United States Patent [19]
`Martin
`
`Illlllllllllllllllllllllllll||l|lllll|lll|l||l|ll||llllllllllllllllllllllll
`USOO5575 817A
`[11] Patent Number:
`5,575,817
`[45] Date of Patent:
`Nov. 19, 1996
`
`[54] AORTO FEMORAL BIFURCATION GRAFT
`AND METHOD OF [MPLANTATION
`
`[76] Inventor: Eric c. Martin, 134 Old Post Rd.
`
`4,787,899 11/1988 Lazarus ..................................... .. 623/1
`5,104,399
`4/1992 Lazarus ..... ._
`623/1
`5,316,023
`5/1994 Palmaz e161.
`128/898
`623/1
`5,383,926
`"1995 Locketal
`
`North’ Croton on Hudson,
`
`
`
`Chuter ....................................... .. Primary Examiner—Michael J. Milano
`
`[21] Appl. No.: 293,541
`[22] Filed:
`Aug. 19,1994
`[51] Int. Cl.6 ...................................................... .. A61F 2106
`[52] US. 01. ................................................. .. 623/1; 623/12
`[58] Field of Search .................................. .. 623/1, 11,12;
`606/191, 198
`
`[56]
`
`References Cited
`
`U-S- PATENT DOCUMENTS
`3,657,744 4/1972 Ersek.
`4,140,126
`2/1979 Choudhury.
`4,512,338
`4/1985 Balko et a1. 1
`4,577,631
`3/1986 Krearner 1
`
`Attorney, Agent, or Firm—Fu1bright & Jaworski L.L.P.
`1571
`ABSTRACT
`An apparatus and method for reinforcing a bifurcating blood
`vessel- T he apparatus comprises two sections that form an
`inverted Y-shape graft ProsthesiS when Joined together
`inside the blood vessel. The method comprises inserting the
`two sections into the bifurcating blood vessel by encasing
`the sections in retractable membranes mounted on two
`catheters, inserting the catheters into the blood vessel,
`deploying and attaching the ?rst section to the vessel,
`deploying the second section and joining it to the ?rst
`SW10“
`
`17 Claims, 3 Drawing Sheets
`
`1
`
`l
`I
`
`I02
`1:93
`‘.‘QA
`
`I2
`
`8
`
`\ ~ _ _ _ _ _ _ __ .
`
`7
`
`9
`
`“9103101. r12
`
`W.L. Gore & Associates, Inc.
`Exhibit 1003-1
`
`

`

`5,575,817
`
`e
`
`S771 w
`
`1 0‘
`e 3'6 h 004
`t 33
`xv‘
`
`fF'VQQ 0 3'‘
`
`1...‘
`3.. at
`xv”
`OVA
`
`I.) s!
`0101
`
`‘
`
`US. Patent
`
`V. 0 N
`
`9.,
`1
`
`6 9 9 1
`
`K J
`
`F l G.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1003-2
`
`

`

`US. Patent
`
`Nov. 19, 1996
`
`Sheet 2 of 3
`
`5,575,817
`
`FIG. 3
`
`W.L. Gore & Associates, Inc.
`Exhibit 1003-3
`
`

`

`US. Patent
`
`Nov. 19, 1996
`
`Sheet 3 of 3
`
`5,575,817
`
`FIG. 4
`
`a) [23
`
`301033101031 7
`
`e
`
`5
`
`22/
`
`f2
`
`.1}
`
`\
`
`2|
`
`I
`
`I
`
`24
`
`W.L. Gore & Associates, Inc.
`Exhibit 1003-4
`
`

`

`1
`AORTO FEMORAL BIFURCATION GRAFT
`AND METHOD OF IMPLANTATION
`
`5,575,817
`
`2
`The ?rst stage of the method according to the invention is
`performed from the more favorable iliac system for primary
`access. This is usually the vessel which is the least torturous
`and the least diseased. The ?rst section of the inverted Y
`graft, encased within a retractable membrane, is mounted on
`the head of a catheter. The catheter is introduced into the
`iliac artery through a vascular sheath or surgical cut and is
`advanced into the aorta. Under anglographic and ?uoro
`scopic control, the catheter is positioned immediately below
`the renal arteries. By partially withdrawing the retractable
`membrane, the upper limb of the inverted Y is released. As
`it releases, it expands and fastens to the walls of the aorta by
`barbs, hooks, or some other means. The remaining portion of
`the ?rst section is then released into the aorta and the ?rst
`iliac artery by fully withdrawing the retractable membrane.
`The catheter is then removed.
`The second stage of the method according to the invention
`is performed from the contralateral side of the body. A
`second catheter, having a retractable membrane containing
`the second section of the inverted Y graft, is introduced into
`the iliac artery from the contralateral side of the body and
`advanced into the aorta. Under ?uoroscopic control, the
`catheter is positioned inside the partial lower limb of the
`inverted Y of the deployed ?rst section. By partially with“
`drawing the retractable membrane, the second section of the
`inverted Y is released and expands to form a ?t, which may
`be reinforced with barbs or hooks, with the ?rst section of
`the inverted Y. The inverted Y is thereby completed. By fully
`withdrawing the membrane and catheter, the second lower
`limb is positioned inside the second iliac artery.
`The completion of the two stage procedure results in the
`insertion of the inverted Y graft with the upper limb
`anchored to the aorta above the aneurysm and the lower
`limbs positioned in the corresponding iliac arteries.
`Another object of the present invention is to provide
`support to the inverted Y graft in order to prevent it from
`kinking or twisting once deployed. This is accomplished by
`bonding the graft to the inside of a self-expanding, mesh
`support tailored to the same measurements. The support may
`be a stent or a similar structure. Once the inverted Y graft is
`deployed, the mesh provides the graft with the necessary
`support to prevent it from kinking or twisting.
`Another object of the present invention is to prevent the
`formation of thrombi that may result from the prolonged
`exposure of blood to any metallic surface. This is accom
`plished by covering the mesh support with a suitable non
`metallic material.
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`This invention relates to a graft prosthesis for placement
`within a bifurcating blood vessel, such as the lower abdomi
`nal aorta, without the requirement for open surgery.
`2. Description of the Related Technology
`Blood vessels, particularly the lower abdominal aorta and
`the iliac vessels, are subject to aneurysm formation and
`severe atherosclerotic disease which leads to multiple
`stenoses. Traditionally, two methods have been used to
`repair blood vessels damaged by these af?ictions. Both
`methods involve the use of a graft prosthesis.
`In the majority of instances a hollow bifurcation graft,
`shaped in the form of an inverted Y, is used to bypass the
`diseased portion of the blood vessel. This involves open
`surgery in which the upper limb of the inverted Y is sutured
`to the aorta immediately below the renal arteries, and the
`lower limbs of the inverted Y are sutured to the correspond
`ing iliac arteries. Unfortunately, this method carries a sig
`ni?cant mortality rate due to the poor health of the patient
`and the risks posed by anesthesia.
`In other instances, a hollow tube graft is inserted by
`catheter into the aorta. The tube is positioned within the
`aorta by ?uoroscopic control and is fastened in place at each
`end by hooks or barbed stents that anchor into the walls of
`the aorta. This method, however, is of limited utility, since
`in the majority of cases the blood vessel damage extends to
`the iliac arteries, requiring an inverted Y graft for repair.
`
`10
`
`25
`
`35
`
`SUMMARY OF THE INVENTION
`
`40
`
`45
`
`It is an object of the present invention to provide a novel
`inverted Y graft prosthesis. It is a further object of the
`invention to provide a method for placing said novel
`inverted Y graft prosthesis in a patient without open surgery.
`It is a further object of the invention to provide a method for
`placing said novel inverted Y graft prosthesis by a catheter.
`Thus, the disadvantages in the prior art are overcome.
`According to the invention, an inverted Y graft is provided
`which is comprised of two sections. The ?rst section of the
`inverted Y graft is comprised of the upper limb, the ?rst
`lower limb, and a partial length of the second lower limb of
`the inverted Y. The second section of the inverted Y graft is
`comprised of the remainder of the second lower limb of the
`inverted Y. The inverted Y graft according to the invention
`may be placed in a patient in two consecutive stages, each
`stage requiring the insertion by catheter of a segment of the
`inverted Y graft. Prior to the initiation of the two stages, the
`length and diameter of the neck of the aneurysm, the aortic
`diameter, the length of the aorta from the renal arteries to the
`bifurcation, and the length of the common iliac arteries are
`measured by angiography or some other appropriate imag
`ing study. These measurements are used to determine the
`appropriate dimensions of the inverted Y graft. The ?rst
`stage of the method according to the invention involves the
`insertion and placement within the blood vessel of the ?rst
`section of the graft. The second stage of the method accord
`ing to the invention involves the insertion and attachment of
`the second section of the graft to the ?rst section. Once the
`65
`second section is attached to the ?rst section, the inverted Y
`is complete.
`
`55
`
`BRIEF DESCRIPTION OF THE FIGURES
`
`FIG. 1 shows the preferred embodiment of the inverted Y
`graft prosthesis according to the invention.
`FIG. 2 shows a second embodiment of the short limb of
`the ?rst section of the inverted Y graft prosthesis according
`to the invention.
`FIG. 3 shows a catheter having a retractable membrane
`containing the ?rst section of the inverted Y graft prosthesis
`according to the invention.
`FIG. 4 shows the inverted Y graft prosthesis fully posi
`tioned within the aorta according to the invention.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS OF THE INVENTION
`
`The preferred embodiment of the present invention is
`illustrated in FIG. 1. The object of the invention is realized
`upon the insertion and union of the ?rst section i with the
`
`W.L. Gore & Associates, Inc.
`Exhibit 1003-5
`
`

`

`5,575,817
`
`3
`second section 2 to form an inverted Y-shape graft in the
`bifurcating lumen. The ?rst section 1 comprises a hollow,
`bifurcation graft 3 made of a suitable material. Examples of
`suitable materials include, but are not limited to, thin walled
`dacron or thin walled polytetra?uorethaline (PTFE). The
`?rst lower limb 4 of the inverted Y graft is cut at an
`appropriate length, normally 8—18 cm, as determined by the
`angiography or anatomy of the individual patient. The
`partial length of the second lower limb 5 is approximately
`2-4 cm. The upper limb 6 of the inverted Y graft is
`approximately 15-35 mm in diameter and approximately
`4-8 cm in length. The whole of this ?rst section is bonded
`and attached to the inside of a compressible expanding mesh
`support 7. The support may be a stent or a similar structure.
`The mesh support 7 may be of a medical grade, super alloy,
`stainless steel and may be entirely covered by a non-metallic
`material 8. It extends approximately 1 cm beyond the
`material of the upper limb 6. This extension 9 accommo
`dates some fastener means such as barbs 10 or outward
`facing hooks 11 to fasten it to the inside of the lumen. The
`line of attachment of the section to the support may be
`marked with ?ne platinum wire 12 for heightened ?uoro
`scopic visibility.
`The second section 2 comprises a hollow tube graft which
`may be of the same material as the ?rst section. It is bonded
`to the inside of an expanding mesh support of the same
`dimensions. The length of this section is such that when it
`forms a complete inverted Y with the ?rst section, the
`completed second lower limb is of an appropriate length as
`determined by the angiography of the patient. The upper end
`13 of the second section 2 is slightly larger in diameter than
`the corresponding diameter 14 of the partial length of the
`second lower limb 5 of the ?rst section 1. This allows for a
`friction ?t of the two sections when the second section 2
`expands within the ?rst section 1. Alternatively or in con
`junction with this friction ?t, the upper end 13 may include
`a fastener means such as barbs, outward-facing hooks, or
`some other means of attachment. The upper and lower ends
`of the second section 2 may be traced with platinum wire 12
`in order to enhance their ?uoroscopic visibility.
`An alternative embodiment of the partial length of the
`second lower limb 5 of the ?rst section is illustrated in FIG.
`2. In this embodiment the expanding mesh support 15
`extends past the covering material of the partial length of the
`second lower limb 5 of the ?rst section.
`The mounting of the ?rst section on a catheter is illus
`trated in FIG. 3. The ?rst section 1 is compressed and then
`mounted in such a way that the catheter 16 passes through
`the ?rst lower limb 4 and the upper limb 6 of the ?rst section.
`The ?rst section, including the partial length of the second
`lower limb, is encased and held in its compressed state by a
`retractable membrane 17. The leading edge 18 of the cath
`eter 16 is tapered to such a diameter that it allows a guide
`wire 19 to pass through it. The trailing edge 20 is recessed
`for the section when it is collapsed onto the catheter and
`retained by the retaining membrane. A luer-lok hub is
`located on the trailing edge of the catheter. The mounting of
`the second section 2 of the graft is performed on a catheter
`in a similar fashion.
`The fully inserted and positioned inverted Y graft is
`illustrated in FIG. 4. To achieve this state, the most favorable
`iliac system 21 is chosen for primary access. This is usually
`the vessel which is least torturous and the least diseased.
`Primary access is accomplished through a surgical cut or
`through a vascular sheath. A second smaller sheath may be
`introduced percutaneously through the contralateral side
`into the femoral artery and a 5 French catheter may be
`
`4
`introduced through the sheath and positioned above the renal
`arteries for anglographic control of the procedure. Referring
`to both FIG. 3 and FIG. 4, a guide wire 19 is introduced
`through the primary access site and advanced into the aorta
`22. Under angiographic and ?uoroscopic control, the cath
`eter on which the ?rst section is mounted is introduced into
`the aorta 22 and positioned immediately below the renal
`arteries 23. The upper limb 6 of the ?rst section of the
`inverted Y is deployed by partially withdrawing the retain
`ing membrane 17 that retains the compressed ?rst section.
`As it deploys, the upper limb expands and fastens to the wall
`of the aorta under the force of the expandable mesh 7. The
`fastening means may be barbs, hooks, or some other means.
`The ?rst section of the graft 1 is then fully deployed as the
`retaining membrane 17 is fully withdrawn. The catheter is
`removed through the iliac artery 21. The ?rst lower limb 4
`of the inverted Y is thus positioned in the iliac artery. The
`second section 2 is similarly introduced through the con
`tralateral iliac artery 24. Under ?uoroscopic and anglo
`graphic control, the second section catheter is positioned so
`that its upper end 13 is inside the partial length of the second
`lower limb 5 of the ?rst section 1. The retaining membrane
`is then partially withdrawn and the upper end 13 of the
`second section is deployed. As it deploys, the second section
`expands under the force of the expandable mesh and fastens
`to the inside of the ?rst section. The fastening means may be
`barbs, hooks, or some other means.
`The second section 2 of the graft is then fully deployed as
`the retaining membrane is fully withdrawn. The catheter is
`then removed through the iliac artery 24. The second lower
`limb of the inverted Y is thus positioned in the iliac artery
`24, and the inverted Y graft is completed.
`I claim:
`1. An apparatus for reinforcing a bifurcated lumen com
`prising:
`a ?rst section, con?gured to be positioned within the
`lumen, comprising:
`an upper limb, con?gured to ?t within the lumen
`upstream of the bifurcation;
`a ?rst lower limb, con?gured to extend into a ?rst leg
`of said bifurcation when said ?rst section is posi
`tioned in the lumen, and
`a second lower limb, shorter than said ?rst lower limb,
`and con?gured so that when said ?rst section is
`positioned in the lumen, said second lower limb does
`not extend into a second leg of said bifurcation.
`2. The apparatus of claim 1, further comprising a second
`section con?gured to be positioned separately within the
`lumen and joined to said second lower limb of the ?rst
`section, effectively extending said second lower limb into
`said second leg of said bifurcation.
`3. The apparatus of claim 2, wherein the ?rst section and
`the second section form an inverted Y-shape when joined.
`4. The apparatus of claim 3, wherein the ?rst and second
`sections each comprise a graft attached to a support.
`5. The apparatus of claim 4, wherein the support com
`prises a compressible and expandable mesh.
`6. The apparatus of claim 4, further comprising a non
`metallic material covering the support.
`7. The apparatus of claim 4, wherein the graft is made of
`a material selected from the group consisting of dacron and
`PTFE.
`8. The apparatus of claim 4, wherein the support com
`prises a metallic mesh.
`9. The apparatus of claim 4, further comprising a platinum
`wire situated at a line of attachment between the graft and
`the support.
`
`10
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`65
`
`W.L. Gore & Associates, Inc.
`Exhibit 1003-6
`
`

`

`5,575,817
`
`5
`10. The apparatus of claim 4, wherein the support extends
`beyond the graft.
`11. The apparatus of claim 4, further comprising a fastener
`attached to the support.
`12. The apparatus of claim 11, wherein the fastener is
`selected from the group consisting of barbs and hooks.
`13. The apparatus of claim 3, wherein the second section
`is a tube graft.
`14. The apparatus of claim 3, further comprising a fas- 10
`tener on one of the sections.
`
`6
`15. The apparatus of claim 14, wherein the fastener is
`selected from the group consisting of barbs and hooks.
`16. The apparatus of claim 3, wherein the lengths of the
`lower limbs of the inverted Y-shape are 8-18 cm, and the
`length of the upper limb of the inverted Y-shape is 4-8 cm.
`17. The apparatus of claim 3, wherein the diameters of the
`lower limbs of the inverted Y~shape are 8-12 mm, and the
`diameter of the upper limb of the inverted Y-shape is 15-35
`mm.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1003-7
`
`

`

`Adverse Decision In Interference ‘
`Patent No. 5,575,817. Eric C. Martin, AORTO FEMORAL BIFURCATION GRAFT AND METHOD OF
`IMPLANTATION, Interference No. 104,192, ?nal judgment adverse to the patents: rendered July 27, 2001,
`as to claims 2-17.
`
`(O?‘icial Gazette October 30, 2001)
`
`W.L. Gore & Associates, Inc.
`Exhibit 1003-8
`
`