Acta Radiologica
`
`ISSN: 0001-6926 (Print) (Online) Journal homepage: http://www.tandfonline.com/loi/iaro20
`
`Catheter Replacement of the Needle in
`Percutaneous Arteriography: A new technique
`
`Sven Ivar Seldinger
`
`To cite this article: Sven Ivar Seldinger (1953) Catheter Replacement of the Needle in
`Percutaneous Arteriography: A new technique, Acta Radiologica, 39:5, 368-376
`
`To link to this article: http://dx.doi.org/10.3109/00016925309136722
`
`Published online: 14 Dec 2010.
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`Date: 09 February 2016, At: 09:29
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`ENDOHEART AG, EX. 2001 Page 1
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530
`
`

`
`FROM THE KOENTBEN DIAQNOSTIC DEPARTMENT (DIRECTOR: PROFESSOR KNUT LIKDBLOM),
`KAROLINSKA SJUKIiUSET, STOCKHOLM, SWEDEN
`.~
`
`CA'l'HE'l'ER IZEI'LACEMENT OF THE NEEDLE 1N
`PERCUTANEOUS AltTERlOGItAPHY
`A new technique
`by
`S v e n I v a r S e l d i n g e r
`
`The catheter method of angiography has become more popular in
`the past few years, as it provides the following advantages over the
`method of injecting the contrast medium by means of a simple needle:
`1) The contrast medium may be injected into a vessel at any level
`desired.
`2) Risk of extravascular injection of the contrast medium is mini-
`mised.
`3) The patient may be placed in any position required.
`4) The catheter may be left in situ without risk while the films are
`being developed, thus facilitating re-examination if necessary.
`Until recently, however, the use of the catheter method was restricted
`because of the lack of a suitable flexible thin-walled catheter which
`could be used percutaneously. FARINAS, in 1941, described a method in
`which a urethral catheter was passed up into the aorta through a trocar
`inserted in the exposed femoral artery. In 1947, RADNER catheterized
`the exposed and ligated radial artery and performed vertebral angio-
`graphy and later thoracic aortography. Since then, many authors have
`catheterized arteries for various purposes, by surgical exposure followed
`by ligature or resuturing of the artery. In 1949, JONSSON performed
`thoracic aortography after puncture of the common carotid artery by
`means of a blunt cannula provided with an inner sharp needle. The
`cannula, guided by a silver thread, was then directed downwards. Later
`Ihiefly presented at the Congress of the Northern Association of Medical Radiol-
`ogy, Helsinki, June, 1952; submitted for publication, October 28, 1952.
`
`~~
`
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`ENDOHEART AG, EX. 2001 Page 2
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530
`
`

`
`369
`
`I
`I
`
`CATHETER REPLACEMENT OF THE NEEDLE 1N PERCCTANEOUS ARTERIOGRAPHY
`the procedure was abandoned, partly because
`it was considered that the cannula might in-
`jure the aortic wall. This percutaneous method
`might have proved more useful if a technique
`for using a flexible catheter of adequate lumen
`had been available a t the time.
`The artery exposure technique of catheter-
`ization is time-consuming, troublesome and
`may present certain risks. The thin-walled poly-
`ethylene tube, however, makes percutaneous
`catheterization possible, as reported by PEIRCE
`in 1951, who passed in the tubing through a
`large bore needle. This method was suitable
`for aortography via the femoral artery. In the
`same year, DONALD, KESMODEL, ROLLINS and
`PADDISON, employing a similar technique, cath-
`eterized the common carotid artery in cere-
`bral angiography . The method necessitates the
`use of a large bore needle which may make
`puncture difficult and limits its use to com-
`paratively large arteries, hence PEIRCE'S at-
`tempts to catheterize the brachial artery were
`disappointing. There is also extra damage to
`the artery and, as the hole in the artery is
`larger than the catheter, haemorrhage after
`removal of the needle may be troublesome. To
`prevent bleeding, the needle may be kept in
`situ during the investigation; this, however, in-
`creases the risk of injury to the patient during
`movement.
`There is a simple method, however, of using
`a catheter the same size as the needle, and
`which has been used at Karolinska Sjukhuset
`since April 1952. The main principle consists
`in the catheter being introduced o'n a flexible
`leader through the puncture hole after withdrawal of the puncture
`needle. The details are as follows:
`Epuipnaent. (Supplied by A. B. Stille- Werner, Stockholm.)
`I ) A puncture needle with stilette.
`2) A flexible rounded-end metal leader with increased flexibility
`of its distal 3 cm.
`3) A polyethylene tube, of the same diameter as the needle, with
`an adapter for the attachment of a syringe.
`26 -530088. Actcc Rncliologiccc. 1'01. 39.
`
`Fig. 1. The equipment. The
`stilette is removed and the
`leader inserted through the
`needle (left) and the catheter
`(right).
`
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`ENDOHEART AG, EX. 2001 Page 3
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530
`
`

`
`370
`
`SVEN IVAR SELDINGEH
`
`Q
`
`C
`
`d
`
`e
`f
`Pig. 2. Diagrani of the technique used. a) The artery punctured. The needle pushed
`upwards. b) The leader inserted. c) The needle withdrawn and the artery compressed,
`d) The catheter threaded on to the leader. e) The catheter inserted into the artery.
`f ) The leader withdrawn.
`
`The leader should have a diameter slightly less than the bore of
`the needle and the catheter, so that it is capable of passing through
`both, and should be at least 8-9
`ern longer than the latter; on the other
`hand it should just fit the lumen of the catheter (Fig. 1). The tip of the
`catheter may be cut before use as shown in Fig. 2.
`
`Technique (see Pig. 2).
`a) After local anaesthesia, the artery is punctured percutaneously
`at a relatively small angle.
`After puncture it is best to rotate the needle 180" and push it a little
`into the artery using the bleeding as a guide to ensure that the needle
`remains in the artery. Puncture of arteries smaller than the femoral
`artery is facilitated by using an inner needle as a guide over which the
`outer needle is directed into the artery.
`b) The supple tip of the leader is inserted a very short distance
`into the lumen of the artery through the needle.
`c) The leader is held in place and the needle removed.
`
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`ENDOHEART AG, EX. 2001 Page 4
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530
`
`

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`CATIIETER REI’IIACEMII,ST OF THE NEEDLE IN PERCUTAhEOUP dn’IEBI@GI{AI’IIP
`
`371
`
`Pig. 3. Hypoplastic lowrr pole of the right kidney. I3lood supply from two branchesIof
`A sinall alwrarrt nrtrry. Catheter inscrtetl through the right femoral artery with tip 2 cm
`below the rerial arteries.
`
`At this nioineiit bleeding should be controlled by pressure on the
`mtery proximal to the puncture site, because the diameter of the leader
`is srnaller than the hole in the artery.
`d) The catheter is threaded on to the leader; when the tip reaches
`the skin the free end of the leader must protrude from the catheter.
`e) The catheter and leader are gripped near the skin through which
`they are inserted. The catheter enters the artery easily as an opening
`has already been made by the needle. The catheter and leader are pushed
`just far enough to ensure that the tip of the former is in the lumen of
`the vessel.
`f) The leader is removed and the catheter directed to the leveI
`required, after good arterial bleeding through the catheter has been
`obtained. The unsupported catheter is usually pushed up the vessel
`without difficulty, but occasionally the leader must be re-introduced
`into the catheter in order to support it. The leader should not be passed
`beyond the tip of the catheter.
`This technique is simpler than appears on paper and after a little
`practice should present no difficulties. It is important that the leader
`passes into the artery easily. JVhen the tip of the catheter enters the
`artery, the same resistance is often felt as when puncturing is perfarmed
`
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`ENDOHEART AG, EX. 2001 Page 5
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530
`
`

`
`372
`
`SVEN IVAR SELDlNGER
`
`b.
`a.
`Fig. 4. Left-sided ectopic kidney in pelvis. (Right kidney absent.) Blood supply by
`one artery from the iliac bifurcation and one from the left internal iliac artery. Catheter
`inserted through the right femoral artery with tip a t the bifurcation. a. Arterial phase.
`b. Capillary phase.
`
`by means of a needle. However, the resistance is generally but slight or
`may be completely absent. If considerable resistance be encountered,
`it is probable that the tip of the leader is obstructed and force must
`therefore never be applied.
`Polyethylene tubing is unfortunately not radio-opaque. For this
`reason, in aortography via the femoral artery, a small amount of contrast
`medium may be injected and followed by a test exposure. This will
`show the position of the catheter and also the exact situation of the
`renal arteries and of the iliac bifurcation. When the brachial artery is
`catheterized, the procedure is carried out in the fluoroscopy room and
`the leader used as an indicator of position; the catheter is then kept
`free from blood by the injection of saline solution.
`
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`ENDOHEART AG, EX. 2001 Page 6
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530
`
`

`
`CATllETER IW,I’LACEMI<NT OF THE NWDLE IN PERCUTAkEOUS ARTEklOGRAPIIY
`
`373
`
`Pig. r).
`(la\c~rnoris nngionias of thr
`11ed -4rterial phasr. Catheter inserted
`through the fwioral artery with tip in
`the popliteal artery. The difficult p n c -
`ture of the popliteal artery was replaced
`Ily the easily perfornircl catheterization
`from the ingiiiii:il region.
`
`Fig. 6. Occlusion of the right external iliac
`artery. Collaterals from the superior gluteal to
`the deep femoral artery. Jnner part of the thigh
`supplied from the inferior gluteal artery. Catheter
`inserted through the left femoral artery with
`tip a t the bifurcation. G. cr. = superior gluteal
`artery. G. mud. = inferior gluteal artery. P. f. :
`deep femoral artery.
`
`S11tllIlli1ry of Inrestigatioiis l’erforined
`10 arterial cathetcriz:Ltions have been carried out; of these, 35 were aortographies
`via the femoral artery, 3 subclavian arteriographies by means of puncture of the brachial
`artery in the antecubital fossa, and 2 catheterizations of the femoral artery in a distal
`tlirection. In no case was general anaesthesia employed. Injection was made throughout by
`hand. The contrast medium used was 30 cc of Umbradil in each irijection with a concen-
`tration of 35 o/o in peripheral arteriographies and 70 yo in aortographies except in those
`cases in which compression of the femoral arteries was used, when a 50 yo solution was
`t.mployed. The tubing used was in all cases No. 200 (internal diameter 1.40 mm, external
`diameter l.:)n mm) or No. 205 ( 1 . 5 7 mm and 2.08 mm). The latter seemed to be the op-
`timal one for aortograpliy. As the thickness of the wall of the needles available is nearly
`
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`ENDOHEART AG, EX. 2001 Page 7
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530
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`

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`374
`
`SVEN IVAR SELDIXBEK.
`
`Fig. 7. Catheter inserted through the antecubital artery of both sides.
`The tip in the subclavian artery. (The metal tip is no longer in use.)
`The left inferior thyroid artery forks into two branches, the termina-
`tions of the longer and 1owr.r one of which run in a markwl curve dowti-
`wards and laterally as if around a tumour: examination of a resected
`part of the left lower lobe of the thyroid showed adenoniatous para-
`thyroid tissue in the parenchyma.
`
`the same as that of the catheter, a needle of 2 mm outer diameter is required. If the
`catheter is 40-45 cm long it permits a faster iiijection of the contrast nittlium than the
`12-15 mni needle of 1 niin lumen, used in this department €or translumbar aortography.
`25 catheterizations were performed by the author atid 1.5 by four other workers
`in the department.
`In one patient catheterization did not succeed, in spite of 3 atteinpts on the ftmoral
`arteries. as sufficient blood-flow through the catheter was not obtained. In one patient
`no attempt a t catheterization was made as resistance to the leadw was encountered.
`I n one obese patient, introduction of the catheter into the right femoral artery failed.
`but was carried out without difficulty on the left side. In the other cases the cathetri
`was inserted easily a t the first puncture and the investigation resulted in good filiiis
`excepting in two cases in which the tip of the catheter did not reach the level required.
`In one of the paticntr, 75 years old, resistance was encountered after 6-7 cm, and in
`another the deep femoral artery instead of the superficial one. was persistently catheter-
`ized.
`In 6 of the aortographies and in the 3 subclavian arteriographies the catheter was
`fitted with a metal tip (Pig. 7), but this was abandoned I)ec.:iuse it was found easirr t o
`
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`ENDOHEART AG, EX. 2001 Page 8
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530
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`

`
`CATLIRTER RISl’LACEMEXT 01?’ T H E KEEDLE I N PERCUTANEOUS ARTENIOQRAI~HP 375
`
`Fig. 8. Saturiil size. The middle needle permits, with the
`technique described, the insertion of a catheter (in this case
`No. 203) which requires R needle of the size of that pictured
`on the Icft, were it to be passed through the lumen of the
`needle. The same relative advantage exists between the right
`:tilt1 niitldle needles.
`
`insert the catheter without it, and the artery wall sometimes contracted around it
`during its renioval. Furthermore, it was realized that it might damage the arterial wall
`as happened in one of the subclal ian arteriographies, so that part of contrast medium
`was injected extmvascularly.
`As regards complications any tendency t o bleed a t the site of puncture was unini-
`portant and was mostly observed in elderly patients. No haematoma of clinical conse-
`quence e\ er formed. No thrombosis or any kind of circulatory disturbance in the region
`of the artery punctured was observed. There was no case of extravascular injection
`except the one previously mentioned. In the unsuccessful attempts a t catheterization.
`the leader probably passed through the posterior wall of the artery or its intima via a
`hole made during puncture. In these cases the needle could not be pushed far enough
`u p into the artery. In neither did the patient suffer any ill effects. No kinking or rupture
`of the catheter, or arterial spasin around it occurred. After local anaesthesia, the patients
`felt nothing during the manipulations and following the injection of the contrast medium
`thrre was, with intlividual variations, only the wellknown, rapidly passing discomfort.
`In one case the patient was operated on two weeks after bilateral femoral cathe-
`terization and both arteries were exposed. Traces of blood under the fascia intlicated
`the situation, but the exact site of puncture could not be discerned.
`Figs. 3-7
`form representative illustrations.
`
`Discussion
`The advantage of the author’s method of percutaneous cstheteriza-
`tion is the smaller size of needle required for a given catheter. As the
`catheter needs a certain clearance to enable it to glide through the bore
`of a needle, the difference is more marked than would appear from the
`thickness of the material (Fig. 8).
`In other words, a larger catheter can be inserted by the same sized
`needle. POISEUILLE’S
`law states that when pressure and viscosity are con-
`stant, the rate of flow through narrow tubes is:
`inversely proportional to the length of the tube, and
`directly proportional to the 4th power of the radius of the tube.
`This shows the dominant influence of the cross section of the catheter.
`Catheter No. 205, used here for abdominal aortography, has an inner
`If a pressure
`diameter, corresponding to a heart catheter No. 9-10.
`
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`ENDOHEART AG, EX. 2001 Page 9
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530
`
`

`
`3 T G
`SVEN IVAR PELDINOER
`apparatus were used, the gauge might doubtlessly be diminished con-
`siderably, i. e. to a size No. 160, corresponding t o a heart catheter No. 8,
`and which may be inserted with the help of a needle, 1 . 5 mm in external
`diameter.
`Though the extra manipulation with the leader is a disadvantage,
`it is very quickly performed. Furthermore, there is a little risk that the
`leader, when handled unskilfully, will pass through the posterior wall of
`the artery, although, no doubt, experience and improved equipment
`will eliminate this possible complication and avoid failure.
`
`SUMMARY
`The author describes a method by which it is possible, after percutaneous puncture,
`to insert a catheter of the same size as the needle used into an artery.
`Z U S A M M E N F .i4 S S U N G
`Der Verf. beschreibt eine Methode, die es ermoglicht, nach perkutaner Punktion
`rinen Katheter von derselben Grosse wie die benutzte Nadel in eine Arterie einzufiihren.
`R E S U M E
`L’auteur decrit une methode qui permet, a p r b ponction percutanee, d’introduire
`dans une artbe un catheter de m&me calibre que l’aiguille utilisde.
`
`L I T E R A T U R E
`DONALD, D. C., KESMODEL, K. F., ROLLINS, S. L. and PADDISON, R. M.: An improved
`technic for percutaneous cerebral angiography. Arch. Neurol. and Psych. 65 (1951),
`508.
`FARIGAS, P. L.: A new technique for the arteriographic examination of the abdominal
`aorta and its branches. Am. J. Roentgenol. 46 (194l), 641.
`JONSSON, G.: Thoracic aortography by means of a cannula inserted percutaneously into
`the common carotid artery. Acta radiol. 31 (1949), 376.
`PEIRCE, E. C.: Percutaneous femoral artery catheterization in man with special reference
`to aortography. Surg., Gynec. & Obst. 93 (1951), 56.
`RADNER, S.: Intracranial angiography via the vertebral artery. Preliminary report of a
`new technique. Acta radiol. 28 (1947), 838.
`
`h
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`ENDOHEART AG, EX. 2001 Page 10
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00299, U.S Patent No. 8,182,530