United States Patent (19)
`Patton et al.
`
`11
`45
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`Patent Number:
`Date of Patent:
`
`4,886,507
`Dec. 12, 1989
`
`54 Y CONNECTOR FOR ANGIOPLASTY
`PROCEDURE
`75 Inventors: William E. Patton; William J.
`Lindsey, both of Dublin, Ohio
`73) Assignee: Medex, Inc., Hilliard, Ohio
`21 Appl. No.: 150,778
`22 Filed:
`Feb. 1, 1988
`51 Int. Cl."............................................. A61M 25/00
`52 U.S.C. ..................................... 604/284; 128/344
`58 Field of Search ............... 604/283, 284, 165, 166,
`604/167, 169, 158, 256; 128/344, 348.1
`References Cited
`U.S. PATENT DOCUMENTS
`4,254,773 3/1981 Waldbillig.
`4,311,137 1/1982 Gerard ................................ 604/284
`
`56)
`
`Spector et al. .
`4,424,833
`1/1984
`4,430,081
`2/1984
`Timmermans .
`4,626,245
`12/1986
`Weinstein .
`4,682,981
`7/1987
`Suzuki et al. ....................... 604/283
`4,723,550
`2/1988
`Bales et al. .
`4,726,374
`2/1988
`Bales et al. .
`4,769,017
`9/1988
`Fath et al. ..
`4,781,702
`11/1988
`Herrli.....
`Primary Examiner-John D. Yasko
`Attorney, Agent, or Firm-Wood, Herron & Evans
`57
`ABSTRACT
`A connector has a main passage through which a dilata
`tion catheter passes. Combined Tuohy-Borst valve and
`membrane seals are provided in the main passage to seal
`the catheter and main passage against flow-by.
`
`... 604/283
`... 604/284
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`6 Claims, 2 Drawing Sheets
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`U.S. Patent Dec. 12, 1989
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`U.S. Patent Dec. 12, 1989
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`Sheet 2 of 2
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`1.
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`Y CONNECTOR FOR ANGOPLASTY
`PROCEDURE
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`5
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`10
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`BACKGROUND OF THE INVENTION
`This invention relates to a Y connector for use in an
`angioplasty procedure.
`The angioplasty procedure for repair of a blood ves
`sel has been known for many years. The procedure
`provides an opportunity to open up a clogged blood
`vessel, particularly a coronary artery, and thus avoid
`the expense and trauma of bypass surgery.
`The procedure involves the insertion of a large guide
`catheter up to the blood vessel to be repaired. A Y
`15
`connector is attached to the free end of the guide cathe
`ter by means of a rotatable coupling of the type dis
`closed in U.S. Pat. No. 4,254,773. The Y connector has
`a main passage through which the dilatation catheter is
`inserted. The Y connector has a branch passage to
`which a multiport manifold is connected. One port of 20
`the manifold is connected to a blood pressure monitor
`of the type disclosed in copending application Ser. No.
`07/072,909, filed July 14, 1987. Another port of the
`manifold is connected to a supply of contrast media
`which is a fluid injected into the blood vessel enabling a
`25
`real time observation of the blood vessel through X-ray.
`At a minimum, the angioplasty procedure involves
`the following steps:
`The guide catheter is inserted through a blood vessel
`in the patient's arm or leg into the heart.
`30
`A blood pressure monitor is connected to the Y con
`nector to provide a continuous monitor of a patient's
`blood pressure.
`The contrast medium is introduced into the blood
`vessel so that the blockage of the blood vessel can be
`35
`identified.
`A dilatation catheter having a balloon on its free end
`is introduced through the main passage of the Y connec
`tor. When the end of the dilatation catheter is in place in
`the area of the blockage caused by a growth of placque,
`40
`a saline mixture is injected through the dilatation cathe
`ter to the balloon on its end to inflate it. As the balloon
`is inflated, it ruptures the placque in the coronary artery
`so as to permit normal or at least improved blood flow.
`The dilatation catheter is thereafter removed and
`45
`contrast medium again introduced and a post dilatation
`arteriogram is made to check the success of the proce
`dure.
`Thereafter, the dilatation catheter may be reintro
`duced. It may be desired to use a larger catheter. It may
`50
`be desired to introduce a small guide wire instead of a
`dilatation catheter.
`In any event, more than one insertion and withdrawal
`through the main passageway is normally required to
`complete the angioplasty procedure.
`Blood under normal body pressure is of course in the
`main passageway just as it is in the branch passageway
`where it is being continuously monitored. The blood
`will tend to escape through the main passageway as by
`directly flowing through the main passageway when a
`60
`catheter is removed or by flowing by the catheter when
`it has been inserted.
`It is known in the prior art to provide sealing against
`the escape of blood through the main passageway of the
`Y connector. One seal is an adjustable Tuohy-Borst
`type valve. The Tuohy-Borst valve includes an O-ring
`type element seated in a socket forming part of the main
`passage. A cap threaded on the end of the passage con
`
`4,886,507
`2
`tains a spigot which compresses the O-ring when the
`cap is rotated to drive the spigot inwardly. The com
`pression closes down the opening in the O-ring around
`the catheter to prevent “flow-by.” When the catheter is
`absent, the O-ring can be closed down enough to com
`pletely close off the opening in the main passage.
`An alternative form of seal employs a membrane
`having a small hole of about 0.045' diameter. Catheters
`of a slightly larger outside diameter than the hole are
`inserted through the membrane, the membrane forming
`the seal against "flow-by.”
`Neither Y connector seal is completely satisfactory.
`The Tuohy-Borst has the disadvantage that it requires
`manipulation in order to match the size of the opening
`in the ring to the outside diameter of the dilatation
`catheter. If the cardiologist does not tighten it suffi
`ciently, blood will flow by the valve. If it is too tight,
`the catheter can be inserted only with difficulty because
`of the friction or the catheter can be crushed.
`The membrane-type seal eliminates the foregoing
`disadvantages of the Tuohy-Borst valve but has its own
`disadvantages. It cannot be completely closed off when
`a catheter is removed. Under those circumstances,
`when the dilatation catheter is removed, the Y connec
`tor has to be removed and the manifold connected di
`rectly to the rotator. During this step, there is nothing
`to prevent the blood from flowing through the guide
`catheter and into the surgical area. Further, the smaller
`catheters, for example 0.036' O.D., cannot properly be
`sealed by a membrane that has a hole that is 0.045'
`diameter.
`BRIEFSUMMARY OF THE INVENTION
`It is an objective of the invention to provide anim
`proved seal for the Y connector, the improved seal
`eliminating the disadvantages of the Tuohy-Borst and
`membrane-type seals of the prior art.
`More specifically, it is an objective of the invention to
`provide a seal which permits insertion of the dilatation
`catheter without need for manipulation of the connec
`tor to effect the seal and which precludes blood flow
`by; and which permits all steps of the procedure to be
`performed without requiring the disconnection of the Y
`Connector.
`The objects of the present invention are attained by
`providing a Y connector having, in the main passage, a
`socket that receives a Tuohy Borst O-ring, a cap with a
`spigot projecting from it, the cap being threaded onto
`the outside surface of the socket so that it can be
`screwed down to bring the spigot into contact with the
`Tuohy-Borst ring to compress it. The cap has sealed
`into it a membrane having a 0.040' to 0.035" diameter
`opening for receipt of a catheter. The spigot and socket
`are provided with projecting and interfering collars or
`rims that limit the axial movement of the spigot out of
`the socket. The limitation is such that when the collars
`are touching, the spigot is in engagement with the
`Tuohy-Borst ring to hold it in sufficient compression to
`block flow of blood around the external surface of the
`ring, that is, between the ring and the socket. This rela
`tionship is important to maintain a seal against flow-by
`when the membrane is used for the seal. In the prior art,
`the cap containing the membrane is solvent-sealed to
`the connector. Such a seal is ruled out when it is neces
`sary to have the threaded connection for a Tuohy
`Borst-type operation. Therefore, the combination pro
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`4,886,507
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`4.
`vides a seal for the membrane-type procedure that does
`seat 38. The cross section of the O-ring 40 is trapezoidal.
`not require the solvent sealing.
`One surface 41 of the trapezoid sits on the seat 38. The
`The combination as described permits or facilitates a
`other surface 42 of the trapezoid is engaged by a frusto
`number of procedures that have heretofore not been
`conical surface 45 at the end of a spigot 46. The O-ring
`possible with any Y connector. The dilatation catheter
`has a circular opening which, in a relaxed condition, is
`can be inserted through the membrane and no manipula
`about 0.080 inch.
`tion is required to effect the seal between the membrane
`The spigot 46 is integral with a skirt 47 that surrounds
`and the catheter. The catheter can be removed and
`the socket 35 and has internal threads by which it is
`blood flow through the main passage blocked by tight
`threaded onto the threads 36 of the socket. The spigot
`ening down on the Tuohy-Borst ring to close it com
`and skirt form a closure 48. By rotating the spigot as
`10
`pletely. The membrane-type seal is available without
`sembly on the socket, the spigot 46 will move axially
`solvent-sealing of the membrane-containing cap to the
`toward and away from the flexible O-ring 40 to com
`connector, the external surface of the Tuohy-Borst ring
`press it or relieve the pressure against the seat 38, thus
`providing the seal against flow-by. An undersized cath
`creating a Tuohy-Borst-type valve.
`eter or thin wire can be used even though its outside
`15
`The spigot has a bore 50 which is coaxial with the
`diameter would be smaller than the I.D. of the mem
`main passageway 22 and a bore 51 through the O-ring
`brane, for in this situation, the Tuohy-Borst valve could
`40. At the outer or proximal end of that bore 50 is a
`be tightened. Thus, the full range of catheters and guide
`membrane 55 having a tiny bore 56 of 0.040' to 0.035'
`wires is available with the single connector. There
`diameter which grips the catheter 11 and forms a seal
`never would be a requirement for removal of the con
`with it. The membrane 55 is retained on the closure 48
`nector and reconnecting the manifold to the guide cath
`by means of a cap 57 that is ultrasonically welded to the
`eter as is the case with some procedures using the mem
`spigot assembly to form a leak-tight seal with the spigot
`brane. The need for a precise sealing adjustment as is
`assembly.
`required in the Tuohy-Borst valve is eliminated for all
`The socket 35 has an inwardly-directed collar 60 and
`but the smallest catheters. The possibility of air embo
`25
`the spigot 46 has an outwardly-directed collar or rim 61.
`lism that can occur when the connector is removed and
`When the spigot 46 is inserted into the socket far
`the manifold attached to the guide catheter and vice
`enough to slightly compress the soft ring 40 on the seat
`versa is eliminated.
`38, the collar 61 is in engagement with the collar 60,
`All of the foregoing objects, features and advantages
`thus defining the outer limit of movement of the spigot
`of the invention will become more readily apparent
`with respect to the socket. As long as the spigot goes no
`from the following detailed description taken in con
`farther outward with respect to the socket, the seal
`junction with the accompanying drawings in which:
`against flow-by will always be maintained by the com
`FIG. 1 is a diagrammatic view of the apparatus for
`pression of the ring 40 against the seat 38 and the surface
`performing an angioplasty procedure;
`42.
`FIG. 2 is a cross-sectional view of the Y connector;
`During a procedure, the dilatation catheter 11 passes
`and
`through the main passageway 22, the bore 51 in the
`FIG. 3 is an enlarged fragmentary view of the encir
`O-ring, the bore 50 in the spigot, the bore 56 in the
`cled portion of FIG. 2.
`membrane and out of the proximal end of the Y connec
`Referring to FIG. 1, a guide catheter 10 is inserted,
`tor. The free end of the dilatation catheter is connected
`via a patient's arm or leg 13, into the heart 14 adjacent
`40
`to a supply of a saline mixture by which the balloon 12
`the coronary artery. A dilatation catheter 11 is posi
`in the dilatation catheter is inflated.
`tioned inside the bore of the guide catheter. At the end
`In operation, the guide catheter is connected to the Y
`of the dilatation catheter is a balloon 12 which is inflat
`connector and the manifold with its attachments are
`able by the injection of a saline-based solution.
`attached to the Y connector. The guide catheter is in
`The guide catheter 10 has a hub 15 that is connected
`45
`serted via the patient's arm or leg into the patient's
`to a rotatable coupling 16 of the type disclosed in U.S.
`coronary artery. As it is snaked through that tortuous
`Pat. No. 4,254,773. A Y connector 20 is formed by a
`path, the rotator 16 permits it to twist while the Y con
`clear plastic casing 19 that has a standard male Luer slip
`nector and its attachments remain in a relatively fixed
`21 which is inserted into the end of the rotator coupling
`position.
`16.
`With the guide catheter in place, the contrast medium
`The Y connector has a main passage 22 and a branch
`is inserted through the port 30 and the branch passage
`passage 23. The branch passage terminates in a standard
`way 23. With the contrast medium in the coronary
`female Luer lock 24. A manifold 25 is connected by
`artery, an arteriogram shows the cardiologist the area
`way of the Luer lock to the branch passage 23. The
`of blockage.
`manifold has at least two ports 26 and 27 that are con
`55
`trolled by stopcocks 28. One port, 27, for example, is
`The dilatation catheter is then inserted into the coro
`nary artery with the balloon 12 positioned within the
`connected to a blood pressure monitor of the type de
`area of blockage. Possibly preliminary to the insertion
`scribed in patent application Ser. No. 07/072,909, filed
`July 14, 1987. The manifold has another port 30 which
`of the dilatation catheter, a small guide wire will have to
`is connected to a supply of contract medium that is to be
`be inserted in order to open the blocked artery suffi
`60
`inserted into the coronary artery to provide the contrast
`ciently to permit the introduction of the balloon cathe
`for an arteriogram that is used throughout the proce
`ter. As the dilatation catheter passes through the mem
`dure.
`brane 55, it is sealed with respect to the membrane and
`blood is prevented from exiting the Y connector via the
`The main branch 22 has a socket 35 which is threaded
`as at 36 on its external surface. As seen in FIG. 3, the
`membrane. Blood is also prevented from flowing be
`socket has an internal surface 37 having a tapered valve
`tween the spigot and socket surfaces by the slight com
`seat 38 at one end. A silicon or rubber O-ring 40 is
`pression of the O-ring 40 against the seat 38 and the
`seated at the bottom of the socket against the tapered
`frustoconical surface 45 on the spigot.
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`As long as collar 61 has not moved outwardly past
`a first seal in said main passageway having a circular
`opening therethrough,
`the collar 60, the seal against flow-by at the rubber seal
`means for adjusting the diameter of said opening to
`40 will remain intact.
`Once the dilatation catheter is in place, it is gradually
`any diameter between about 0.050 inch and zero,
`inflated to rupture the placque that is creating the
`and a second elastomeric seal in said main passage
`way having a fixed circular opening having a diam
`blockage of the coronary artery. The catheter is there
`eter in the range of about 0.040 to 0.035 inch,
`after withdrawn. When it is withdrawn, blood will want
`to exit through the membrane 50. However, by turning
`said second seal preventing blood flow by a dilatation
`down the spigot onto the Tuohy-Borst valve, the valve
`catheter inserted in said passageway, said first seal
`being adapted to close said passageway when a
`can be completely closed down, thereby blocking flow
`of blood out of the main passage 22.
`catheter is removed.
`3. A connector as in claim 2 further comprising,
`With the catheter removed, contrast medium is again
`injected and an arteriogram is viewed to determine the
`a closure on said passageway at one end of said cas
`success of the procedure thus far.
`Ing,
`It may be determined that a larger dilatation catheter
`said second seal being mounted on said closure,
`should be inserted. If so, that operation is performed by
`said closure being threaded onto said casing,
`partially inserting the catheter up to the Tuohy-Borst
`a spigot on said closure projecting into passageway
`valve, opening the Tuohy Borst valve and proceeding
`and in contact with said first seal, said spigot being
`operative to close the opening in said seal when
`with the insertion of the catheter. The inflation proce
`dure is repeated.
`moved toward said seal by rotating said closure.
`20
`4. A connector as in claim 3 in which said first seal
`If it is desired to use a catheter or wire smaller than
`provides a seal against flow of fluids between the out
`the 0.040' to 0.035' bore in the membrane 55, the leak
`age can be blocked by the turning down of the Tuohy
`side of said spigot and said casing.
`Borst valve, care being exercised to prevent the crush
`5. A connector as in claim 4 further comprising, de
`ing of the small catheter or imparting such a great fric
`tent means limiting axial movement of said closure and
`25
`spigot away from said first seal whereby to maintain
`tion to it or the wire that it cannot be threaded into the
`pressure of said spigot on said first seal.
`artery.
`From the above disclosure of the general principles
`6. A Y-connector for an angioplasty procedure com
`prising,
`of the present invention and the preceding detailed
`a casing having a bore forming a main passageway for
`description of a preferred embodiment, those skilled in
`a catheter and having a branch passageway inter
`the art will readily comprehend the various modifica
`secting said main passageway,
`tions to which the present invention is susceptible.
`a shoulder forming a seat in said main passageway,
`Therefore, we desire to be limited only by the scope of
`a compressible O-ring on said seat,
`the following claims and equivalents thereof.
`a closure at one end of said passageway and threaded
`We claim:
`35
`on said casing,
`1. A Y-connector for an angioplasty procedure com
`prising,
`a spigot on said closure extending into said passage
`a casing having a bore forming a main passageway for
`way to compress said O-ring against said seat and
`a catheter and having a branch passageway inter
`to prevent fluid flow between the outside of said
`secting the main passageway,
`spigot and said casing,
`a Tuohy-Borst valve in the main passageway,
`said spigot adapted, upon screwing down said clo
`and a membrane disposed in said main passageway,
`sure, to close said O-ring,
`said membrane being coaxial with and spaced from
`a membrane in said closure spaced from and axially
`aligned with said O-ring,
`said Tuohy-Borst valve,
`said membrane having a small hole for receiving a
`said membrane having a circular opening about 0.040
`45
`inch in diameter to receive and seal a catheter,
`dilatation catheter.
`2. A Y-connector for an angioplasty procedure com
`and detent means between said spigot and passage
`prising,
`way to restrict movement of said spigot away from
`a casing having a bore forming a main passageway for
`said O-ring and thus to maintain said O-ring always
`a catheter and having a branch passageway inter
`under some compression.
`secting the main passageway,
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