5,897,497
`[11] Patent Number:
`[19]
`United States Patent
`
`Fernandez
`[45] Date of Patent:
`Apr. 27, 1999
`
`U5005897497A
`
`[54] GUIDING CATHETER INTRODUCER
`ASSEMBLY
`
`[75]
`
`Inventor:
`
`Juan Carlos Fernandez, Miami, Fla.
`
`[73] Assignee: Cordis Corporation, Miami Lakes, Fla.
`
`[21] Appl. No.: 08/508,098
`
`[22]
`
`Filed:
`
`6
`
`Jul. 27, 1995
`
`........................................................ A61B 6/00
`Int. Cl.
`[51]
`.
`............................................. 600/435, 609/280
`[52] US. Cl.
`[58] Field of Search ..................................... 604/280, 281,
`604/282, 283, 164, 165.7, 158; 128/658;
`600/433—434’ 435
`
`56
`
`[
`
`]
`
`C't d
`R f
`l e
`e erences
`US. PATENT DOCUMENTS
`3/1987 B t
`4650472
`5/1987 13:66:61.1;""""""""""""""""""""
`4,665,604
`9/1991 Castillo..
`5’045’072
`11/1991 Hillstead .
`5,066,285
`5,171,232 12/1992 Castillo.
`5,300,032
`4/1994 Hibbs et a1.
`
`.
`
`128/658
`
`5,324,262
`5,389,090
`5,397,310
`
`5,413,561
`5,423,762
`5,514,236
`5,538,512
`5,538,513
`5,558,652
`
`.
`6/1994 Fischell et a1.
`2/1995 Fischell etal..
`3/1995 Chu et a1.
`............................... 604/158
`
`5/1995 Fischell et a1.
`......................... 604/167
`6/1995 Hillstead.
`5/1996 Avellan et a1.
`......................... 156/154
`7/1996 Zenzon et al.
`604/280
`
`7/1996 Okajima .......
`604/280
`9/1996 Henke ..................................... 604/280
`
`Primary Examiner—Max Hindenburg
`Assistant Examiner—Pamela L. Wingood
`AHome ) A em, or Firm—Thomas Vi fl; Henr Collins;
`y
`g
`g
`y
`Dean Garner
`
`ABSTRACT
`[57]
`includes a
`A guiding catheter introducer assembly that
`catheter introducer sheath, With a hemostasis valve, attached
`or molded to a reinforced guiding catheter tubular body into
`a single assembly. The reinforced guiding catheter tubular
`body is made of braided Wire construction. The catheter
`introducer sheath assembly includes a side port at Which
`point a multiport stop cock is attached or molded,
`to
`facilitate the insertion and Withdrawal of fluids.
`
`4 Claims, 3 Drawing Sheets
`
`
`
`Page 1
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`Medtronic Exhibit 1499
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`Page 1
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`Medtronic Exhibit 1499
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`

`

`US. Patent
`
`Apr. 27, 1999
`
`Sheet 1 0f 3
`
`5,897,497
`
`FIG
`
`1
`
`)
`
`(3|
`
`g,#.V.
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`‘18
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`Page 2
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`Medtronic Exhibit 1499
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`Page 2
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`Medtronic Exhibit 1499
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`

`

`US. Patent
`
`Apr. 27, 1999
`
`Sheet 2 0f3
`
`5,897,497
`
`
`
`Page 3
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`Medtronic Exhibit 1499
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`Page 3
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`Medtronic Exhibit 1499
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`

`

`US. Patent
`
`Apr. 27, 1999
`
`Sheet 3 0f3
`
`5,897,497
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`Page 4
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`Medtronic Exhibit 1499
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`Page 4
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`Medtronic Exhibit 1499
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`

`

`5,897,497
`
`1
`GUIDING CATHETER INTRODUCER
`ASSEMBLY
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`The present invention relates to an intravascular guiding
`catheter assembly, for use in the insertion and removal of
`medical devices and/or fluids into a blood vessel of a patient.
`2. Description of the related art including information
`disclosed under 37 CFR §§ 1.97—1.99.
`Heretofore, various guiding and introducer catheters have
`been proposed. Several examples of analogous and non-
`analagous guiding and introducer catheter assemblies are
`disclosed in the following U.S. Pat. Nos:
`
`U.S. Pat. No.
`
`Patentee
`
`5,066,285
`5,300,032
`5,324,262
`5,389,090
`
`Hillstead
`Hibbs et al.
`Fischell et al.
`Fischell et al.
`
`The Hillstead U.S. Pat. No. 5,066,285 discloses a catheter
`introducer with a sheath made of an expanded fibrous
`plastic, for gaining temporary entry into a patient’s blood
`vessel with the use of a dilator. A catheter can subsequently
`be inserted into a patient’s blood vessel after removal of the
`dilator through a hemostasis valve, located at the distal end
`of the catheter introducer sheath. The sheath features flex-
`
`ibility without kinking and high hoop strength.
`The Hibbs et al. U.S. Pat. No. 5,300,032 discloses a
`catheter introducer with a rigid tubular body and a soft
`flexible tubular tip formed from a polymer material, such
`that the tip can navigate a greater curvature of a vessel wall
`without buckling. Attached to the proximal end of the
`tubular body is a valve and seal structure to prevent leakage
`during insertion and placement of the catheter.
`The Fischell et al. U.S. Pat. No. 5,324,262 discloses an
`introducer sheath with an inflatable collar. The inflatable
`
`collar can be expanded to fit snugly against the edges of an
`opening in the blood vessel wall formed by the insertion of
`the introducer sheath to prevent blood leakage through the
`blood vessel wall. At a proximal section of the sheath is a
`proximal fitting containing a hemostasis valve.
`The Fischell et al. U.S. Pat. No. 5,389,090 discloses a
`guiding catheter with an attached Touhy-Borst fitting. The
`guiding catheter uses a dilator and a guide wire to direct the
`catheter to its destination within a patient’s artery without
`requiring an introducer sheath.
`SUMMARY OF THE INVENTION
`
`According to the present invention there is provided a
`guiding catheter introducer assembly that includes a catheter
`introducer sheath, with a hemostasis valve, attached or
`molded to a reinforced guiding catheter tube into a single
`assembly. The reinforced guiding catheter tube comprises a
`braided wire reinforced tubular body. The catheter intro-
`ducer sheath further includes a side port at which point a
`stop cock can be attached or molded, again part of the single
`assembly, to facilitate the insertion and withdrawal of fluids.
`By incorporating a braided wire reinforced guiding cath-
`eter tube into a catheter introducer assembly with a hemo-
`stasis valve attached thereto having a stopcock valve con-
`nected thereto into a single assembly, such assembly allows
`a physician to insert and place the guiding catheter directly
`
`2
`into the body and start inserting medical devices through the
`hemostasis valve with minimal leakage of body fluids. Also
`liquids can be easily inserted into or withdrawn from the
`patient through the stopcock valve.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view of one embodiment of a
`guiding catheter introducer assembly constructed to the
`teachings of the present invention.
`FIG. 2 is an exploded view of the same embodiment
`featured in FIG. 1 with the guiding catheter introducer
`assembly and a stop cock enlarged to show greater detail.
`FIG. 3 is a cross section of one embodiment of a rein-
`
`forced guiding catheter tubular body of the assembly and is
`taken along line 3—3 of FIG. 2.
`FIG. 4 is a cross section of the same reinforced guiding
`catheter tubular body shown in FIG. 3 and is taken along line
`4—4 of FIG. 3.
`
`FIG. 5 is a partially exploded, perspective view of the
`guiding catheter sheath introducer assembly with an end cap
`portion removed and separated from a proximal end of the
`assembly to show a hemostasis valve of the assembly.
`FIG. 6 is an enlarged plan view of the hemostasis valve
`partition.
`FIG. 7 is an elevational view of the same hemostasis valve
`
`partition shown in FIG. 6 and is taken along line 7—7 of
`FIG. 6.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`Referring now to the drawings in greater detail, there is
`illustrated in FIG. 1 a guiding catheter introducer assembly
`10 constructed according to the teachings of the present
`invention. The guiding catheter introducer assembly 10
`includes a catheter sheath introducer body 12 integrally
`attached to a guiding catheter tubular body 14.
`The guiding catheter tubular body 14 (shown in FIGS. 3
`and 4) has a stiff braid reinforced body similar to the catheter
`body described in Dubowik, U.S. Pat. No. 4,665,604 whose
`specification is incorporated herein by reference. A soft tip
`15 is provided and is void of the stiff braid reinforcing.
`Aside port 16 extends laterally outward from the catheter
`sheath introducer body 12. Integrally attached to the side
`port 16 is a multiport stop cock 18 via a tubing 20. The
`interior of tubing 20 couples to side port 16 and allows fluids
`to transfer through the catheter introducer body 12 to the
`guiding catheter tubular body 14 from the side port 16 and
`the multiport stop cock 18.
`At a distal end 22 of the guiding catheter tubular body 14,
`the tip 15 is coated with a radiopaque material such that it
`is visible on an x-ray machine when inserted into the patient.
`A more detailed description of such structure can be found
`in the Castillo et al. U.S. Pat. No. 5,045,072, and the Castillo
`et al. U.S. Pat. No. 5,171,232, whose specifications are
`incorporated herein by reference.
`Referring now to FIG. 2, there is illustrated therein an
`enlarged view of the guiding catheter introducer assembly
`10, highlighting in greater detail the catheter sheath intro-
`ducer body 12 and the multiport stop cock 18.
`The multiport stop cock 18 has two side ports 24 and 26
`and a lever 28 for opening and closing a path between the
`opening at the end of the side ports 24 and 26 and the interior
`of the tubing 20. Additionally, shown attached to side port 24
`is a Luer-lockTM connector 30. The multiport stop cock 18
`
`10
`
`15
`
`20
`
`25
`
`30
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`35
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`40
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`45
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`50
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`55
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`5,897,497
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`3
`allows fluids to be injected and withdrawn simultaneously as
`needed by the user.
`The catheter sheath introducer body 12 has an opening 32
`at the proximal end 33 of the catheter sheath introducer body
`12. The opening 32 allows the user to insert or remove
`medical devices through the guiding catheter introducer
`assembly 10 into and out of the blood vessel and direct them
`to a desired location in the patient’s body.
`Molded to the side of the catheter sheath introducer body
`12 is a rotatable annular flange 34 with an eyelet 36. The
`eyelet 36 can be used as a suture ring allowing the guiding
`catheter introducer assembly 10 to be stitched to the patient
`after the guiding catheter introducer assembly 10 has been
`inserted. This prevents movement of the guiding catheter
`introducer assembly 10 after it is secured in place.
`In FIG. 5 there is illustrated a catheter sheath introducer
`
`body 12 with an end cap portion 38 removed and separated
`from a proximal end 33 of the body 12. Within the catheter
`sheath introducer body 12, normally adjacent to the opening
`32, is a hemostasis valve partition 40. The hemostasis valve
`partition 40 prevents the flow of fluids or gasses through the
`opening 32 when the user inserts or removes a medical
`device, such as an angioplasty balloon assembly into the
`patient through the guiding catheter introducer assembly 10.
`The hemostasis valve partition 40 of the preferred
`embodiment is illustrated in FIG. 6 and FIG. 7. FIG. 6 shows
`
`a plan view of the hemostasis valve partition 40. FIG. 7
`shows an elevational view of the hemostasis valve partition
`40. Through the center of the valve partition 40 are cut slits
`in the form of a plurality of radii 42. As the slits extend into
`the valve partition 40 the radii 42 are rotated in a helical
`manner to a depth 44 between two-thirds to three-quarters of
`the overall thickness of valve partition 40. At which point
`the slits continue to extend at a reduced and diminishing
`diameter 46 until the slits extend the rest of the way through
`the end 48 of the valve partition 40.
`The hemostasis valve partition 40 is preferably made of
`silicone rubber, but a variety of elastomers may also be used.
`Of course, another type of hemostasis valve partition can
`be used in the assembly 10 and still achieve the benefits
`described and inherent in the present invention.
`Because the guiding catheter introducer assembly 10 is
`meant to incorporate the functionality of both an introducer
`sheath and a guiding catheter the length of the guiding
`catheter tubular body 14 of the preferred embodiment of the
`guiding catheter introducer assembly 10 is minimally 80
`centimeters in length, and preferably 100 to 110 centimeters,
`and has a central passageway which has a preferred diameter
`of French 9.
`
`A guiding catheter tubular body 14 with length of
`approximately 100 will be able to reach most locations
`within the heart blood vessels to which a user should wish
`
`to access. A guiding catheter tubular body 14 with a central
`passageway of diameter French 9 will allow access for most
`devices, i.e. balloon catheters, which need to be inserted into
`the blood vessel including an additional guiding catheter.
`Because the catheter sheath introducer body 12 is attached
`directly to the guiding catheter tubular body 14 as a single
`assembly, there is no need for assembly and disassembly of
`the unit for any reason, by the end user. Additionally only a
`single entry into the blood vessel wall is necessary, thereby
`reducing the trauma associated with entry into the blood
`vessel. The user merely inserts and places the guiding
`catheter introducer assembly 10 into position and starts
`inserting medical devices through the opening 32 and hemo-
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`4
`stasis valve partition 40 of the catheter sheath introducer
`body 12, as well as injection of agents or removal of fluids
`through the stop cock 18. When the user has completed the
`desired procedures, the user removes the entire assembly 10
`and closes the blood vessel entry point.
`From the foregoing description, it will be apparent that the
`guiding catheter introducer assembly 10 of the present
`invention has a number of advantages, some of which have
`been described above and others of which are inherent in the
`invention. Also it will be understood that modifications can
`
`be made to the guiding catheter introducer assembly
`described above without departing from the teachings of the
`invention.
`I claim:
`
`1. A guiding catheter and introducer assembly for inser-
`tion into a blood vessel of a patient comprising:
`a catheter sheath introducer body;
`a hemostasis valve attached to said catheter sheath intro-
`
`ducer body and having a distal end, a proximal end and
`a central passageway therethrough opening onto both
`said proximal end and said distal end;
`a guiding catheter tubular body which is flexible and
`resilient, which can be coiled and which has a distal
`end, a proximal end and a central passageway or lumen
`therethrough opening onto both said proximal end and
`said distal end, said guiding catheter tubular body
`including a self supporting wire braided reinforced
`tubular body including an elastomeric polvurethane
`resin, said proximal end of said guiding catheter tubular
`body being integrally attached to said distal end of said
`catheter sheath introducer body as a single unit such
`that said central passageway of said catheter sheath
`introducer body and said central passageway or lumen
`of said guiding catheter tubular body form a common
`continuous passageway which is large enough to
`receive a French 9 catheter;
`said catheter sheath introducer body having a side port
`having a distal end, a proximal end and a central
`passageway therethrough opening onto both said proxi-
`mal end and said distal end, said proximal end of said
`side port being in communication with said opening in
`said central passageway of said catheter sheath intro-
`ducer body;
`a stop cock assembly being integrally attached to the
`distal end of said side port;
`said central passageway or lumen of said guiding catheter
`tubular body being coated or lined with a lubricous
`material to increase the lubricity thereof;
`said guiding catheter tubular body having a radiopaque tip
`at said distal end of said guiding catheter tubular body;
`and,
`said guiding catheter tubular body having a length
`between approximately 80 centimeters and approxi-
`mately 110 centimeters.
`2. The guiding catheter and introducer assembly of claim
`1, wherein said stop cock is a multiport stopcock.
`3. The guiding catheter and introducer assembly of claim
`1, wherein said catheter sheath introducer body further
`comprises a rotatable annular flange.
`4. The guiding catheter and introducer assembly of claim
`3, wherein said flange further comprises an eyelet
`for
`allowing the guiding catheter introducer assembly to be
`sewn to the patient.
`
`Page 6
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`Page 6
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`Medtronic Exhibit 1499
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