(19) Japan Patent Office (JP)
`
`([2) Japanese Unexamined Patent
`Application Publication (A)
`
`(11) Japanese Unexamined Patent
`Application Publication Number
`
`BIO-57497
`(43) Publication date; March 3, 1998
`Technical indications
`
`(51) Int. CL6
`A61M 25/00
`
`Identification codes
`420
`
`JPO file numbers
`
`F1
`A61M 25/00
`
`420H
`
`Request for examination: Not yet requested Number of claims: 4 FD (Total of 5 pages)
`
`(21) Application number
`
`(22) Date of application
`
`Japanese Patent
`Application H8—237227
`August 20, 1996
`
`(71) Applicant
`
`(71) Applicant
`
`(72) Inventor
`
`592148993
`Togo Medikit KKI
`13-2 Yushima 1-chome, Bunkyo-ku, Tokyo-to
`5 94 165 608
`SAWADA, Satoshi
`A-204, 4-58 Shuriishimine—cho, Naha—shi,
`Okinawa-ken
`
`SAWADA, Satoshi
`15-3 Sanbomnatsu 3-chome, Yonago-shi,
`Tottori—ken
`
`
`
`TOIGAMI, Akihiro
`c/o Togo Medikit KIKI Hyuga Plant, 17148-6
`Aza Kamekawa, ()aza Ilichiya, Ilynga-shi,
`Miyagi—ken
`Patent attorney HASHIMOTO, Katsuliiko
`(and 1 other)
`
`
`(72) Inventor
`
`(74) Agent
`
`(54) (Title of the Invention) Puncture needle for catheter introduction
`
`(57) (Abstract)
`(Problem) To eliminate concerns of blood infection of
`technicians, etc. by preventing outflow of blood in the period
`after removing the inner needle While leaving a cannula in
`place and until a guide wire has been introduced, and by
`protecting the tip of the removed inner needle.
`(Means for solving) A cannula hub 4 having a puncture
`confirmation section 18 allowing visual observation of blood
`pulsation from the outside and a hemostasis valve 17 is
`secured to the base end of a cannula 1 to perform puncture
`confirmation and blood outflow prevention when the inner
`needle 21 inserted therethrough is removed. Furthermore,
`when the inner needle 21 has been removed a retaining piece
`36 is engaged With a locking groove 23 in the tip end section
`of the inner needle 21 and a needle tip cover member 31
`encloses the tip end~ allowing disposal Without concerns of
`persons being injured by the puncture blade 22 with blood
`adhering theretoi
`
`
`
`ActiveUS 160131923v11
`
`BD 1118
`BD 1118
`BD v. B. BRAUN
`BB V. B. BRAUN
`IPR2017-01587
`|PR2017-01587
`BBDE0097667
`
`

`

`(Scope of patent claims)
`(Claim 1) A puncture needle for catheter introduction
`characterized in that a cannula hub having a puncture
`confirmation section which allows Visual observation of
`blood pulsation from the outside and a hemostasis valve
`which prevents outflow of blood is secured to the base end of
`a cannula, and an inner needle having an inner needle hub at
`its base end passes tightly through said hemostasis valve and
`is inserted through said cannula hub and cannula.
`(Claim 2) A puncture needle for catheter introduction as
`described in Claim 1, characterized in that an annular locking
`groove is provided on the outer circumference of the tip end
`section of said inner needle, and a needle tip cover element
`which encloses the tip end section of said inner needle and
`has a retaining piece which engages elastically with said
`locking groove is arranged between said cannula hub and
`inner needle hub so as to allow insertion of said inner needle
`(Claim 3) A puncture needle for catheter introduction as
`described in any one of Claims 1 or 2, characterized in that
`said cannula hub has a Wire guidance piece which guides a
`guide wire to the same insertion location in said hemostasis
`valve as that of said inner needle.
`(Claim 4) A puncture needle for catheter introduction as
`described in any one of Claims 1, 2 or 3, wherein said
`puncture confirmation section has a configuration comprising
`a narrow diameter blood inflow channel through which said
`inner needle passes; an air trap chamber which constitutes the
`base end of the puncture confirmation section and is disposed
`on the tip end side of said hemostasis valve, and a ventilation
`hole, which has a filter that does not allow blood to pass
`through but allows air to pass through, and which places said
`blood inflow channel in communication with the atmosphere
`(Detailed description of the invention)
`(0001)
`(Technical field of the invention) The present invention
`relates to a puncture needle used for introducing a catheter
`into a blood vessel for purpose of diagnosis or treatment of
`blood vessels or organs.
`(0002)
`(Prior art) The operation of introducing a catheter into a
`blood vessel
`is in many cases based upon the steps as
`described schematically for example in Japanese Examined
`Patent Application Pub ication H2-949, whereby,
`first, a
`blood vessels is punctured percutaneously with a puncture
`needle comprising an inner needle inserted through a
`cannula; second, the inner needle is removed while leaving
`the cannula in place; thi d, a guide wire is inserted through
`the cannula and introduced into the blood vessel; fourth, the
`cannula is removed Whi e leaving the guide wire in place;
`fifth, an introducer (catheter introducer) comprising a dilator
`tube inserted into a shea h is fitted onto the guide wire and
`introduced into the blood vessel; sixth, the guide wire and
`dilator tube are removed while leaving the sheath in place;
`and seventh, the catheter is inserted through the sheath and
`brought to the target loca ion inside the blood vessel,
`(0003)
`(Problem to be solved by the invention) In the fifth, sixth
`and seventh steps of
`the catheter
`insertion operation
`described above,
`the introducer has a valve element at the
`base of the sheath, and when the dilator tube and catheter are
`inserted, the valve element tightly contacts these, and during
`the seventh and eighth steps, the valve element closes due to
`its own elastic force,
`thereby allowing the operations to be
`performed without outflow of blood,
`
`
`
`ActiveUS 160131923v, 1
`
`Japanese Unexamined Patent Application Publication HID-57497
`
`(0004) However, between the second step and third step,
`ie after removing the inner needle and until the guide wire is
`inserted, it is not possible to prevent blood from flowing out
`from the cannula,
`in this case, even if the technician takes
`care to quickly insert the guide wire and keep the outflow of
`blood to a minimum, in cases where an artery is punctured, a
`quite large volume of blood will end up flowing out.
`(0005) Depending on the patient, the blood which flows
`out through the cannula may contain infectious bacteria and
`viruses and may be extremely dangerous, so it is necessary to
`proceed to the next operation while being very careful to
`avoid contact with the blood, and thus there is the concern of
`slipping up
`and committing
`an error
`in
`operation
`Furthermore, wiping up blood which has flowed out provides
`many opportunities
`for contact and is
`thus extremely
`dangerous,
`(0006) Moreover, blood adheres to the tip end section of
`the inner needle removed from the cannula in the second step,
`Even though the sharp tip end section can especially easily
`injure persons, there is no means of disposing of it in a safe
`state which poses no concern of injury, and thus careful
`attention must be paid during handling.
`(0007) It is an object of the present invention, first, with
`regard to the cannula of the puncture needle, to resolve he
`aforementioned problem of not being able to prevent blood
`from flowing out to the outside in the period after removing
`the inner needle until the guide wire is inserted, and seco ad,
`in addition to the above, with respect to the removed inter
`needle,
`to resolve the other aforementioned problem of he
`concern of persons being injured because the tip end section
`with adhered blood is in an exposed state,
`(0008)
`he
`resolve
`the problem) To
`solving
`for
`(Means
`aforementioned problems, in the present invention, a cannula
`hub having a puncture confirmation section which allows
`pulsation of blood to be viewed from the outside anc a
`hemostasis valve which prevents outflow of blood is secured
`to the base end of a cannula, and an inner needle having an
`inner needle hub at its base end is passed tightly through he
`hemostasis valve and inserted through the cannula hub and
`cannula.
`is punctured and
`(0009) Namely, when a blood vessel
`penetrated and the inner needle is removed and then he
`cannula is slightly retracted, the fact that the tip end has been
`positioned inside the blood vessel is confirmed based on he
`fact that blood flows into the puncture confirmation section
`through the cannula, and outflow of blood to the outside is
`prevented by the hemostasis valve, Therefore, this completely
`prevents the outflow of blood, which could not be avoided in
`the conventional technique of attaching a syringe to the inner
`needle hub and confirming that the blood vessel has been
`correctly punctured based on the inflow of blood into the
`syringe, thus resolving the first problem described above,
`(0010) Furthermore, in the present invention, in addition to
`the above, an annular locking groove is provided on the outer
`circumference of the tip end section of the inner needle, and a
`needle tip cover element which has a retaining piece that
`engages elastically with the locking groove and which
`encloses the tip end section of the inner needle is arranged
`between the cannula hub and inner needle hub so as to allow
`insertion of the inner needle.
`(0011) Namely, when the inner needle has been removed
`from the cannula and cannula hub,
`the tip end section is
`enclosed by the needle tip cover element and the retaining
`
`
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`BBDE0097668
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`

`

`piece elastically fits into and engages with the locking groove,
`so that the tip end section with adhered blood assumes a state
`where it
`is enclosed by the needle tip cover element,
`Therefore, disposal can be performed safely Without concern
`of persons being injured by the needle tip, thereby resolving
`the second problem described above
`(0012) Moreover, in the present invention, in addition to
`the above, a wire guidance piece which guides the guide wire
`to the same insertion location in the hemostasis valve as that
`of the inner needle is provided in the cannula huh,
`(0013) As a result, guide wires with a tip end curved in a
`hook shape deform into a linear shape and are guided into the
`blood
`vessel while
`proceeding
`straight
`through
`the
`hemostasis valve, puncture confirmation section and cannula,
`allowing guide wires with various tip end shapes to be
`accommodated.
`(0014)
`(Modes of embodiment of the invention) To describe a
`mode of embodiment of the present invention while referring
`to the drawings, the cannula 1 is made of synthetic resin, and
`has a well known shape and structure comprising a flexible
`thin tube 2 and a hard connecting part 3 of enlarged diameter
`at the base end, Cannula hub 4 is made of transparent hard
`synthetic resin and comprises a front hub element 5 and rear
`hub element 6, whereby fitting and fixing the connecting part
`3 to a reduced diameter attachment part 7 on the tip end
`section of the front hub element 5 causes the cannula 1 and
`cannula hub 4 to be secured to each other and extend in a
`straight line
`(0015) The front hub element 5 comprises an air trap
`chamber 8 open on the base end surface; a narrow diameter
`blood inflow Chamiel 9 which communicates with the air trap
`chamber 8 through the tip end surface and forms a puncture
`confirmation section 18; a ventilation hole 10 which extends
`radially from the middle of the blood inflow channel 9 and
`opens on the outer circumferential surface; and a filter 11
`which is secured so as to block the ventilation hole 10 and
`allows air to pass through while not allowing blood to pass
`through,
`(0016) The rear hub element 6 comprises an attachment
`hole 12 which opens on the tip end surface; a tapered
`coupling hole 13 which opens on the base end surface; a wire
`guidance piece 14 which is secured by fitting into attachment
`hole 12; and a hemostasis valve 17 secured over the tip end
`surface of the wire guidance piece, whereby fitting and
`securing the based end of the front hub element 5 into the tip
`end of the rear hub element 6 causes these to be integrally
`joined, thereby forming a cannula hub 4,
`flared
`a
`14 has
`(0017) The wire guidance piece
`introduction hole 15 on the base end side and a narrow
`diameter straight hole 16 on the tip end side, and is made of
`an elastic material, preferably synthetic rubber or natural
`rubber. Furthermore, the hemostasis valve 17 has a disc shape
`with a through—hole in the center or a radial slit, and is made
`of a soft elastic material, preferably synthetic rubber or
`natural rubber, and closes the through-hole or slit by its own
`elastic force, This sort of hemostatic valve 17 is the same as
`those used in catheter introducers, and in the present mode of
`embodiment,
`it seals the base end surface of the air trap
`chamber 8,
`(0018) Next, the inner needle 21 is made slightly longer
`than the assembly of cannula 1 and cannula hub 4, and an
`annular locking groove 23, whereof the base end side is made
`sloped and the tip end side is made as a stepped part
`orthogonal
`to the central axis,
`is provided in the tip end
`section near the puncture blade 22 at the tip end of the inner
`
`ActiveUS 160131923v, 1
`
`(3)
`
`Japanese Unexamined Patent Application Publication PHD-57497
`
`the inner needle hub 24 fixed to the
`needle. Furthermore,
`base end of the inner needle 21 has a tubular cap 25 fitted and
`secured to its base end part, in which a filter 26 is installed,
`which allows air to pass through while not allowing blood to
`pass through,
`(0019) Moreover, a needle tip cover element 31 is arranged
`between the cannula hub 4 and inner needle hub 24. This
`needle tip cover element 31 is made of hard synthetic resin,
`and comprises
`a tapered coupling protrusion 32 which
`matches the coupling hole 13; a small diameter protective
`tube 33 which extends forward; a through—hole 34 formed
`through these and extending over the central axis; and a large
`diameter recess 35 which opens on the base end surface, It
`furthermore has an outward facing flange 38 at the base end
`of tube section 37 with an outside diameter equal to the inside
`diameter of the recess 35, and a retaining piece 36 made of
`thin-walled metal or
`synthetic resin having an annular
`engagement edge 39 with a diameter slightly smaller than the
`outside diameter of the inner needle 21 at its tip end is
`secured by fitting into the recess 35 from the base end side,
`(0020) 1'10.
`1 is a drawing in which the above-described
`assembly of cannula 1 and cannula hub 4, the assembly of
`inner needle 21 and inner needle hub 24 and the needle tip
`cover element 31 have been assembled, wherein the needle
`tip cover element 31 is removably connected to the cannula
`hub 4 in a state where the coupling protrusion 32 is fitted into
`coupling hole 13 and protective tube 33 is inserted through
`the wire guidance piece 14 and hemostasis valve 17, and the
`hemostasis valve 17 tightly contacts the outer circumferential
`surface of the protective tithe 33, Furthermore,
`the inner
`needle 21 pushes open the engagement edge 39, passes
`through the retaining piece 36 and is
`inserted into the
`through—hole 34, and is then inserted through the air trap
`chamber 8, blood inflow channel 9 and capillary tube 2, and
`the puncture blade 22 is exposed at the tip end of the cannula
`1 in a state where the inner needle hub 24 touches the needle
`tip cover element 31,
`(0021) The puncture needle of the present mode of
`embodiment configured in this manner is used to puncture a
`blood vessel percutaneously by the same technique as
`conventional puncture needles, and the inner needle 21 is
`removed once the tip end of the cannula 1 has penetrated
`transversely through the blood vessel,
`(0022) When the inner needle 21 has been withdrawn to
`where the puncture blade 22 has been fully retracted into the
`through-hole 34 and the locking groove 23 comes to a
`position overlapping the engagement edge 39 of the retaining
`piece 36, the engagement edge 39 is restored in the diameter
`reduction direction by its own elastic force and fits into and
`engages with the locking groove 23, As the inner needle 21 is
`withdrawn further, the needle tip cover element 31, which is
`held on the inner needle 21 by the retaining piece 36 so as to
`be immovable in the tip end direction, is removed integrally
`therewith from the cannula hub 4, The hemostasis valve 17
`closes under its own elastic force when the protective tube 33
`is Withdrawn,
`(0023) Next, when the cannula 1 is slightly retracted and
`the tip end of the capillary tube 2 is positioned inside the
`blood vessel, blood flows into the blood inflow channel 9
`through the capillary tube 2, At
`this time, air from the
`cannula l and blood inflow channel 9 passes through the
`filter 11 and is discharged into the atmosphere through the
`ventilation hole 10, so the blood flows in to near the air trap
`chamber 8, and blood inside the blood inflow channel 9
`moves in reciprocating fashion according to the pulsation of
`the vein or artery, This pulsation of the blood can be visually
`
`BBDE0097669
`
`

`

`(4)
`
`Japanese Unexamined Patent Application Publication PHD-57497
`
`invention) According to the present
`the
`(Effect of
`invention, as described above, there is no outflow of blood in
`the period from removal of the inner needle until introduction
`of the guide wire, thus allowing operations to be performed
`without coming into contact with blood which may be
`infected; furthermore, proper insertion of the cannula into the
`blood vessel can be easily confirmed, allowing the operation
`of introducing the puncture needle to be performed safely and
`easily,
`(0030) In addition, according to the present invention, the
`removed inner needle can be safely disposed without
`concerns of being injured by the needle tip, and guide wires
`of various tip end shapes can be reliably introduced,
`(Brief description of the drawings)
`(FIG, 1) A longitudinal cross-sectional View showing a
`mode of embodiment of the present invention,
`(FIG, 2) Illustrates the state where the inner needle has
`been removed,
`(A) being an enlarged longitudinal cross—
`sectional View of the cannula hub and (B) being an enlarged
`longitudinal cross-sectional View of the inner needle tip end
`section.
`(Description of reference symbols)
`cannula; 4 cannula hub; 8
`air trap chamber; 9 blood
`1
`infiow channel; 10
`ventilation hole; 11
`filter; 14 wire
`guidance piece;
`17
`hemostasis valve;
`18
`puncture
`confirmation section; 21 inner needle; 23 locking groove; 24
`inner needle hub; 31 needle tip cover element; 36 retaining
`plece,
`
`confirmed from outside the front hub element 5, which is
`made of transparent material, Furthermore, the present mode
`of embodiment comprises an air trap chamber 8, and the air
`inside this part acts as a cushion, causing the reciprocating
`movement of the blood inside the narrow diameter blood
`inflow channel
`9
`to occur
`in amplified fashion in
`synchronization with the pulsation of the blood vessel, so that
`it can be confirmed easily and accurately,
`(0024) Once the cannula 1 has been installed with its tip
`end positioned inside the blood vessel,
`the guide Wire is
`introduced into the blood vessel through the coupling hole 13
`of the cannula hub 4 and via the wire guidance piece 14;
`hemostasis valve 17, air trap chamber 8, blood inflow
`channel 9 and cannula 1. Once the guide wire has been
`brought to the prescribed location, the assembly of cannula 1
`and cannula hub 4 is removed along the guide wire, a catheter
`introducer is introduced, its sheath is left in place and the
`dilator tube and guide Wire are removed, and then the catheter
`is introduced, In this way, the catheter is brought to the target
`location inside the blood vessel by the same technique as in
`the prior art.
`a
`(0025) The invention described in Claim 1 has
`configuration not comprising the Wire introduction piece 14,
`locking groove 23 and needle tip cover element 31 of the
`mode of embodiment described above, Based on this
`configuration, the fact that the cannula 1 has been positioned
`inside a blood vessel can be visually confirmed by means of
`the puncture confirmation section 18 of the cannula hub 4,
`and outflow of blood is prevented by means of the hemostasis
`valve l7,
`thus allowing the technician to operate safely
`without concerns of infection,
`(0026) Next,
`the invention described in Claim 2 has a
`configuration not comprising the wire guidance piece 14 of
`the mode of embodiment described above, Based on this
`configuration,
`in addition to the effects described above,
`when the inner needle 21 has been withdrawn, the tip end
`section thereof is enclosed by the needle tip cover element 31
`and the cannula 1 and cannula hub 4 are removed in a state
`
`where the puncture blade 22 with adhered blood is not
`exposed, allowing disposal to be carried out safely without
`concerns of persons being injured and infected.
`(0027) It will be noted that even if the needle tip cover
`element 31 has no protective tube 33, the object of disposing
`in a state where the puncture blade 22 is not exposed can be
`achieved by positioning the puncture blade 22 inside the
`coupling protrusion 32 and locking it to the inner needle 21;
`but if a protective tube 33 is provided, concerns of damaging
`the hemostasis valve
`17 and compromising its closing
`function when introducing the inner needle 21 are eliminated,
`(0028) Moreover, the invention described in claim 3 has a
`configuration not comprising the locking groove 23 and
`needle tip cover element 31 of the mode of embodiment
`described above, or a configuration comprising these, Based
`on this configuration,
`in addition to the effects described
`above, the guide wire is guided by the Wire guidance piece 14
`to the center of the hemostasis valve l7, ie to the same
`insertion location as that of the inner needle 21, so that even a
`guide wire with a tip end section curved in a hook shape will
`be deformed into a linear shape and made to travel straight as
`it passes
`through the hemostasis valve
`17, puncture
`confirmation section 18 and cannula 1, allowing guide wires
`with various tip end shapes
`to be accommodated and
`preventing them from passing through locations other than
`the center of the hemostasis valve 17 and thereby damaging
`its function
`(0029)
`
`ActiveUS 160131923V, 1
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`BBDE0097670
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`City of New York}, State of New York, County of New York
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`1, Angela Lo, hereby certify that the document “JP 100574971] 58763] ll)w(l)“ is? to the
`
`best of my knowledge and belief, a true and accurate translation from Japanese into
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`English.
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`2
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