United States Patent to
`Stevens
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`11
`45)
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`4,000,739
`Jan. 4, 1977
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`54 HEMOSTASIS CANNULA
`75 Inventor: Robert C. Stevens, Miami, Fla.
`73) Assignee: Cordis Corporation, Miami, Fla.
`22 Filed:
`July 9, 1975
`21
`Appl. No.: 594,521
`52) U.S. Cl. ............................. 128/214.4; 128/2 A
`(51) Int. Cl.’.......................................... A61M 5700
`58 Field of Search ............... 128/214.4, 221, 272,
`128/2 F, 2 A
`
`56)
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`2,022,369
`3,459, 183
`3,585,996
`3,659,587
`3,825,001
`
`References Cited
`UNITED STATES PATENTS
`1 1/1935 Curtis ................................ 128/272
`8/1969 Ring et al. ...................... 28/214.4
`6/1971
`Reynolds ........................ 128/24.4
`5/1972 Baldwin ............................. 12812 F
`7/974 Bennet et al. .................. 128/214.4
`
`FOREIGN PATENTS OR APPLICATIONS
`430,890
`10/1911
`France ............................... 128/221
`Primary Examiner-Dalton L. Truluck
`Attorney, Agent, or Firm-Kenway & Jenney
`57
`ABSTRACT
`Hemostasis cannula comprising a body having a pas
`sage therethrough adapted to receive a catheter and a
`pair of juxtaposed gaskets mounted in the passage. The
`first gasket forms a seal around a catheter enclosed
`within the cannula; the second gasket is compressed
`against the first to seal the passage when the catheter is
`removed. The cannula also features a flexible entrance
`tube and a port for introducing fluids into a patient's
`blood vessel.
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`4 Claims, 4 Drawing Figures
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`Medtronic Exhibit 1465
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`U.S. Patent Jan. 4, 1977
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`Medtronic Exhibit 1465
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`U.S. Patent
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`Jan. 4, 1977
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`Sheet 2 of 2
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`4,000,739
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`Page 3
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`Medtronic Exhibit 1465
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`1.
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`is to provide means by which the cannula body and
`tubing can be flushed at all times to prevent clotting
`HEMOSTASS CANNULA
`within the cannula or at the interface of the cannula
`BACKGROUND OF THE INVENTION
`and catheter. Catheter insertion is simply accomplished
`by the use of a disposable guide and dilator unit. A
`This invention relates to cannulas, especially those
`flexible tube provides communication through the wall
`used for positioning and manipulating intravascular
`of the artery, hence reducing the danger of unwanted
`catheters known as angiographic catheters.
`puncturing of the wall. It also eliminates the possibility,
`Angiography is a well-known and very valuable pro
`such as that present when a sharp hollow needle is used
`cedure used to diagnose vascular and organ disease. It
`as a cannula, of cutting off pieces of catheter during its
`involves the introduction of a hollow tubular catheter
`into one of the major arteries or veins, such as the
`withdrawal.
`In general, the invention features a hemostasis can
`femoral or brachial arteries, and advancing and maneu
`nula comprising a body having a passage therethrough
`vering it into smaller branching vessels which are to be
`adapted to receive a catheter and having a pair of juxta
`studied. After the catheter is in position, a radio
`posed gaskets mounted in the passage in contact with
`opaque fluid is injected through the catheter into the
`each other. One of the gaskets has a round hole, the
`vascular system to be studied and an x-ray picture is
`other a Y-shaped slit. The first gasket maintains a seal
`taken of the now X-ray opaque vascular structure.
`ing relationship with the catheter and, upon withdrawal
`Prior art techniques for introducing such catheters
`of the catheter from the passage, the gaskets cooperate
`include what is known as the "cut down' method and
`to close the passage, since the gasket with the slit is
`various modifications of the "Seldinger' technique.
`compressed against the first gasket. In preferred em
`The "cut down" technique involves surgically opening
`a vein or artery and introducing the angiographic cath
`bodiments, the cannula further includes a length of
`flexible tubing in fluid tight engagement with the body.
`eter directly through the incision. This method inevita
`A port communicating with the body of the cannula for
`bly involves the loss of blood through the incision as
`introducing fluids into the patient's artery is also pro
`well as venous ligation and arterial repair. The use of
`25
`this method renders it particularly difficult to employ
`vided.
`Other advantages and features will be apparent to
`the same vessel when multiple studies are indicated.
`those skilled in the art from the following description of
`The American Journal of Cardiology, Vol. 30, Sept.,
`a preferred embodiment of the invention and from the
`1972, at page 378, describes an alternative method of
`drawings wherein:
`cardiac catheterization, a modification of the Seldinger
`30
`FIG. 1 is an exploded, partially cut-away view of an
`technique, wherein a percutaneous sheath is intro
`embodiment of the invention;
`duced into the lumen of a blood vessel. A hollow nee
`FIG. 2 is a view in cross-section of the embodiment of
`dle is inserted through the skin and into the lumen; a
`FIG. 1 with a catheter enclosed in the cannula;
`guide wire is passed through the needle and advanced
`FIG. 3 is a view in side elevation of the cannula en
`up the artery or vein into the organ to be studied; the
`closing a dilator unit and guide;
`needle is removed, leaving the guide wire in the vessel;
`FIG. 4 shows the embodiment of FIG. 1 in position in
`a sheath and dilator unit are advanced over the wire
`the lumen of a blood vessel with a catheter enclosed
`into the vessel, and; the dilator is removed along with
`therein.
`the guide wire. Now, any type of catheter desired of
`similar diameter, can be inserted through the sheath
`DESCRIPTION OF A PREFERRED EMBODIMENT
`40
`into the vessel. To avoid excessive bleeding, and to
`As seen in FIG. 1, the cannula comprises a generally
`ensure against the possibility of an air embolism, this
`cylindrical hub or body portion 10 having a snap-on
`technique requires the physician to occlude the orifice
`cap 12 and a tapered portion 13 leading to a length of
`of the sheath during catheter changes. The procedure
`flexible tubing 18. Within the body 10, is a passage
`suffers from the possibility of a blood clot migrating to
`generally designated by arrow 14. The body portion 10
`the heart, lungs, or extremities. Blood loss through the
`and the entrance tube 18 may be conveniently made of
`annular space between the sheath and the catheter is
`any one of a number of well-known suitable plastic
`difficult to avoid.
`materials, e.g., high density polyethylene. A pair of
`Both these methods are also characterized, especially
`gaskets 22, 24 are enclosed within cap 12. The annular
`if multiple studies are indicated, by venous thrombosis,
`gasket 22 has a centrally positioned hole 26 and is
`subcutaneous hematomas, and other considerable dis
`made of latex, silicon rubber, or other suitable sealing
`comfort to the patient. Obviously, neither of these
`material. The hole 26 has a diameter slightly less than
`methods is totally satisfactory.
`that of catheter 46, used with the cannula, so that,
`SUMMARY OF THE INVENTION
`when catheter 46 is inserted through the passage 14,
`55
`the gasket 22 will sealingly engage it, as shown in FIG.
`It is therefore an object of this invention to provide a
`2. The self-sealing gasket 24 has a Y-slit 28 centrally
`cannula which can be left in the vessel during angio
`disposed therein. The slit permits relatively unob
`graphic or other catherterization while the catheter is
`structed passage of the catheter 46 therethrough, yet,
`manipulated within the cannula and vessel. When the
`when catheter 46 is not in position within the cannula,
`catheter is in place there is no blood loss, yet restriction
`the slit closes, rests against the gasket 22, and with
`of catheter manipulation is minimized. A seal capable
`stands a minimum of 300 mm blood pressure, thereby
`of withstanding a minimum blood pressure of 300 mm,
`preventing any blood flow back through the passage
`when the catheter has been removed, is also provided,
`14. The cap 12 has a centrally located hole 16, posi
`thus obviating the necessity of occluding the cannula
`tioned co-axially with the gaskets 22, 24, and an annu
`and preventing significant blood loss at all times. An
`65
`lar ridge 32 which seals the gasket 22 against the cap
`other object of the invention is to provide a cannula
`12. A second annular ridge 30, disposed on body 10,
`having a minimum area of stagnation within the can
`likewise acts to seal the gasket 24.
`nula body portion. Still another object of the invention
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`photograph is taken of the now radio-opaque vascular
`Formed integrally with the body 10 is a boss 34 ex
`system of the organ being studied.
`tending laterally outwardly from the body 10 and con
`If multiple studies are indicated, or if the catheter has
`taining a passage 20 leading into the passage 14. The
`not been positioned correctly, it is a simple matter to
`boss 34 is stepped on its exterior to provide means for
`remove the catheter and introduce another. A guide
`connection to a plastic tube 36 (FIGS. 3 and 4). A
`wire may be used if appropriate. Since, on removal of
`liquid may be introduced through the tube 36 for flush
`the cather 46, the gaskets 22 and 24 close together to
`ing the interior of the cannula hub portion and cannula
`reseal the entrance hole 16, no bleeding is experienced
`tubing, thus helping prevent clotting within the cannula
`by the patient. If desired, with the catheter removed,
`or at the interface of the cannula and catheter in the
`other fluids, such as anesthetic or intravenous feeding
`patient's vessel.
`solution, may be introduced into the vessel through
`So that blood will not flow through the flushing port
`tube 36. Either a closed or opened end catheter may be
`20, the physician will maintain positive pressure of
`conveniently inserted through the cannula of the inven
`flushing fluid throughout the operation.
`tion.
`As seen in FIG. 3, a hollow plastic dilator 42 having
`The invention may be embodied in other specific
`a diameter substantially equal to that of the catheter 46
`forms without departing from the spirit or essential
`may be positioned in passage 14 with its tapered end 45
`characteristics thereof. The present embodiment is
`extending beyond the distal end of the tube 18. After
`therefore to be considered in all respects as illustrative
`the cannula has been inserted in the vessel over guide
`and not restrictive, the scope of the invention being
`43, the dilator and guide may be removed and dis
`indicated by the appended claims rather than by the
`carded.
`foregoing description, and all changes which come
`In operation, an incision 41 is made in the patient's
`within the meaning and range of equivalency of the
`skin close to the vessel to be used, and a hemostat is
`claims are therefore intended to be embraced therein.
`introduced into the incision and maneuvered through
`: What is claimed is:
`the tissue until the vessel is exposed. A hollow needle
`1. A hemostasis cannula comprising a body having a
`25
`into which a solid, sharp-ended trocar has been in
`passage therethrough adapted to receive a catheter, a
`first disc-like gasket having a round hole disposed
`serted (not shown) is then introduced into the vessel.
`therein mounted in said passage, and a second disc-like
`When the lumen 40 of the vessel has been penetrated,
`gasket having a Y-slit located therein, said second gas
`the trocar is removed and replaced by a guide 43, then
`ket being mounted in said passage in face-to-face
`the needle is removed. The hollow plastic dilator 42 is
`contact with said first gasket, said first gasket being
`now threaded through passage 14 of the cannula, as
`operable to maintain a seal around and to allow manip
`shown in FIG. 3, and slipped over the guide 43. The
`ulation of a catheter contained in said passage, the
`physician then dilates the hole through the vessel wall
`face-to-face relationship of said gaskets serving to sup
`by maneuvering the tapered end 45 of the dilator 42
`port said second gasket in its closed position when a
`therethrough and introduces the entrance tube 18 into
`catheter is absent from said passage.
`the vessel lumen 40. Now the cannula is taped in posi
`2. The cannula of claim 1 further comprising a length
`tion on the body of the patient, and, with the feed
`of flexible tubing in fluid-tight engagement with said
`tubing 36 fastened to the connector 34 and while main
`body.
`taining a slow flow of heparin saline solution, the physi
`3. The cannula of claim 1 further comprising a port
`40
`cian withdraws the dilator 42 and guide 43. At this
`communicating with said passage for introducing fluids
`point, the slit 28 in the gasket 24 closes and, with the
`into a patient's blood vessel.
`support of adjacent gasket 22, resists the force exerted
`4. A hemostasis cannula comprising
`by the patient's blood pressure and prevents any blood
`a body having a passage therethrough adapted to
`loss. The catheter is now introduced through the hole
`receive a catheter,
`16 and passes through the gaskets 22 and 24; it is
`first and second disc-like gaskets mounted in said
`guided through hub 10 and into tube 18 by the tapered
`passage in face-to-face contact, said first gasket
`portion 13. It finally passes into the lumen 40 of the
`having a hole disposed therein, and said second
`blood vessel (FIG. 4). As seen in FIG. 2, the slit 28 of
`gasket having a slit therein;
`the gasket 24 opens to allow passage of the catheter;
`a length of flexible tubing in fluid-tight engagement
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`the annular gasket 22 forms a seal around the exterior
`with said body; and,
`of the catheter 46, thereby preventing any blood loss
`a port communicating with said body for introducing
`through the entrance hole 16. The gasket 24 yields
`fluids into a patient's blood vessel, said first gasket
`easily to the catheter and does not inhibit its manipula
`being operable to maintain a sealing relationship
`tion. The annular space 48 (FIG. 2) between the cathe
`with a catheter contained in said passage and, when
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`ter. 46 and the entrance tube 18 is constantly flushed by
`a catheter is not contained in said passage, said
`a flow of heparin saline solution introduced through the
`gaskets being operable to cooperate to close said
`port 20 and the tubing 36 to prevent clotting. When the
`passage, said second gasket being compressed
`against the first to close both the slit and the hole.
`catheter 46 has been maneuvered into position, radio
`opaque fluid is injected therethrough, and an X-ray
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