`Exhibit 1009
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`Page 1 of 11
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`11111
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`111111111111,111111,111p1111.11111111111111111011
`
`(12) United States Patent
`Niazi
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 6,638,268 B2
`Oct. 28, 2003
`
`(54)
`
`(76)
`
`( * )
`
`(21)
`(22)
`(65)
`
`CATHETER TO CANNULATE THE
`CORONARY SINUS
`Inventor: Imran K. Niazi, 9080 Upper River Rd.,
`River Hills, WI (US) 53217
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 150 days.
`
`Notice:
`
`Appl. No.: 09/828,502
`Filed:
`Apr. 6, 2001
`Prior Publication Data
`US 2001/0052345 Al Dec. 20, 2001
`
`Related U.S. Application Data
`(60) Provisional application No. 60/195,701, filed on Apt. 7,
`2000.
`Int. C1.7 ......................................... Afi 1 N1 25/098
`(51)
`(52) U.S. Cl. ...................... 604/528; 6041578; 6[14:'523;
`604/530; 604/164.01; 604/26 , 609:'06.01
`(58) Field of Search .............................. 601 528, 523,
`604/164.01, 530, 264, 266, 96.01, 93.01,
`95.01
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
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`12/1988 Skrikiski .............
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`[989 Lovgren et al. ......
`5,290,229 A * 1 1994 Paskar .................
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`8 1994 Lundquist et al. ....
`5,505,698 A * 4 1996 Booth et al. ..........
`1996 Stevens et al. ........
`1
`5,584,803 A
`5,643,231 A
`7`1997 Lurie et al. ...........
`5,690,611 A
`11.1997 Swartz et al. .........
`5,782,741 A
`7/1998 Bradshaw et al. ....
`
`604/290
`604/280
`604/95
`604195
`604/96
`604/4
`6040.82
`604153
`600/3
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`13
`
`606/41
`7/1998 Bednarek ..............
`5,785,706 A
`600/374
`9'1 )98 Qin et al. .............
`5,807249 A
`1.521.031 A * 1(1-1Q98 Cookston et al. ......
`607:122
`5.846.279 A * 1211 1198 Berg ...................
`604:281
`60i):373
`5,870205 A
`3:1999
`Li et al. ...............
`,,._010 _214 A
`(,;) ,)99
`600/41
`Cosio et al. ..........
`12;11199
`6.1101.085 A
`60'1:282
`Lurk et al. ...........
`600:374
`12,1799
`Wilkins et al. ........
`01x12.955 A
`17.1 (11.137 A ° 12,1799 Williams ..............
`607:119
`6.022.311 A * 2;2.000 Lentz ...................
`604:523
`6.080.1f-.1 A
`6116/45
`60000 Swartz et al. .........
`7.21100 Bassett et al. ........
`600:281
`6.000,084 A
`F. 7[2000 Balceta et al. ........
`1,093,173 A
`604:164
`607..116
`9[2000 Tockman el al. ......
`0.127.52 A
`6.170.809 B1 ° 1:2001 Khairkhahan et al. ... 604/05.01
`0228,052 B1 ° 5:2001 Pohndorf .............. 604/00.01
`6,273,581 Bl * 8/2001 Kkmeneij ............
`604/532
`2002/0103474 Al ° 8/2002 Voda ....................
`604/530
`* cited by examiner
`Primary Examiuer—Ira S. Lazarus
`Assisrrrrrr Exammer—Tu Cam Nguyen
`(74) Attorney, Agent, or Firm—Philip G. Meyers
`ABSTRACT
`(57)
`A double catheter includes an outer, resilient catheter having
`shape memory and a hook-shaped distal cnd, art inner,
`pliable catheter slidably disposed in the outer catheter and of
`greater length than the outer catheter so that a distal end
`portion of the inner catheter can be extended or retracted
`from a distal end opening of the outer catheter to vary the
`overall length of the double catheter, the inner catheter
`pre lerably having an internal lumen suitable for the intro-
`duction of contrast media, and a mechanism operable from
`the proximal end of the outer catheter for chaNing the
`curvature of the hook shaped distal end of the outer catheter.
`Such a catheter of the invention can cannulate the coronary
`sinus without significant manipulation.
`27 Claims, 5 Drawing Sheets
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`1
`CATHETER TO CANNULATE THE
`CORONARY SINUS
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`15
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`This application claims priority of U.S. Provisional
`Application No. 60/195,701, filed Apr. 7, 2000.
`FIELD OF THE INVENTION
`This invention relates to medical devices, particularly to
`catheters of the type used to cannulate the coronary sinus.
`BACKGROUND OF THE INVENTION
`The coronary sinus is a venous structure that is three to
`four centimeters in length and one centimeter in diameter. It
`forms a part of the venous drainage of the heart. The
`coronary sinus arises from the posterior inferior aspect of the
`right atrium and courses over the posterior surface of the
`heart, ending in the great cardiac vein, It is the final common
`venous drainage of most of the heart.
`Cannulation of the coronary sinus has until recently not
`been considered important from a medical viewpoint. Medi-
`cal researchers have cannulated the coronary sinus in ani-
`mals and in humans to obtain information about the func-
`tioning of the heart. Cardiac surgeons will, during cardiac
`surgery, cannulate the coronary sinus for retrograde car-
`dioplegia. However, routine cannulation of the coronary
`sinus is not performed when there is no therapeutic advan-
`tage to performing coronary sinus angiography.
`It has recently become apparent that the coronary sinus
`and its branches can be used to place catheters (fine pacing
`catheters) on 1 he. epicardium of the. left ventricle. The left
`ventricle can Mtn be paced via these catheters. Preliminary
`studies show that pacing the left ventricle produces signifi-
`cant benefit in patients with heart failure, especially those
`with conduction disturbances. Therefore, studies are under-
`way to study the coronary sinus anatomy and place the
`pacing catheters in the appropriate branch of the coronary
`sinus. Unlike for coronary arterial circulation, which has
`been well studied because of its therapeutic benefit, there are
`no presently available preformed catheters that will slip
`easily into the coronary sinus. U.S. Pat. No. 5,423,772
`exemplifies one proposed device designed for use in the
`coronary sinus wherein the catheter has a double curve.
`Congestive heart failure is one of the commonest diag-
`noses leading to hospital admission in the United States. a5
`There are 2 to 5 million patients diagnosed with CHF in the
`U.S. annually, and 15 million worldwide. Treatment of heart
`failure consists of medications, and cardiac transplantation
`in severe cases. Other forms of surgery, e.g. valve surgery,
`are also sometimes helpful. Attention, has recently focused 50
`on resynctironization therapy. About 30-50% of people with
`severe CHI have asynchronous contraction of the cardiac
`chambers, 'Ibis can be corrected by pacino, the right atrium,
`the right ventricle and the left ventricle at optimal intervals
`to provide synchrony. Leads to pace the right atrium and 56
`right ventricle have been used for years. Recently, leads have
`been devised to pace the left ventricle by passing the lead
`through the coronary sinus into a branch vein that overlies
`the left ventricle. Delivery systems to guide the leads into
`the appropriate branch veins are now being researched.
`Currently available catheters and catheter systems have
`several disadvantages which render lead delivery difficult.
`For example, the anatomy of the right atrium and the
`coronary sinu s origin is different in patients with congestive
`heart failure than in patients with normal sized hearts. These 65
`differences in part form the basis for the design of the
`delivery system of the present invention. Such differences
`
`2
`include that the os of the coronary sinus lies higher in the
`right atrium in such persons than in normal persons. The
`eustachian ridge is unusually prominent, and the right atrium
`is usually larger than normal. Subeustachian fossae are more
`well developed in the large right atria. There is great
`variation in the size of the coronary sinus and its shape and
`direction, and the target coronary branch veins arise at acute
`angles from the main coronary sinus in many patients. This
`renders it difficult to pass a lead into these branches. Venous
`valves obstruct the passage of the lead. These are variably
`placed, frequently close to the origin of the coronary veins.
`The present invention provides a catheter especially adapted
`for use in the coronary sinus, especially in patients suffering
`from congestive heart failure.
`SUMMARY OF THE INVENTION
`A double catheter according to one aspect of the invention
`includes an outer, resilient catheter having shape memory
`and a hook-shaped distal end configured for cannulation of
`the coronary sinus, an inner, pliable catheter slidably dis-
`posed in the outer catheter and of greater length than the
`outer catheter so that a distal end portion of the inner
`catheter can be extended or retracted from a distal end
`opening of the outer catheter to vary the overall length of the
`double catheter, the inner catheter preferably having an
`internal lumen suitable for the introduction of a fluid, such
`as contrast media, into the coronary sinus and also for
`passage of a pacing lead, and a mechanism operable from
`the proximal end of the outer catheter for changing the
`curvature of the hook shaped distal end of the outer cat heter.
`Such a catheter of the invention can cannulate tfie coronary
`sinus without significant manipulation, enable an angiogram
`of the coronary sinus by means of an occlusive balloon
`which includes the proximal coronary sinus at the time of
`contrast media injection, serve as a conduit for the passage
`of a fine coronary sinus pacing lead (5 French in diameter),
`provide backup support for introducing this lead over a
`guide wire into the distal branches, and minimize the steps
`necessary for the placement of a coronary sinus lead, thereby
`allowing rapid introduction of such a lead.
`The invention further provides a method of using a
`catheter to place a pacing lead in a transverse branch of the
`coronary sinus in order to treat a related condition such as
`congestive heart failure. Such a method for placing an
`electrical lead in a lateral branch of a coronary sinus vein
`using a double catheter includes the steps of inserting the
`catheter into the coronary sinus, advancing a guide wire
`through the catheter into a coronary sinus lateral branch
`vei n, advancing the inner catheter out of a front end opening
`of the outer catheter along ifie guide wire into the branch
`vein, inserting the lead through the outer and inner catheters
`to a target location in the branch vein, and withdrawing the
`catheter leaving the lead in the. branch vein. It necessary, the
`curvature of the double catheter can be adjusted in order to
`enter the coronary sinus. These and other aspects of the
`invention are discussed in the detailed description that
`follows.
`BRIEF DESCRIPTION OF THE DRAWING
`In the accompanying drawing, wherein like numeral
`denote like elements:
`FIG. 1 is a side view of a double catheter of the invention;
`FIG. 2 is a side view of the outer catheter of FIG. 1;
`FIG. 3 is a side view a second embodiment of a catheter
`according to the invention;
`FIGS. 4 and 5 are diagrams illustrating preferred shapes
`for the outer guide and obturator of FIG. 3;
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`3
`FIG. 6 is a diagram illustrating an alternative inner
`catheter for use in the embodiment of FIG. 3; and
`FIGS. 7 and 8 are diagrams illustrai ing use of the catheter
`of FIG. 3 a method of introducing a pacing lead according
`to the invention.
`DESCRIPTION OF PREFERRED
`EMBODIMENTS
`FIGS. 1 and 2 illustrate a double catheter 10 according to
`the invention having a typical length of 60 cm. An outer
`catheter 11 is made of a braided silastic or similar material
`to allow torque control and stiffness. An inner catheter 12,
`which slides in and out of outer catheter 11, is constructed
`of a more pliable, soft material such as silicone. The
`combinat ion of outer and inner catheters 11, 12 provides a
`number of advantages, including variability in the reach of
`the catheter, and outer catheter stiffness necessary for
`manipulation along with inner catheter softness, which
`permits safe cannulation of the coronary sinus and advance-
`ment of catheter 11 into the distal coronary sinus for
`purposes of support. It also allows the inner catheter 12 to
`conform to the torturous course of a coronary sinus.
`Inner catheter 12 fits into lumen 15 of outer catheter 11,
`and is preferably coated with a hydrophilic lubricious mate-
`rial which allows catheter 12 to slide in and out of outer
`catheter 11 with ease. A proximal end 13 of inner catheter 12
`terminates in a hemostatic valve 14 having an adjustable
`diaphragm. Valve 14 prevents leakage of blood when a 5
`French pacing lead is introduced through inner catheter 12
`into the coronary system. Preferably, a distal end 16 of inner
`catheter 12 has a tip 17, for example, about 1 cm long, made
`of a material softer than the remainder of inner catheter 12.
`This may, for example, he accomplished by making tip 17
`thinner than the remainder of catheter 12, or by making a
`bilayered inner catheter 12 wherein the one layer extends
`further than the other to form the tip and optionally is made
`of a material softer than that of the other layer.
`Outer catheter 11 has several functions. Because of its
`stiffness and torque, it can be manipulated in the right atrium
`to allow cannulat ion of the coronary sinus. Such stillness
`also lends support to the pacing lead as it is introduced into
`the distal coronary sinus. A distal end 18 of outer catheter 11
`has an external inflatable cuff or balloon 21. Balloon 21 can
`be inflated with air by means of a syringe 22 connected to
`balloon 21 as described below. Inflation of balloon 21 allows
`occlusion of the proximal coronary sinus, which is necessary
`for obtaining a coronary sinus angiogram.
`The proximal end of outer catheter 11 has several features.
`A port 26 including a shutoff valve 30 is provided for 50
`introduction of air into balloon 21. This port 26 is connected
`by means of a passage 27 in the wall of catheter H with the
`distal balloon 21. A torque coupling 28 of a type known in
`the art may be tightened down on inner catheter 12 to
`prevent it from moving within outer catheter 11. A torque 55
`screw 29 is attached to a cable or wire 31 that runs in the
`wall of outer catheter 11 and may be wound over one or
`more small rounded corners or small pulleys 35 set in the
`wall of catheter 11. This cable 31 is anchored, as by
`embedding a enlarged end thereof, at a point 34 close to a tip 50
`32 of outer catheter 11. Rotation of torque screw 29 causes
`cable 31 to be retracted, which changes the shape of the
`outer catheter 11 (making the hooked shape more pro-
`nounced as shown by the arrow) and counter-rotation does
`the opposite. Torque screw 29 may, for example, comprise 65
`a spool or reel having an external circumferential groove on
`which cable 31 is attached and is wound or unwound as
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`needed. A port 36 with an associated shutoff valve 37 is
`provided through the wall of outer catheter 11 for delivering
`a saline flush through lumen 15.
`For optimum deployment in the coronary sinus, inner and
`outer catheters 11,12 preferably have a predetermined shape
`and a certain degree of stitliess to maintain such shape
`during man ipulation in the heart, but still flexible enough to
`bend when required. As shown in FIG. 2, the hook-shaped
`distal end of outer catheter 11 may comprise substantially
`straight segments spanning three bends 41, 42 and 43. First
`bend 41 adjoining a straight, proximal portion 44 of outer
`catheter 11 is in ihe ra nge. of about 130° to 1S0°, especially
`130° to 175°. Second, intermediate bend 42 extends in a
`direction opposite bend 41 and is in the range of about 75°
`to 100°. Third bend 43 near the distal end of outer catheter
`11 extends in the same direction as bend 42 and is in the
`range of about 130° to 175°. These ranges refer to the angle
`formed by the straight segments adjacent each bend when
`the catheter is in an undistorted state. Operation of the
`deflection device to tighten the cable will reduce these
`angles, especially for second bend 42. The material of which
`outer catheter 11 is made, e.g. silastic, has sufficient shape
`memory to return to its original shape when undistorted. The
`undistorted shape of outer catheter 11 can be varied and
`catheter 10 thereby made in several sizes to accommodate
`different heart sizes. For example, for a normal size atria
`with a prominent Eustachian valw, outer catheter 11 may be
`substantially 1-shaped with no first bend (bend 41=180°),
`whereas for large atria with a prominent Eustachian valve, it
`may be useful to make. catheter 11 more in a question mark
`shape. (shown inverted in I1GS. 1-2).
`Coronary sinus catheter 10 may be deployed in the
`following fashion. Distal balloon 21 is deflated, inner cath-
`eter 12 is withdrawn completely into outer catheter 11, and
`catheter Ill is inserted through a venous sheath introduced in
`the left XX subclavian vein. It is guided into the right atrium
`over a guide wire, and the guide wire and sheath are then
`removed. Catheter 10 is rotated until tip 17 lies within the
`tricuspid valve, then advanced until tip 17 is seen to lie in the
`inferior-most portion of the tricuspid valve. If the reach of
`catheter 10 in this configuration is not sufEcient to cannulate
`the tricuspid valve, then inner catheter 12 is advanced out of
`outer catheter 11 to make the entire system longer.
`Subsequent manipulation is carried out in a left anterior
`fluoroscopic view•. Counterclockwise torque is exerted on
`catheter 10. At the same time, inner catheter 12 is gradually
`withdrawn. Eventually, catheter 10 slips over the tricuspid
`annulus and, because of the counterclockwise torque, twists
`and pops into the proximal coronary sinus. In some
`instances, it may come to lie at the mouth of the proximal
`coronary sinus. In that case, inner catheter 12 is gradually
`advanced until the coronary sinus is cannulated. Once the
`coronary sinus is cannulated, inner catheter 12 is advanced
`as far as it will go into the coronary sinus and/or great
`cardiac vein. Distal balloon 21 on outer catheter 11 is
`inflated using syringe 22 to occlude the proximal coronary
`sinus. Contrast medium is injected via a port 25 through the
`lumen of inner catheter 12 to obtain a coronary sinus
`angiogram. Port 36 is then hooked up to a saline flush. A
`coronary sinus lead is introduced through a he most a xis valve
`14 into inner catheter 12. It is positioned using a guide wire
`in an appropriate branch of the coronary sinus.
`A triple catheter 50 according to the invention is designed
`to overcome the nlistacics described above that are encoun-
`tered with congestive heart failure patients and further
`provide a more economical catheter system that does not
`rely on specialized miniature adjustment mechanisms. The
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`system includes an outer guide catheter 51, an inner guide
`catheter 52 nested therein, an obturator 53 nested inside the
`inner guide 52. In one example, outer gu iding catheter 51 is
`2.9 mm in outer diameter, 2.6 mm inner diameter. It is
`relatively stiff and has a braided design, which lends support
`and one-for-one torque control. In this respect, it can
`resemble an angioplasty guiding catheter. The shape of outer
`guiding catheter 51 is similar, but not identical, to a left
`amplatz curve. The proximal end terminates in an screw-
`adjusted hemostatic valve 56, to allow introduction of leads
`or wires of different diameters without leakage of blood.
`There is also a side -port 58, preferably with a 3-way valve,
`to allow injection of contrast medium and saline.
`Inner guiding catheter 52 made of a soft, pliable material
`such as silicone, and in this example is 2.6 mm in outer
`diameter and 2.3 mm in inner diameter. It has no longitu-
`dinal braiding, which makes it extremely flexible and able to
`conform to various shapes. Inner catheter 52 is designed to
`advance over a guide wire into a side branch of the coronary
`sinus, in conjunction with the obturator 53. Its flexibility
`allows it to negotiate tortuous vessels and side branches that
`originate from the coronary sinus at an acute angle, yet it still
`possesses the radial strength needed to prevent it from
`collapsing when obturator 53 is withdrawn. timer guide 52
`is longer than outer guide 51, e.g., 68 cm in length. The
`proximal end of guide 52 has a hemostasis valve 57 to
`prevent back bleeding and a side port 59 to permit contrast
`medium injection.
`Obturator 53 is preferably made of very pliable silicone,
`and has a central lumen that will accommodate an 0.038 inch
`guide wire. Obturator 53 fits into inner guide 52, and in one
`embodiment is 70 mm long, 2.1 mm in outer diameter
`tapering to 1.25 mm diameter at its tip. In use, obturator 53
`tracks over a 0.038" guide wire 81 into a targeted side branch
`56, in concert with the inner guide catheter 52. A tapered tip
`71 of obturator 53 may protrude from the front end opening
`of inner catheter 52, Without such a protruding tip 71, the
`edge of inner catheter 52 might catch on venous valves or
`sharp angles. The terminal 7 mm of obturator 53 may have
`a bend 72 therein of up to about 30 degrees, i.e., defining an
`angle from 150-180 degrees. This allows tip 71 to function
`as a guiding device for the 0.038" gu id e wire 81, which can
`then be directed into acutely angled side branches. The
`proximal end of- obturator 53 terminates in a standard port 60
`allowing attachment of a 10 cc syringe.
`Referring to FIGS. 7 and 8, outer guiding catheter 51 is
`initially connected to a syringe and pressure monitoring
`system and then inserted into the right atrium 80, The
`physician attempts to use it to cannulate the coronary sinus
`without the use of the other components. If this succeeds, an 50
`0.038" hydrophillic-coated guide wire 81 is advanced
`through it, and used to cannulate the target lateral coronary
`sinus side-branch 56. (If the side branch 56 cannot be easily
`cannulated, the angled obturator 53 can be extended and
`used to direct the guide wire 81 as illustrated in FIG. 7.) The 55
`inner guide 52, with obturator 53 inside, is then passed
`through outer guide 52 over the 0.038" wire into the target
`side branch 56. Obturator 53 is then withdrawn, and an
`electrical lead 83 is then advanced through the catheter over
`a 0-014" guide wire 82 to its final rest ing place in the target 60
`branch 56, and ultimately connected to a pacemaker after the
`catheter is withdrawn in order to apply electrical heart
`stimulation to that location. Guide wire 82 is only used if
`needed; it may he possible to place lead 83 without it.
`An advantage of this three-part system is that it allows a 65
`standard lead (not an over-the-wire design) to be positioned
`in a transverse branch 56 which has a relatively sharp
`
`6
`angulation at its origin from the main coronary sinus.
`Although not deflectable using an screw adjustment mecha-
`nism as described above in connection will" the first
`embodiment, this embodiment can nevertheles,, be used to
`cannulate the coronary sinus whether the latter is placed
`normally, higher than normal, or lower than normal. The
`angle of outer guide 51 can be changed by inserting or
`withdrawing the inner guide 52. Inserting inner guide 52
`without obturator 53 before cannulation straightens outer
`10 guide 51, i.e., makes the angle of the outer guide 51
`shallower, allowing engagement of a lower origin of the
`coronary sinus. Inserting both obturator 53 and inner guide
`52 makes the outer guide angle even shallower. Thus, the
`outer guide alone, the outer guide plus inner guide, and outer
`guide plus inner guide plus obturator can be used as needed
`to cannulate coronary sinuses of varying heights of origin.
`This three-part telescoping embodiment thus eliminates
`the need for a cable system to change the curvature of the
`catheter during manipulation As shown in FIG. 4, outer
`guide catheter 51 preferably has three bends in a manner
`similar to outer catheter 11, with the first or proximal bend
`61 ranging from about 150-180 degrees, the second
`(middle) bend 62 ranging from about 120-180 degrees. and
`the third proximal bend from 90 to 160 degrees in a direction
`opposite to that of the other two bends, as shown. Inner
`guide catheter 51 preferably has three bends in a manner
`similar to the outer catheter 11, with the first or proximal
`bend 61 ranging from about 150-180 degrees, the second
`(middle) bend 62 ranging from about 120-180 degrees, and
`the third proximal bend 63 from 90 to 160 degrees in a
`direction opposite to that of the other two bends. as shown.
`In one preferred form, outer guide 51 is 9 1 a:nch diameter,
`60 cm length, inner guide 52 is made of a snit material 8
`French diameter, 68 cm length, and obturator 53 is 5 French
`diameter, 75 cm length.
`Referring to FIG. 5, obturator 53 stiffens and shapes inner
`guide 52 when inside of it. It may be pre-formed with a right
`angle bend 54 as shown to conform more easily to the shape
`of outer guide 51, but this is not essential. However, tip 71
`of obturator is 53 bent to an angle in the range of about
`150-180 degrees to better aid in introducing a lead into a
`transverse vein as described above. Obturator 53 preferably
`tapers to a blunt point having a small opening therein just
`large enough to admit the largest size guide wire to he used
`in the procedure, in this example, 0.038 inch.
`In an alternative version of catheter 50, the radial strength
`of the inner guide or catheter 52 prevents its collapse when
`obturator 53 is withdrawn. For this purpose, as shown in
`FIG. 6, a bend 56 in inner guide 52 is reinforced with a
`helical wire coil 55 that is embedded therein, or a series of
`spaced wire rings or hoops. These hoop reinforcements
`prevent inner guide 52 from collapsing during withdrawal of
`obturator 53 but do not prevent inner guide 52 from bending
`in a flexible manner.
`The claims which follow define certain aspects of the
`invention but do not limit the invention. It will be evident,
`for example, that a catheter according to the invention can
`be used to reach other hard to access parts of the human
`body, both in the heart and elsewhere, due to its unique
`structure.
`What is claimed is:
`1. A double catheter, comprising:
`an outer, resilient catheter having shape memory and a
`hook shaped distal end configured for cannulation of
`the coronary sinus with at least one curved bend;
`an inner, pliable catheter slidably disposed in the outer
`catheter and of greater length than the outer catheter so
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`US 6,638,268 B2
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`8
`advancing a guide wire through the catheter into a coro-
`nary sinus lateral branch vein;
`advancing the inner catheter out of a front end opening of
`the outer catheter along the guide wire into the branch
`vein;
`inserting the lead through the outer and inner catheters to
`a target location in the branch vein; and
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`withdrawing the catheter leaving the lead in the branch in
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`to
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`that a distal end portion of the inner catheter can be
`extended or retracted from a distal end opening of the
`outer catheter ID vary the overall length of the double
`catheter, the inner catheter having an internal lumen
`configured for the introduction of contrast media and a
`pacing lead into the coronary sinus; and
`a mechanism operable from the proximal end of the outer
`catheter for changing the curvature of the distal end of
`the outer catheter.
`2. The double catheter of claim 1, wherein the mechanism
`for changing, the curvature of the hook shaped distal end
`further comprises an obturator slidably ;lisposed inside of
`the inner catheter, wherein the ohturator is configured to
`reduce the curvature of the hook shaped distal end when
`inserted in the inner catheter.
`3. The double catheter of claim 1, further comprising a
`balloon mounted on the outside of the distal end of the outer
`catheter positioned for occlusion of the proximal coronary
`sinus, and a conduit permitting inflation of the balloon at the
`proximal end of the outer catheter.
`4. A double catheter, comprising:
`an outer, resilient catheter having shape memory and a
`hook-shaped distal end with at least one curved bend;
`an inner, pliable catheter slidably disposed in the outer
`catheter and of greater length than the outer catheter so
`that a distal and portion of the inner catheter can be
`extended or retracted from a distal cud opening of the
`outer catheter to vary the overall length of the double
`catheter, the inner catheter having an internal lumen
`suitable for the introduction of a fluid therethrough; and
`a mechanism operable from the proximal end of the outer
`catheter for changing the curvature of the distal end of
`the outer catheter, wherein the mechanism for changing
`the curvature of the hook shaped distal end comprises
`a cable anchored to the outer catheter at a point
`proximate the distal end of the outer catheter and at a
`point proximate the proximal end of the outer catheter,
`whereby shortening of the cable from the point proxi-
`mate the proximal end of the outer catheter results in
`increased curvature of the hook shaped distal end.
`5. The double catheter of claim 4, wherein the cable runs
`inside a
`of the outer catheter.
`6. The double catheter of claim 1, further comprising a
`mechanism operable from a proximal end of the outer
`catheter for securing the inner catheter against sliding move-
`ment relative to the outer catheter.
`7. The double catheter of claim 6, further comprising a
`port for introducing a fluid into a space between the inner
`and outer catheters.
`8. The double catheter of claim 1, wherein the hook-
`shaped distal end comprises substantially straight segments
`spanning three bends.
`9. The double catheter of claim 8, wherein a first bend
`adjoining a straight, proximal portion of the outer catheter is
`in the range of 130° to 175°, a second, intermediate bend is
`in the range of 75° to 100°, and a third bend nearest the distal
`end of the outer catheter is in the range of to 130° to 175°.
`10. The double catheter of claim 1., wherein the mecha-
`nism for changing the curvature of the hook shaped distal
`end comprises a portion of the inner catheter configured to
`reduce the curvature of the hook shaped distal end when
`inserted in the outer catheter.
`11. A method for placing an electrical lead in a lateral
`branch of a coronary sinus vein using a double catheter
`including an outer catheter and an inner catheter slidably
`disposed inside the outer catheter, comprising:
`inserting the catheter into the coronary sinus;
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`3 5
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`12. The method of claim 11, further comprising:
`adjustini the curvature of the double catheter in order to
`enter the coronary sinus.
`13. An outer catheter configured for use with an inner,
`15 pliable catheter which can be slidably disposed in the outer
`catheter and of greater length than the outer catheter so that
`a distal end portion of the inner catheter can be extended or
`retracted from a distal end opening of the outer catheter, the
`outer catheter comprising a resilient tube having shape
`20 memory and sufficient stiffness to permit advancement of
`the outer catheter into a distal coronary sinus, and having a
`hook-shaped distal end wherein a first bend adjoining a
`straight, proximal portion of the outer catheter is in the range
`of 130° to 180°, a second, intermediate bend is in the range
`25 of 75° to 100° in a direction opposite the first bend, and a
`third bend nearest the distal end of the outer catheter in the
`same direction as the second bend is in the range of to 130°
`to 175°.
`14. The catheter of claim 13, wherein the first bend equals
`30 180°, rendering the outer catheter substantially J-shaped.
`15. The catheter of claim 13, wherein the first bend is in
`the range of 130-175°, rendering the outer catheter substan-
`tially question mark-shaped.
`16. The catheter of claim 13, wherein the outer catheter is
`made of a braided silastic.
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