throbber
United States Patent 1191 "
`Kornberg
`
`[11] Patent Number:
`[45] Date of Patent:
`
`,
`
`4,562,596
`l Jan. 7, 1986
`
`[54] AORTIC GRAFT, DEVICE AND METHOD
`FOR PERFORMING AN INTRALUMINAL_
`ABDOMINAL AORTIC ANEURYSM REPAIR
`[76] Inventor:
`Elliot Kornberg, Suite 416, Cape
`Royal Bldg,’ 1980 N,v Atlantic Ave,’
`Cocoa Beach’ Fla‘ 32931
`
`1
`
`[21] Appl. No.: 603,800
`_
`[22] Flled:
`Apr‘ 25’ 1984
`[51] Int. (31.4 ........................ .. A61F 1/24; A61F 1/22;
`A61B 17/00
`[52] U.S. Cl. ................................ .,. 623/1; l281/2I’:;;l32R5;
`[58] Field of Search .................. .. 3/14, 1; 128/334 R,
`123/334 (3, 343, 1 R, 325
`,
`References Cited
`115- PATENT DOCUMENTS’
`2,845,959 3/1956 Sidebotham ...................... .. 139/387
`2,978,787 4/1961 Liebig .................... .. 28/73
`3,874,388 4/1975 King et a].
`128/334 R
`33821845 5/1975 Bucalo ------------ -'
`128/334 R X
`gfizliulov et a1‘
`""" "
`g
`4:140:126 2/1979 "Choudhury
`'
`_____ __ 128/325
`4,167,045 9/1979 Sawyer
`3/l.4
`4,190,909 3/1980 Ablaza .......................... ..,= ...... .. 3/l.4
`
`[56]
`
`4,229,838 10/1980 Mano , . . . . . . . . . . . .
`
`. . . . . .. 3/l.4
`
`4,202,349 5/1980 Jones ................................. .. 128/689
`4,204,526 5/1980 Samuels et a1.
`.. 128/1 R
`4,286,341 9/1981 Greer et a1.
`3/ 1.4
`4,309,776 1/1982 Berguer . . . . . .
`3/1
`4,313,231 2/1982 Koyamada
`3/l.4 ‘
`4,355,426 10/1982 MacGregor
`..... .. 3/1.4
`4,425,908 l/l934 Simon .............................. .., 128/1 R
`,
`Primary Examiner—Richard J. Apley
`Assistant Examiner—Alan W. Cannon
`Attorney, Agent, or Firm—B9v9ridge, DeGrandi &
`We?acher.
`,
`-
`[57]
`ABSTRACT
`An aortic graft that is speci?cally constructed for intra
`luminal insertion and comprising a ?exible hollow, tu
`bular material, having a’ generally cylindrical shape
`with an upper end and lower end and having a minor
`and major axis, and having'disposed along its major axis
`a plurality of Parallel Struts, the Struts having angled
`hooks with barbs at their upper ends, the upper ends of
`the struts extending beyond the upper end of the tubular
`material, thus allowing-the graft to be securely attached
`to the inside of the aorta above the aneurysm. A tubular
`device for inserting the graft is also disclosed.
`'
`
`. .
`
`9 Claims, 10 Drawing Figures ’
`
`W.L. Gore & Associates, Inc.
`Exhibit 1022-1
`
`

`

`U.S. Patent Jan. 7,1986
`
`Sheetl of2
`
`4,562,596
`
`PM
`
`g
`
`i
`
`j
`
`“i E
`
`, i_ 4 U
`
`H65
`
`W.L. Gore & Associates, Inc.
`Exhibit 1022-2
`
`

`

`US. Paténf Jan. 7,1986
`
`Sheet20f2
`
`4,562,596
`
`W.L. Gore & Associates, Inc.
`Exhibit 1022-3
`
`

`

`1
`
`AORTIC GRAFI', DEVICE AND METHOD FOR
`PERFORMING AN INTRALUMINAL
`ABDOMINAL AORTIC ANEURYSM REPAIR
`
`4,562,596
`2
`down is a creation of a small, incised opening, especially
`over a vein or other critical vessel.
`A further feature of the invention resides in a method
`employing a tubular device having mounted therein a
`new vascular graft and comprising forming an opening
`in a femoral artery, inserting a vascular graft into the
`artery and moving the graft in an upwardly direction
`into the aorta without the need for general anesthetic.
`A still further feature of the invention resides in a
`device made of a plurality of tubes having a generally
`cylindrical con?guration and having mounted therein
`the new vascular graft structure, which device is de
`signed for easy operation in positioning the graft in the
`desired location in the damaged artery.
`Additionally, a feature of the invention resides in a
`tubular graft material having a plurality of struts or
`stays equipped with hooks for rapid and secure attach
`ment within the desired location of the damaged artery.
`The nature and characteristic features of the present
`invention will be better understood through the follow
`ing detailed description and accompanying drawings
`wherein:
`FIG. 1 shows an aortic bifurcation graft used in ac
`cordance with the invention. The graft is equipped with
`a circumferential row of hooks and a plurality of longi
`tudinal struts.
`FIG. 2 shows an enlarged view of the upper end of a
`strut and hook.
`FIG. 3 shows the tubular device of the invention used
`to insert a graft.
`FIG. 4 shows the tubular device of the invention
`containing the graft encased within it and ready for
`intraluminal insertion.
`FIG. 5 shows a portion of the means for holding the
`graft inside the tubular device.
`FIG. 6 shows the device with the encased graft being
`inserted inside the aorta through a femoral artery cut
`down.
`FIG. 7 shows the strut supported graft being posi
`tioned into the other illiac artery and above the aneu
`rysm.
`FIG. 8 shows the deployment and attachment of the
`graft proximally to the aorta above the aneurysm.
`FIG. 9 shows the graft in place and excluding the
`aneurysm from the circulation.
`FIG. 10 is a cross sectional view through the proxi
`mal end of the graft and aorta showing the circumferen
`tial attachment of the graft to the aorta.
`The invention will now be described in further detail
`with reference to the drawings.
`In FIG. 1, the bifurcated graft 10 with its supporting
`struts 12 is illustrated. Since the purpose of this inven
`tion is to permanently place the vascular graft in
`traluminally to exclude the aneurysm from the blood
`?ow, then the graft must have support along its length,
`so that the blood flow does not dislodge it, over the
`lifetime of the patient. The ?exible conduit 10 which
`constitutes the bifurcated graft of this invention is suffi
`ciently flexible to be capable of conforming to the inte
`rior contour of the wall portion of the artery into which
`it is inserted. The graft is a generally cylindrical, hol
`low, bifurcated sleeve with longitudinal supporting and
`reinforcing members called struts 12 running along the
`major axis of the cylindrical sleeve. The struts assure
`proper orientation of the graft within the artery. The
`bifurcated graft 10 has two legs, with one leg thereof
`10A generally being longer than the other 10B.
`
`The invention concerns an aortic graft, a device and
`method for the intraluminal repair and treatment of
`abdominal aortic aneurysms.
`An abdominal aortic aneurysm is a sac caused by an
`abnormal dilation of the wall of the major artery of the
`body as it passes through the abdomen. The abdomen is
`that portion of the body which lies between the thorax
`and the pelvis. It contains a cavity, known as the ab
`dominal cavity, separated by the diaphragm from the
`thoracic cavity and lined with a serous membrane, the
`peritoneum. The aorta is the main trunk from which the
`systemic arterial system proceeds. It arises from the left
`ventricle of the heart, passes upward, bends over and
`passes down through the thorax and through the abdo
`men to about the level of the fourth lumbar vertebra,
`where it divides into the two common illiac arteries.
`The aneurysm usually arises in the infrarenal portion
`of the arterioscleroticly diseased aorta, i.e. below the
`kidneys. When left untreated, the aneursym will eventu
`ally cause rupture of the sac with ensuing fatal hemor
`rhaging in a very short time. The high mortality associ
`ated with the rupture has lead to the present state of the
`art and the transabdominal surgical repair of abdominal
`aortic aneursyms. Surgery involving the abdominal
`wall, however, is a major undertaking with associated
`high risk. There is considerable mortality and morbidity
`associated with this magnitude of surgical intervention
`which in essence involves replacing the diseased and
`aneurysmal segment of blood vessel with a prosthetic
`device which is a synthetic tube, usually fabricated of
`either Dacron (a polyester), polytetra?uoroethylene, or
`other suitable material.
`If the aneurysmal segment of the aorta can be func
`tionally excluded from the pressures of the blood ?ow
`then the condition can be treated even without excising
`the diseased segment of aorta.
`It is therefore the object of this invention to provide
`a method to exclude the aneurysmal segment of abdomi
`nal aorta from the circulation without the need for
`major abdominal surgery.
`A further object of this invention is to reduce the
`mortality and morbidity associated with an extensive
`abdominal operation and the need for a general anes
`thetic in patients who usually have other associated
`diseases.
`A still further object of this invention is to allow for
`the emergency stabilization of patients with ruptured
`abdominal aortic aneurysms.
`A still further object of the invention is to provide a
`method for treatment of abdominal aortic aneurysms
`without the need for surgical intervention through the
`abdominal wall.
`A further object of the invention is to provide a de
`vice for repair of abdominal aortic aneurysms which
`will reduce the mortality and morbidity associated with
`major abdominal surgery.
`In achieving these and other objects, one feature of
`the invention resides in a method whereby a vascular
`graft of a new con?guration is inserted into the inside of
`65
`the aorta through a cutdown in the femoral artery. In
`this way, the aneurysmal segment of the abdominal
`aorta is excluded from the circulation system. A cut
`
`5
`
`45
`
`W.L. Gore & Associates, Inc.
`Exhibit 1022-4
`
`

`

`‘4,562,596
`
`5
`
`25
`
`3
`A variety of different con?gurations may be used so
`that the number of circumferential located strengthen
`ing struts or ribs 12 attached or formed in the wall of the
`graft may vary from a minimum of four up to twelve or
`more, preferably eight. The upper limit on the number
`of struts is not critical provided that no more are used
`than is necessary. Of course with more struts, the graft
`becomes increasingly more rigid.
`The struts or strays may be formed of any suitable
`material, surgical steel being an example of one such
`substance. Being preferably formed of steel, the struts
`permit the graft to be readily observed by X-ray visual
`ization- techniques during deployment in the artery. The
`degree of ?exibility of the struts can vary provided that
`the vascular graft is suf?ciently rigid to perform in
`accordance with the method of the invention.
`The struts can run the length of each leg or only part
`of the entire length of each leg of the graft. Typically,
`the struts will run essentially the entire length of each,
`leg or a majority of the distance along each leg. Gener
`20
`ally, each graft will have three different size of struts;
`namely, a long strut for the long leg 10A, a shorter strut
`for the shorter leg 10B, and an even shorter strut 13
`which will extend from the circular opening 16 at the
`top of the graft to the point of bifurcation.
`The-material of the graft may typically be fabricated
`from ?exible natural or synthetic polymeric substances
`such as polyester fabric (DACRON), polytetra?uoro
`ethylene and the like. Other substances such as Mylar,
`rayon, cellulose acetate, cellulose butyate may also be
`used. These substances may be specially woven and/ or
`treated textile fabric material inert to body ?uids and
`compatible therewith. Many such biologically compati
`ble materials are known in the art and may be used for
`purposes of this invention. Typically, these materials
`are very thin, on the order of 0.5 mm.
`Generally, the graft is prepared and packaged under
`aseptic conditions to avoid contamination. It is further
`contemplated that the graft may be treated with non
`wettable substance such as liquid silicone or wax. It may
`also be cleaned with an antibiotic prior to use. Further,
`it may be treated with an anticoagulant. All such tech
`niques are known in the art and may be used according
`to the present invention as desired or necessary.
`The length of each leg of the graft can be determined
`by experience and will vary somewhat depending on
`the patient. The graft is characterized by 3 important
`dimensions; namely, the length of the single tube of the
`graft before the point or bifurcation, the length of the
`short leg 10B and the length of the long leg 10A. Gener
`ally, the upper tubular section will range from 5 to 10
`cm, the short leg 10 will range from 5 to 15 cm and the
`longer leg will range from 15 to 20 cm. The lengths of
`the long and short leg can be tailored in the operating
`room to fit the intended patient. It is for this reason that
`the struts may: not go to the complete end of each leg;
`that is, in order to enable the surgeon to cut off a short
`piece of the end of the leg to tailor it to the speci?c
`patient.
`The proximal attachment of the graft 10 to the inside
`wall of the aorta is accomplished by the hooks 14 which
`are located at. the upper end of each strut 12. The row
`of hooks 14 forms a ring around the outer circumfer
`ence of graft 10' and are oriented downwardly at an
`angle of about 10°—45° C. with respect to the vertical.
`Each hook 14'has a barb 15 located at the lower end of
`the hook so‘ as to inhibit upward movement which
`might tend to dislodge the graft after it is positioned and
`
`45
`
`60
`
`65
`
`4
`attached to the aorta wall. While FIG. 1 shows a hook
`14 at the upper end of each strut 12, it is to be under
`stood that the hooks could be fewer in number than the
`number of struts; e.g. the hooks could be attached to
`every other strut.
`_
`A ?exible ring 16 located at the upper end of the graft
`10 functions to exclude the multiple punctures in the
`aorta, where the hooks 14 pierce the blood vessel, from
`the blood flow after the graft is set in position. The ring
`16 may be fabricated of flexible, resilient plastic or rub
`ber which is in the compressed, or partially open state
`prior to positioning in the damaged artery. Once in
`place, the ring will spring open and snug up against the
`walls of the artery covering the punctures in the arterial
`wall made by the hooks 14. It is contemplated that a
`graft could also be made without the resilient ring 16.
`The graft has struts 12 that run for essentially the
`length of the strut along its longest leg 10A as well as
`midline struts 13 which extend only to the bifurcation of
`the graft 10. This gives added longitudinal support to
`the graft when it is in place. It also gives more flexibility
`to the other or shorter graft limb 10B, so that it can be
`positioned more easily into theother side. The struts
`may be formed of any biologically acceptable material
`such as surgical steel or even plastic of suf?cient rigidity
`and preferably radiologically opaque to permit visual
`ization during the positioning of the graft in the patient.
`In FIG. 2, the upper end of the strut 12 is shown with
`the hook 14 coming off at about a 30 degree angle. At
`the uppermost end of strut 12, there is formed an eyelet
`or opening to permit temporary engagement with other,
`holding means to be described below. Preferably, the .
`barb 15 on the lower end of hook 14 is oriented parallel.
`to the strut 12. This allows a ?rm anchoring into the
`tissues and also lessens the risk of damaging surrounding
`organs. Although the preferred embodiment of’ the
`invention includes the formation of the hook 14 as
`shown in FIG. 2, it is contemplated that other fastening
`means may be suitably used for this purpose such as
`clips, needles or any permanent suture material. The.
`barb 15 at the end of the hook 14 is only a fraction of the
`length of the hook, typically 2 to 8 mm. Because the
`barb 15 is preferably parallel to the strut, it lies in a safe
`manner parallel to any other organs so as to prevent
`damage thereto and to further limit cutting back
`through aorta. The hook 14' and barb 15 may be formed
`of the same material as the strut 12.
`In FIG. 3, the tubular positioning device 32 of the
`invention is shown without the graft in place. The de
`vice comprises a plurality of concentrically arranged
`sliding tubes including an outer casing or tube 38 ?tted
`with a separable bullet shaped upper top 30 and which
`together form a cylindrical hollow outer housing. Outer
`casing 38 is removed by slipping or pulling it off prior to
`deployment. Contained within the outer hollow tubular
`housing 38 is hollow, generally cylindrical tube 36, the
`major axis of which coincides with the major axis of the
`housing 38. At the upper end of tube 36 are fastened a
`plurality of arms 20. Only two of such arms 20 are
`shown in FIG. 3 but it is to be understood that the
`number of arms 20 coincide with the number of hooks
`14 eyelets. The arms 20 are shaped so as to readily
`engage with the eyelet formed at the top end of strut 12.
`A second hollow, generally cylindrical tube 34 is in
`sliding engagement over the ?rst, or inner, tube 36. A
`fenestrated collar or ring 24 is attached at the upper end
`of the outer tube 34. Tube 34 in the position shown in
`FIG.-3 is located. somewhat below the top of inner tube
`
`W.L. Gore & Associates, Inc.
`Exhibit 1022-5
`
`

`

`20
`
`25
`
`30
`
`35
`
`4,562,596
`6
`5
`?ow begins to enter the graft, the shorter leg 10B ?oats
`36. Arms 20 are attached at the upper edge of tube 36
`free in the blood stream and may be directed to the
`and pass downwardly through the fenestrations in ring
`proper position.
`24. The arms ?air gently outwardly towards the interior
`In FIG. 7, the graft 10 is shown being positioned at
`perimeter wall of top 30 and when at rest hang essen
`tially vertically downward. Thus, by moving inner tube
`the neck of the aneurysm 56 below the renal arteries 54
`after the free graft limb 10B has been ?oated into posi
`34 with respect to tube 36 in an upwardly or down
`tion in the right illiac artery 58.
`wardly direction, the arms 20 attached at the top of tube
`In FIG. 8, the capsule 30 has been elevated off of the
`34 are movable therein as limited by the size of the
`upper end of the graft 10 by pushing on small inner tube
`fenestrations and can be opened and closed similar to
`40. The arms 20 of the device have been opened by
`the ribs on an umbrella. All tubular members may be
`formed of ?exible plastic or metal. It is important that
`pushing upwardly on tube 34 and the hooks 14 have
`the material be radioopaque so that the location of the
`been set into the aortic wall by gentle downward trac
`apparatus can be easily seen on visualizing equipment
`tion on the device. The device arms are then collapsed
`employed during deployment of the graft in the patient.
`by pulling downwardly on tube 40 so as to lower cap
`The outer casing 38 ?ts snugly into the under surface
`sule 30 onto the arms 20 and the device is removed
`of a bullet shaped capsule 30 and acts as a protective
`through the inside of the graft by pulling it out. The size
`sleeve for the graft prior to use. Prior to depolyment of
`of the capsule 30 and the graft limb are such that the
`the graft, the casing 38 may be slipped off and disposed
`graft limb is snugged into place in the illiac artery as the
`of. This allows easy passage of the device through the
`device is withdrawn out of that artery.
`artery. The capsule 30 is secured by a centrally located
`In FIG. 9, the graft 10 is shown in place. The aneu
`hollow tube 40 inside tube 36 which passes up through
`rysm 52 is excluded from the circulation. The small
`the casing 38 from its lower end, through which angiog
`cutdown opening in the femoral artery 50 has been
`raphy can also be performed. At the lower end of the
`repaired by standard vascular surgical technique. The
`device there are three lock nuts 41 or other suitable
`downward ?ow of blood holds the distal graft limbs
`fastening means. These serve the dual purpose of secur
`10A and 10B in place so that no mechanical attachment
`ing the sliding tubes 36 and 34 in place and providing a
`is necessary distally. There is no danger of collapse of
`blood tight seal as the procedure is performed. A con
`the distal end of the tubes 10A and 10B even if struts 12
`nector 42 for angiography is also provided but is an
`do not go to the entire length of the limbs. The ?ow
`optional feature of the device. A syringe (not shown)
`mechanism of the blood keeps the graft open. Ring 16 is
`may be attached to 42 for this purpose. The fastening
`shown in its sprung open position ?tting snugly against
`means 41 can be the same or different and are in stag
`the arterial wall just above the location of the aneurysm.
`gered arrangement as shown in order to prevent im
`The material of the ring 16 can be any biologically
`pingement on each other. All the tubes 40, 36 and 34 are
`acceptable substance such as a resilient silicone rubber.
`nested together as shown in the drawings and are mov
`Functioning to keep the graft fully expanded, ring 16
`able relative to each other by pulling or pushing motion.
`?ts up against the arterial wall 56 so the blood does not
`The diameter and overall dimensions of device 32 is not
`run between the graft and the arterial wall. Leakage of
`narrowly critical and may vary depending on the pa
`blood into the area of the aneurysm is thereby mini- ‘
`tient. The upper limit in size is clearly that which will
`mized.
`just fit into the artery and the lower limit will be that
`The proximal attachment of the graft is shown in
`dimension which will enable all components and the
`cross section in FIG. 10. The aortic wall at the neck of
`graft to be contained therein.
`the aneurysm 56 is pierced by the multiple radially
`In FIG. 4, the device 32 is shown with the graft 10
`placed hooks 14. These puncture wounds are then ex
`loaded inside and ready for insertion into the aorta. The
`cluded from the blood ?ow by the snug ?t provided by
`graft is inserted from below at the lower end of casing
`the ?exible ring 16 at the top of the graft. This then
`38 and is gently pushed up until the lower end of arms
`45
`accomplishes the goal of excluding the abdominal aortic
`20 which have a hook or other single fastening means
`aneurysm from the circulation.
`'
`formed therein engage with the upper end of the strut
`Depending on the site of rupture, this method and
`12. The upper end of strut 12 can have an eyelet, hook,
`device would be used instead of or in preparation for
`loop, ring or any other suitable fastening means formed
`the standard abdominal approach. This would greatly
`integral therewith for rapid and simple disengagable
`reduce the considerable mortality and morbidity associ
`connection with arms 20. The graft 10 would be loaded
`ated presently with abdominal aortic aneurysmectomy
`at the place of manufacture and the entire device suit
`for ruptured aneurysms.
`ably packaged as, for example, in a “blister” pack and
`It should be noted that there can be :variationsof this
`would be marketed as a disposable item. The protective
`device and grafting procedure, such as using a straight
`casing 38 keeps the preloaded graft 10 neatly folded up
`tube graft rather than the bifurcation graft, that is illus
`inside and when ready for use is inserted into the cut
`trated, which do not depart from the spirit and scope of
`down and then slipped out when ready for deployment.
`the present invention and are intended to be encom
`FIG. 5 shows in detail how the device arm hook 20
`passed by the claims appended hereto.
`engages with the eyelet hole in the upper end of the
`I claim:
`strut 12.
`1. An aortic graft that is speci?cally constructed for
`In FIG. 6, the graft loaded device 32 shown in the
`intraluminal insertion and comprising a ?exible hollow,
`process of insertion through a cutdown inside the aorta
`tubular material, having a generally cylindrical shape
`60. The usual location of the anuerysm 52 in relation
`with an upper end and lower end and having a minor
`ship to the renal arteries 54 and the neck of the aneu
`and major axis, and having disposed along its major axis
`rysm 56 is shown. The right 58 and left 57 illiac arteries
`a plurality of parallel struts, the struts having angled
`and the femoral 50 artery are also shown. At this stage,
`the short leg 10B is still folded against the longer of the
`hooks with barbs at their upper ends, the upper ends of
`the struts extending beyond the upper end of the tubular
`two legs 10A. At the appropriate point when blood
`
`40
`
`55
`
`65
`
`W.L. Gore & Associates, Inc.
`Exhibit 1022-6
`
`

`

`4,562,596
`8
`7
`6. The aortic graft of claim 1, further comprising
`material, thus allowing the graft to be securely attached
`wherein the angled hooks are in a downward and out
`to the inside of the aorta above the aneurysm.
`ward direction from 10° to 45°.
`2. The aortic graft of claim 1, wherein the material is
`7. The aortic graft of claim 6, further comprising
`a material or synthetic fabric material inert to body
`wherein the barbs on said angled hooks are parallel to
`the struts.
`8. The aortic graft of claim 1 further comprising the
`upper end of said tubular material having a resilient ring
`integral therewith which ring is capable of being com
`pressed to a size smaller than its normal diameter.
`9. The aortic graft of claim 1 further comprising a
`bifurcated structure wherein the ?exible tubular mate
`rial has two legs, one of said legs being shorter than the
`other.
`
`* * * * *
`
`?uids.
`_
`3. The aortic graft of claim 1, further comprising at
`least 4 struts arranged essentially parallel to the major
`axis thereof.
`4. The aortic graft of claim 1 further comprising the
`upper end of said struts having fastening means above
`said angled hooks.
`5. The aortic graft of claim 4, further comprising
`fastening means which are eyelets.
`
`15
`
`25
`
`35
`
`40
`
`45
`
`55
`
`60
`
`65
`
`W.L. Gore & Associates, Inc.
`Exhibit 1022-7
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`PATENTNU. 14,562,596
`Page 1 of 2
`DATED
`3 January 7, 1986
`INVENTURIS) 1 Elliot Kornberg
`
`It is uni?ed that error appears in the above-identified pateht and that said Letters Patent is hereby
`counted as shown below:
`
`Sheet 1 of the drawings, consisting of Figs. 2 and 5, should be deleted
`to be replaced with the sheet of drawings, consisting of Figs. 2 and 5,
`as shown on the attached page.
`
`Sheet 1, FIG. 2 should appear as follows:
`
`Sheet 1, FIG. 5 should appear as follows:
`
`W.L. Gore & Associates, Inc.
`Exhibit 1022-8
`
`

`

`PATENTNO.
`DATED
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`4,562,596
`Page 2 of 2
`January 7, 1986
`Elliot Kornberg
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby
`comcted as sham below:
`
`INVENTONS) :
`
`Column 3, line 19, after "length" add -- or beyond the
`length -—.
`
`Signed and Sealed this
`
`Sixteenth Day of November, 1993
`
`LZMW
`
`BRUCE LEHIVIAN
`
`Arrest.‘
`
`Attesting O?icer
`
`Commissianer 0f Patents and Trademarks
`
`W.L. Gore & Associates, Inc.
`Exhibit 1022-9
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