently anchor
`ing in place.
`Through previous experimentation, I have shown
`that the use of an expandable tubular coilspring prosthe
`40
`sis provides means for controlling the size of the pros
`thesis to facilitate placement and anchoring. The use of
`such a prosthesis was described in my following publi
`cation: Dotter, C. T.: TransIuminally-placed Coilspring
`Endarterial Tube Grafts, Investigative Radiology, Vol.
`4, No. 5, Sept-Oct, 1969. As disclosed in this publica
`tion, the coilspring endovascular prosthesis can be ei
`ther stretched out or wound up and hooked to a con
`trolling mandrel so as to reduce the diameter of the
`prosthesis for easier introduction and placement. After
`placement and upon externally-effected release from
`the mandrel, the coilspring prosthesis automatically
`expands to provide a larger lumen and better anchoring
`at the site of placement.
`The use of spring force to expand the diameter of a
`coilspring prosthesis after vascular placement presents a
`disadvantage to the degree that is unnecessarily compli
`cates the grafting procedure, requiring increased skill of
`the physician in effecting implantation and also requir
`ing a fairly complicated mechanism to effect external
`release from the mandrel. Thus, it would be desirable to
`employ a simpler method for externally controlling the
`diameter of the prosthesis within the body.
`One type of graft prosthesis which is expandable
`within a blood vessel is disclosed in U.S. Pat. No.
`4,140,126 to Choudhury. This refers to an elongated
`tube having a plurality of longitudinal folds interspaced
`with a plurality of radially spaced anchoring pins and
`
`65
`
`45
`
`50
`
`60
`
`2
`mounted upon upper and lower expansion rings. The
`elongated tube is mechanically expanded by release of
`the upper and lower expansion rings. This device is
`characterized by a relatively complicated mechanical
`means for expanding the prosthesis within the blood
`vessel and is not adaptable for use as a prosthetic graft
`to repair an occluded segment of a blood vessel.
`U.S. Pat. No. 4,130,904 to Whalen discloses a pros
`thetic blood conduit which includes a helically formed
`coil. The device is otherwise different than the present
`invention and is not adapted for implantation within an
`occluded blood vessel.
`U.S. Pat. No. 3,713,175 to Weisman discloses a co
`balt-chromium-tungsten-nickel-molybdenum alloy car
`diovascular implant device. The allow is not disclosed
`to have shape memory properties and the implant is not
`temperature expandable for implantation purposes.
`U.S. Pat. No. 4,159,719 to Haerr and U.S. Pat. No.
`4,183,102 to Guiset both disclose devices which are
`expandable within a body duct, but are otherwise differ
`ent from the present invention.
`Accordingly, it is an object of the present invention
`to provide an improved graft prosthesis for therapeutic
`use within a body passageway or duct.
`It is a further object of this invention to provide a
`prosthetic graft which is temperature expandable for
`opening or repairing body passageways or ducts, but
`which is inert to normal body temperature ?uctuations.
`These and other objects and advantages of the pres
`ent invention will be apparent from the following de
`scription.
`SUMMARY OF THE INVENTION
`One embodiment of the present invention is charac
`terized by a graft prosthesis which is useful for place
`ment within a body passageway. The prosthesis is an
`open-ended tube which is expandable from a ?rst con
`?guration sized for transluminal placement within the
`body passageway to a second con?guration having an
`outer diameter which is larger than‘ the body passage
`way. The device is formed of a shape memory alloy
`with a transistion temperature at or above normal body
`temperature but within bodily tolerance. After place
`ment and upon heating to the approximate transition
`temperature the graft expands radially so as to expand
`the diameter of the lumen and become ?rmly anchored
`in the body passageway.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIGS. 1 and 2 are‘ enlarged elevation views of the
`expandable graft prosthesis of the present invention in
`its initial and expanded con?guration, respectively.
`FIGS. 3-6 are enlarged fragmentary cross~sectional
`views showing successive steps in the implantation of
`the temperature expandable graft prosthesis of the pres
`ent invention within a narrowed segment of a body
`blood vessel.
`FIG. 6A is an enlarged fragmentary cross-sectional
`view showing an alternative preferred embodiment of
`the guide catheter of the present invention having a
`catheter balloon thereon to prevent too quick wash
`away or thermodilution of the hot saline solution used
`to trigger expansion of the graft prosthesis of the pres
`ent invention.
`
`Edwards Exhibit 1009, p. 4
`
`

`

`3
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`For the purposes of promoting an understanding of
`the principles of the invention, reference will now be
`made to the embodiment illustrated in the drawings and
`speci?c language will be used to describe the same. It
`will nevertheless be understood that no limitation of the
`scope of the invention is thereby intended, such alter
`ations and further modi?cations in the illustrated de
`vice, and such further applications of the principles of
`the invention as illustrated therein being contemplated
`as would normally occur to one skilled in the art to
`which the invention relates.
`Referring now to the drawings, FIG. 1 shows the
`temperature expandable graft prosthesis of the present
`invention generally designated as 10. Prothesis 10 is a
`generally tubular shaped coil of wire having a number
`of helical turns llaProsthesis 10 is made from a shape
`memory Nitinol alloy with a transition temperature in
`the range of 115-125 degrees Fahrenheit. Those skilled
`in the art will appreciate that the transition temperature
`of the Nitinol family of alloys can be manipulated over
`a wide range by altering the nickel-titanium ratio, by
`adding small amounts of other elements, and by varying
`deformation and annealing processes, therefore, no fur
`ther description of the composition of the shape mem~
`ory Nitinol alloy is necessary.
`It is to be appreciated that FIG. 1 shows prosthesis 10
`in a con?guration which renders it suitable for tran
`sluminal insertion within a blood vessel or other body
`passageway. Thus, in the con?guration shown in FIG.
`1, prothesis 10 has an outer diameter 12 which is less
`than the corresponding diameter of the blood vessel
`lumen. FIG. 2 shows prosthesis 10 in the large diameter
`con?guration it would be caused to assume after place
`ment within a narrowed segment of a blood vessel lu
`men. In this expanded con?guration, prosthesis 10 has
`an inner diameter 13 which is approximately equal to
`that of the adjacent relatively normal portions of the
`blood vessel. In the expanded con?guration, prosthesis
`10 is longitudinally contracted relative to its FIG. 1
`con?guration.
`In order to form the prosthesis 10 so that it will as
`sume the position shown in FIG. 2 when heated to its
`transition temperature, a length of Nitinol alloy wire is
`coiled around a mandrel at room temperature so that it
`has the large diameter con?guration shown in FIG. 2.
`In a manner well known in the art, the wire is then
`heated until its crystal structure assumes its high-tem
`perature austenite con?guration also known as the beta
`or parent phase. Next, the wire is cooled so that the
`atomsin the metal rearrange themselves into a crystal
`structure known as martensite. The coil wire may now
`be bent and extended into the relatively smaller diame
`ter con?guration shown in FIG. 1. Because the coil
`wire is formed of a Nitinol alloy material, it will revert
`to the large diameter con?guration shown in FIG. 2
`when the prosthesis 10 is later heated to a temperature
`at which the crystal structure reverts to the parent
`phase. Prosthesis 10 will retain this shape unless it is
`cooled below a temperature at which martensite trans
`formation of the Nitinol alloy occurs. Since this trans
`formation only begins at temperatures well below nor
`mal vbody temperature, prosthesis 10 cannot return to
`65
`the unexpanded con?guration shown in FIG. 1. The
`open coil spring con?guration shown in FIG. 2 permits
`prompt ?rboblastic envelopment and the rapid forma
`
`4,503,569
`4
`tion of a new, ?rmly'anchored, autogenous lining sur
`face, thereby favoring continued patency of prosthesis
`10 within a body blood vessel. While a helical coil con
`struction is favored for this reason, it should be under
`stood that other constructions may also be employed
`without departing from the spirit and scope of the in
`vention.
`Referring now to FIGS. 3-6, successive steps in the
`percutaneous transluminal placement of prosthesis 10
`within a partially occluded segment of a blood vessel
`passageway are depicted. As seen in FIG. 3, a conven
`tional catheter 16 is percutaneously inserted into blood
`vessel lumen 17. This step may be accomplished using
`normal catheterization techniques. Distal end 19 of
`catheter 16 is then moved into a position near the nar
`rowed segment 20 of blood vessel lumen 17. As shown
`in FIGS. 4 and 5, prosthesis 10 in its unexpanded con?g
`uration corresponding to that seen in FIG. 1 is pushed
`over the end of inner guide catheter 21 into a recessed
`segment 26 at the end of inner guide catheter 21 where
`it is securely held while being passed by external manip
`ulation of guide catheter 21 through and beyond cathe
`ter 16 to the desired site of placement in the narrowed
`segment 20 of blood vessel lumen 17.
`_
`In order to expand prosthesis 10 within narrowed
`segment 20 of blood vessel lumen 17, it is necessary to
`heat prosthesis 10 to a temperature at which the Nitinol
`alloy composing prosthesis 10 reaches its transition
`temperature and austenite transformation occurs
`(ll5-125 degrees Fahrenheit). This is accomplished by
`injecting a hot ?uid through the lumen of guide catheter
`21 so as to bathe and trigger expansion of prosthesis 10.
`It has been determined that a saline solution having a
`temperature in the range of 130-135 degrees Fahrenheit
`is acceptable for this purpose. Guide catheter 21 has a
`series of side apertures 22 positioned along the portion
`of its length that accommodates prosthesis 10. Aper
`tures 22 serve as the exit points for the injected saline
`solution, and the tip 23 of guide catheter 21 is closed so
`that ?uid only exits through the side apertures.
`In applications involving the repair of narrowed
`blood vessel segments it should also be mentioned that
`means may be taken to prevent too quick wash away or
`thermodilution of the hot saline. Such means could be as
`simple as applying pressure over the blood vessel and
`above or below graft, thereby stopping blood ?ow
`through the vessel during graft expansion. FIG. 6A
`depicts the use of guide catheter 21 modi?ed to include
`a catheter ballon 24 thereon which is positioned imme
`diately downstream of prothesis 10 on guide catheter
`21. An additional series of apertures 25 are provided in
`guide catheter 21 for ?uid communication into balloon
`24. Triggering of prosthesis 10 by hot saline injected
`through guide catheter 21 will therefore expand balloon
`24 and stop any ?ow through the blood vessel while at
`the same time bathing prosthesis 10 with hot saline to
`trigger its expansion. It is to be understood that while
`balloon 24 is shown in the distended position it would
`assume upon injection of the hot saline, balloon 24
`would be in a collapsed position during insertion of
`guide catheter 21 within the blood vessel. Alternatively,
`balloon 24 could be positioned on the upstream side of
`prosthesis 10 or even both sides if such becomes desir
`able for any reason.
`As the Nitinol alloy in prosthesis 10 reaches its transi
`tion temperature (125-130 degrees Fahrenheit) it
`promptly reassumes the large diameter con?guration
`shown in FIG. 2. Once this expanded con?guration is
`
`60
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`40
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`45
`
`Edwards Exhibit 1009, p. 5
`
`

`

`15
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`20
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`4,503,569
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`6
`attained as seen in FIG. 6, it becomes possible to with
`sion of said member also expanding the diameter of
`draw guide catheter 21, thereby leaving prosthesis 10
`said lumen.
`securely locked by outward pressure against the blood
`2. The apparatus of claim 1, wherein said tubular
`'
`shaped member is a helically wound coil spring.
`vessel wall.
`3. The apparatus of claim 1, wherein said shape mem
`It is to be understood that other means and methods
`for placing prosthesis 10 within a narrowed blood vessel
`ory material is a Nitinol alloy.
`V
`4. The apparatus of claim 3, wherein said Nitinol
`segment may occur to persons normally skilled in the
`alloy has a transition temperature in a range between
`art and the invention is not restricted to the catheter
`115-125 degrees Fahrenheit.
`introduction and placement system described herein.
`5. The apparatus of claim 1, wherein the diameter of
`For instance, by the choice of an appropriately charac
`said lumen in its expanded position is approximately
`terized Nitinol or other shape-memory alloy, arti?cially
`equal to the diameter of the passageway of said body
`elevated or normal body temperature can be used to
`blood vessel.
`cause a desired change in con?guration of a percutane
`6. The apparatus of claim 1, wherein said transition
`ously placed body prosthesis. In order to use normal
`temperature is in the range of 115-125 degrees Fahren
`body temperature, a straight length of Nitinol or other
`heit.
`type of prestressed shape-memory alloy wire having a
`7. A graft prosthesis for placement within a body
`transistion temperature of 98.6" F. can be inserted at
`passageway comprising:
`room temperature through a small catheter and on exit
`an elongate member having ?rst and second open
`therefrom, thermally caused by body temperature to
`ends and a lumen therethrough, said member ex
`assume a desired initially imparted coil or other con?g
`pandable from a ?rst position wherein said member
`uration with the body.
`is sized for transluminal placement within said
`In addition to producing expansion of prosthesis 10
`body passageway to a second position wherein said
`by injection of a hot saline solution or exposure to nor
`member is larger than said body passageway, said
`mal body temperature of a prosthesis having a transition
`member expanding in response to an increase in
`temperature equal to normal body temperature, expan
`temperature such that after placement within said
`sion thereof may also be produced by induction or mi
`body passageway and upon heating of said member
`crowave warming of the prosthesis through the skin, or
`to a temperature equal to or in excess of normal
`by passing a current through the graft prosthesis from
`body temperature said member expands radially so
`electrodes located on the guide catheter or by a separate
`as to become ?rmly anchored in said body passage
`heating device temporarily positioned through a cathe
`way, expansion of said member also causing expan
`ter.
`sion of the diameter of said lumen.
`Further, while prosthesis 10 has been described for
`8. The apparatus of claim 7, wherein said member is
`use in expanding partially occluded segments of a blood
`formed of a shape memory Nitinol alloy.
`-
`vessel passageway, it is to be understood that with only
`9. The apparatus of claim 8, wherein the transitio
`minor modi?cations thereto prosthesis 10 may be used
`temperature of said Nitinol alloy is in a range between
`for many purposes such as the following: (1) stent sup
`115-125 degrees Fahrenheit.
`portive graft placement within blocked arteries opened
`10. A method for expanding a narrowed segment of a
`by transluminal catheter recanalization but likely to
`body blood vessel passageway comprising the steps of:
`collapse in the absence of an internal support; (2) similar
`(l) inserting a vascular prosthesis within a narrowed
`use following catheter passage through mediastinal and
`segment of a blood vessel passageway; and
`other veins occluded by inoperable cancers; (3) rein
`(2) expanding said prosthesis within said narrowed
`forcement of catheter created intrahepatic communica
`segment of said blood vessel passageway by in
`tions between portal and hepatic veins in patients suffer
`creasing the temperature of said prosthesis to a
`ing from portal hypertension; (4) coil spring stenting of
`level which is in a range at or above normal body
`narrowing of the esophagas, the intestine, the ureters,
`temperature thereby expanding the lumen of said
`and the urethra; (5) stent-reinforcement of reopened and
`prosthesis and also the blood vessel passageway
`previously obstructed bile ducts; and (6) biliary cirrho
`along said narrowed segment.
`sis.
`11. The method of claim 10 wherein step (1) is accom
`While the invention has been illustrated and de
`plished by transluminally inserting said vascular pros
`scribed in detail in the drawings and foregoing descrip
`thesis by catherization of said body blood vessel.
`tion, the same is to be considered as illustrative and not
`12. The method of claim 11 wherein step (2) is accom
`restrictive in character, it being understood that only
`plished by injecting a hot fluid within said body blood
`the preferred embodiment has been shown and de
`vessel so as to bathe said prosthesis and thereby trigger
`scribed and that all changes and modi?cations that
`its expansion.
`come within the spirit of the invention are desired to be
`13. The method of claim 12 wherein injection of said
`protected.
`hot fluid also expands a catheter balloon thereby limit
`What is claimed is:
`ing ?uid flow through said body blood vessel and de
`1. A transluminally-placed endovascular graft pros
`creasing thermodilution of said hot ?uid within said
`thesis, comprising:
`vessel.
`a tubular shaped member having ?rst and second
`14. A method for implanting a prosthesis within a
`open ends and lumen therethrough, said member
`body passageway comprising the steps of:
`sized for transluminal placement within a body
`(l) inserting said prosthesis within said body passage
`blood vessel, said member made of a shape memory
`way by catherization of said passageway; and
`material having a transition temperature in a range
`(2) expanding said prosthesis at a desired location '
`at or above normal body temperature such that
`within said body passageway by increasing the
`after placement within said body blood vessel and
`temperature of said prosthesis to a level which is in
`upon heating of said member to a temperature
`65
`a range at or above normal body temperature
`higher than normal body temperature said member
`thereby expanding the lumen of said prosthesis
`expands radially so as to become ?rmly anchored
`within said body passageway.
`to the inside wall of said body blood vessel, expan
`
`30
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`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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`Edwards Exhibit 1009, p. 6
`
`

`

`UNITED STATES PATENT AND‘ TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`4,503,569
`; March 12, 1985
`
`PATENTNO.
`DATED
`
`|NVENTOR(S) :
`
`Charles T. Dotter
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby
`corrected as shown below:
`
`Column 2, line 16, change "allow" to -— alloy -—-.
`
`‘
`[SEAL]
`
`Arrest:
`
`Signed and Scaled this
`Twenty~sevenlh_ D3)’ of August 1985
`-
`
`Attesting Officer
`
`Acting Commissioner 0 f Parents and Trademarks
`
`DONALD J. QUIGG
`
`Edwards Exhibit 1009, p. 7
`
`