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Japan Patent Office
`
`Published Utility Model Gazette
`
`Published Utility Model No.
`
`S62-5172
`
`Publication Date:
`
`February 5, 1987
`
`Int.Cl.4:
`
`A61M 1/14, 1/36, G01L 7/00
`
`Identifying Mark:
`
`JPO File Number:
`
`7720-4C, 7720-4C, 7507-2F
`
`(4 pages in total)
`
`Title of the Device:
`
`
`PRESSURE DETECTOR FOR
`BODY-LIQUID PROCESSING CIRCUIT
`
`Utility Model Application No.:
`
`S56-99643
`
`Filing Date:
`
`July 3, 1981
`
`Laying-Open No.:
`
`S58-5443
`
`Laying-Open Date:
`
`January 13, 1983
`
`Inventor:
`
`
`Inventor:
`
`
`Taizo KIRITA
`1-2-1-604, Kitamidorigaoka
`Toyonaka-shi
`Masaru KAWAHASHI
`5-3, Besshiyonakano-cho,
`
`1
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`
`Inventor:
`
`Inventor:
`
`Inventor:
`
`
`Applicant:
`
`
`
`Applicant:
`
`
`
`
`
`Agent:
`
`Examiner
`
`Takatuki-shi
`Kagemoto KARYU
`305, Oaza Ikeda, Saeki-shi
`Kimihisa SUNAHARA
`11843-3, Saeki-shi
`Hidemune NAITO
`13-17, Sumiyoshidai,
`Higashinada-ku, Kobe-shi
`Kabushiki Kaisha Kuraray
`
`1621, Sakazu, Kurashiki-shi
`
`Kawasumi Laboratories, Inc.
`
`7-15, Rokugo 2-chome,
`
`Ota-ku, Tokyo
`
`Patent Attorney Ken HONDA
`
`Takashi TUNO
`
`Reference Document
`
`Utility Model Application No.
`
`
`
`S57-169336
`
`2
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`Scope of Claim for Utility Model Registration
`
`A pressure detector for a body-liquid processing circuit,
`the pressure detector being installed in a body-liquid processing
`circuit and adapted to detect a pressure of a body liquid
`circulating through the circuit, the pressure detector
`comprising: a body-liquid circulation pipe 16 adapted to expand
`and contract by the pressure of the body liquid, the body-liquid
`circulation pipe being configured such that a body-liquid inflow
`pipe 13 is liquid-tightly attached to one of both ends of a pouched
`body formed by two flexible sheets 11 and 15 while a body-liquid
`outflow pipe 14 is liquid-tightly attached to the other thereof,
`and that a filter 12 for body-liquid filtration is disposed to
`separate an inside of the pouched body into a body-liquid inflow
`side and a body-liquid outflow side; an outer pipe 17 formed of
`non-flexible material and adapted to liquid-tightly accommodate
`therein the body-liquid circulation pipe 16, thereby forming a
`sealed chamber with a fluid charged thereinto between the
`non-flexible outer pipe and the flexible body-liquid circulation
`pipe; and a pressure gauge 20 attached to an end of a conduit 19
`connected to the sealed chamber, wherein the pressure detector
`is configured to detect a pressure of the fluid charged into the
`sealed chamber, as the pressure of the body liquid flowing through
`the body-liquid circulation pipe.
`
`Detailed Description of the Device
`
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`The present utility model relates to a pressure
`[0001]
`detector for a body-liquid processing circuit.
`[0002]
`Conventionally, for example, in hemodialysis or
`ascites filtration condensation, extracorporeal-circulation and
`extracorporeal-processing are performed in which a body liquid
`of a patient is taken out of the body to be processed there and
`then returned again to the body. An extracorporeal circulation
`flow path is provided with not only a tube serving as a circuit
`for the body liquid, but also a pressure detector, a pressure
`adjuster, a bubble removal device, a filtering device, a sampling
`device, a chemical addition device, and the like, as appropriate.
`Among these devices, the pressure detector uses air in an air
`reservoir provided in a drip chamber for removing bubbles to
`operate a pressure gauge. Such a conventional pressure detector
`is illustrated in Fig. 1.
`[0003]
`Referring to Fig. 1, a tube 1 is coupled to an outer
`pipe 2 and has an air reservoir 3 formed at its upper part. A
`body liquid is retained downward of the tube body as indicated
`by reference character 4. This mechanism is normally called a
`drip chamber or an air trap (hereinafter referred to as a drip
`chamber). While the body liquid is retained in the outer pipe
`2, the bubbles rise toward the upper part of the pipe to be
`separated from the body liquid, so that the body liquid without
`any bubbles can be obtained. The outer pipe 2 is provided with
`a conduit 6 for connection between the air reservoir 3 and a
`
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`pressure gauge 5. The pressure of air retained in the air
`reservoir 3 is detected by the pressure gauge 5, thereby allowing
`an operator to know the pressure of the body liquid. The air
`reservoir 3 is further provided with a conduit 7 for adjustment
`of liquid level. The liquid-level adjustment conduit 7 is adapted
`such that, when the amount of air retained in the air reservoir
`is excessively large, forceps or a clamp 8 can be opened to permit
`the air to be drawn out through a syringe or the like. In contrast,
`the liquid-level adjustment conduit 7 is adapted such that, when
`the amount of the air retained in the air reservoir is so small
`that the body liquid flows backward through the conduits 6 and
`7, the forceps or the clamp 8 can be opened, and air can be charged
`from the outside of the system using a syringe or the like to
`maintain the amount or pressure of air at an appropriate level.
`As mentioned above, the conventional pressure detector is
`designed to use a drip chamber mechanism for removal of bubbles
`in the body liquid. Further, a pouched mesh body 9 is provided
`at the lower side of the outer pipe 2. The pouched mesh body 9
`serves to filter coagulated matter, etc., generated in the
`above-mentioned drip chamber, a dialyzer, and the like, thereby
`preventing the coagulated matter from being refluxed into the body.
`The body liquid is allowed to pass from the inside to the outside
`of the pouched mesh body. The body liquid penetrating through
`a body-liquid filtering part formed of the mesh body is derived
`from another tube body 10. In the body-liquid processing circuit
`
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`using such a drip chamber as the pressure detector, the body liquid
`is processed while heparin is added to the body liquid for
`preventing coagulation of the body liquid (clotting in the case
`of blood), or urokinase is added thereto for dissolving coagulated
`material. Thus, in this kind of body-liquid processing circuit,
`even if the body liquid comes into contact with air, coagulation
`barely occurs in the body liquid. The provision of the air
`reservoir in such a circuit is not problematic.
`[0004]
`However, recently, the use of the above anticoagulant
`or the like leads to increased physiological burden on patients
`and increased tendency to bleed (in postoperative dialysis, in
`dialysis performed on a menstruating woman, and the like). It
`is being said that a decrease in usage of anticoagulants and the
`like, or no use thereof, is desirable. When the body liquid is
`processed while decreasing usage of the anticoagulant, or without
`using any anticoagulant, (hereinafter collectively referred to
`as a “decrease in usage”) in this way, the provision of a part
`for allowing air to be in contact with the body liquid in the
`circuit, such as the air reservoir, must be strictly avoided
`because the body liquid tends to be coagulated once it comes into
`contact with air. Accordingly, a pressure detector designed to
`completely avoid contact of the body liquid with air is required
`in place of the conventional pressure detector using the drip
`chamber.
`[0005]
`
`The creators of the present utility model have
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`diligently studied in order to provide a pressure detector that
`accommodates a filter therein, completely avoids contact of air
`with a body liquid to safely carry out the body-liquid processing
`with a reduced amount of anticoagulant, and can accurately detect
`a pressure of the body liquid. As a result of their studies, the
`present utility mode has been made. That is, the present utility
`model provides a pressure detector for a body-liquid processing
`circuit that is installed in a body-liquid processing circuit and
`adapted to detect a pressure of a body liquid circulating through
`the circuit, the pressure detector comprising: a body-liquid
`circulation pipe adapted to expand and contract by the pressure
`of the body liquid, the body-liquid circulation pipe being
`configured such that a body-liquid inflow pipe is liquid-tightly
`attached to one of both ends of a pouched body formed by two
`flexible sheets while a body-liquid outflow pipe is
`liquid-tightly attached to the other thereof, and that a filter
`for body-liquid filtration is disposed to separate an inside of
`the pouched body into a body-liquid inflow side and a body-liquid
`outflow side; an outer pipe formed of non-flexible material and
`adapted to liquid-tightly accommodate therein the body-liquid
`circulation pipe, thereby forming a sealed chamber with a fluid
`charged thereinto between the non-flexible outer pipe and the
`flexible body-liquid circulation pipe; and a pressure gauge
`attached to an end of a conduit connected to the sealed chamber,
`wherein the pressure detector is configured to detect a pressure
`
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`of the fluid charged into the sealed chamber, as the pressure of
`the body liquid flowing through the body-liquid circulation pipe.
`[0006]
`A pressure detector according to one embodiment of
`the present utility model will be described below with reference
`to the accompanying drawings. In the present utility mode, as
`shown in Fig. 2, two flexible sheets 11 and 15 are used to sandwich
`a filter 12 therebetween. A body-liquid inflow pipe 13 and a
`body-liquid outflow pipe 14 are positioned at respective short
`sides of the sheet 11 to be opposed to each other with the filter
`12 interposed therebetween. The sheets and the filter are
`overlapped one another and have their outer peripheries
`hermetically sealed at the same time by means for welding or
`adhesion or the like, allowing the body liquid to communicate with
`only openings of the body-liquid inflow pipe and the body-liquid
`outflow pipe to thereby form a pouched body-liquid circulation
`pipe 16 shown in Fig. 3. The body-liquid circulation pipe 16 is
`liquid-tightly accommodated in an outer pipe 17 made of
`non-flexible material and shown in Fig. 5. Thus, there is no
`unnecessary outflow of a fluid from the outer pipe 17 into the
`outside of the system, in addition to no leakage of fluid from
`between the body-liquid circulation pipe and the outer pipe. Into
`a sealed chamber 18 formed between the body-liquid circulation
`pipe and the outer pipe, compressible or non-compressible fluids,
`such as air, a physiological saline, and glucose, are charged.
`The sealed chamber 18 is provided with a conduit 19, the end of
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`which is coupled to a pressure gauge 20 shown in Fig. 6. Fig.
`6 is a cross-sectional view of the pressure detector taken along
`the line W-W’ of Fig. 5, illustrating a state of the pressure gauge
`20 connected to the conduit 19 of the pressure detector. The body
`liquid passing through the body-liquid circulation pipe 16
`expands and contracts the body-liquid circulation pipe according
`to the pressure of the body liquid. According to the change in
`volume of the pipe, the pressure of the fluid charged in the sealed
`chamber 18 changes, thereby enabling the pressure gauge 20 to
`detect the change in pressure of the fluid in the sealed chamber
`18 as the change in pressure of the body liquid. In the pressure
`detector of the present utility model, the fluid charged in the
`sealed chamber does not directly come into contact with the body
`liquid. Even in the use of air as the fluid, the body liquid can
`be prevented from coagulating, which is safety.
`[0007]
`Various types of pressure gauges can be used as the
`pressure gauge 20. A pressure transducer that electrically
`converts a pressure into an electrical signal can be preferably
`used. To transfer the pressure precisely, the conduit 19 should
`be made as short as possible and have a short diameter. Supposing
`that the body liquid leaks from the body-liquid circulation pipe,
`physiological saline and glucose solution are preferably used as
`the fluid in the sealed chamber because they are safer than air,
`and the liquid is superior as pressure transfer means because of
`the non-compressible fluid. The flexible materials used in the
`
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`body-liquid circulation pipe may be those having a degree of
`flexibility that expands and contracts in response to the pressure
`of the body liquid passing through the pipe. The flexible
`materials suitable for use usually include silicon, polyurethane,
`flexible polyvinyl chloride, and native or synthetic rubber. The
`non-flexible materials used for the outer pipe may be those having
`a degree of rigidity that does not absorb the change in pressure
`of the fluid charged in the sealed chamber. The non-flexible
`materials suitable for use usually include plastic materials,
`such as polypropylene, polyethylene, rigid polyvinyl chloride,
`and polycarbonate, and metals.
`[0008]
`The pressure detector of the present utility model
`includes the body-liquid circulation pipe made of flexible
`material and utilizes the expansion and contraction of the
`flexible material. The pressure detector is desirably used in
`a range where the circulating body liquid is at a positive pressure
`or slightly negative pressure. When the degree of decompression
`of the circulating body liquid becomes high, the flexible material
`parts tend to be collapsed largely, resulting in closed flow path,
`which is not desirable. Therefore, the pressure detector of the
`present utility model is particularly effective as the pressure
`detector for the body-liquid processing circuit in the positive
`pressure range and the slightly negative pressure range.
`[0009]
`Further, in the present utility model, the filter 12
`is provided inside the body-liquid circulation pipe 16. This is
`
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`
`for the purpose of avoiding the reflux, to the patient, of
`coagulated matter generated in the body-liquid processing. The
`filter is incorporated in the body-liquid circulation pipe and
`integrated with the body-liquid circulation pipe. In this case,
`as shown in Figs. 2 and 7, two sheets made of flexible material,
`e.g., vinyl chloride, are used and formed in an appropriate size.
`The filter 12 or 21 is sandwiched between the two sheets, and the
`body-liquid inflow pipe 13 and the body-liquid outflow pipe 14
`are positioned at the respective ends of the sheets to permit the
`body liquid to pass through the filter, whereby the sheets and
`the filter are overlapped one another. The outer peripheries of
`the sheets and filter are simultaneously sealed liquid-tightly
`by means such as welding or adhesion. To more liquid-tightly seal
`the sheets and filter, the body-liquid inflow pipe and the
`body-liquid outflow pipe are preferably made of material having
`adhesion or merging properties to the sheet. The filter is
`preferably one having a small resistance against the fluid
`pressure, for example, a meshed one.
`[0010]
`Accordingly, the configuration of the body-liquid
`circulation pipe in this way can easily produce the pressure
`detector incorporating the filter therein and exhibiting good
`workability during a manufacturing procedure.
`[0011]
`As mentioned above, the pressure detector in the
`present utility model is adapted to avoid contact between the body
`liquid and air and thus can safely carry out the body-liquid
`
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`processing with a reduced amount of anticoagulant without causing
`coagulation of the body liquid. Further, the pressure detector
`accommodates the filter in the body-liquid circulation pipe and
`thus has the effect of eliminating the necessity of separately
`providing a filtering device, which is practically very useful.
`
`Brief Description of the Drawings
`
`Fig. 1 is a cross-sectional view of a conventional drip
`chamber. Fig. 2 is a perspective view showing the assembly
`structure of a body-liquid circulation pipe used in the pressure
`detector in a present utility model. Fig. 3 is a diagram showing
`the body-liquid circulation pipe. Fig. 4(a) is a cross-sectional
`view taken along the line X-X’ of Fig. 3, Fig. 4(b) is a
`cross-sectional view taken along the line Y-Y’ of Fig. 3, and Fig.
`4(c) is a cross-sectional view taken along the line Z-Z’ of Fig.
`3. Fig. 5 is a perspective view of the pressure detector. Fig.
`6 is a cross-sectional view taken along the line W-W’ of Fig. 5.
`Fig. 7 is a perspective view showing the assembly structure of
`another body-liquid circulation pipe. Fig. 8 is a perspective
`view of the body-liquid circulation pipe.
`1 (cid:152)(cid:152)(cid:152) Tube body, 2, 17 (cid:152)(cid:152)(cid:152) Outer pipe, 3 (cid:152)(cid:152)(cid:152)Air reservoir, 4 (cid:152)(cid:152)(cid:152)
`Body liquid, 5, 20 (cid:152)(cid:152)(cid:152) Pressure gauge, 6, 19 (cid:152)(cid:152)(cid:152) Conduit, 7 (cid:152)(cid:152)(cid:152) Conduit,
`8 (cid:152)(cid:152)(cid:152) Clamp, 9 (cid:152)(cid:152)(cid:152) Mesh body, 10 (cid:152)(cid:152)(cid:152) Tube body, 11, 15 (cid:152)(cid:152)(cid:152) Flexible sheet,
`12, 21 … Filter, 13 … Body-liquid inflow pipe, 14 … Body-liquid
`outflow pipe, 16, 22 … Body-liquid circulation pipe, 18 … Sealed
`
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`pipepipe
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`13
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`Fig. 1
`
`Fig. 2
`
`Fig. 3
`
`Fig. 7
`
`Fig. 4
`
`Fig. 6
`
`Fig. 5
`
`Fig. 8
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`TRANSLATOR’S DECLARATION
`
`I,TatsuoEflfifllofHARAPatentTranslationresidingat]Jr53—2U1,
`
`Minoh 2—chome, Minoh—shi, Osaka, Japan, anla Japanese language
`
`translator with over twenty five years of experience
`
`translating technical,
`
`legal, and business documents from
`
`Japanesezto English and fron1Englisr1to Japanese. Being fluent
`
`in both the Japanese and English languages,
`
`I certify under
`
`penalty of perjury under the laws of the United States that:
`
`l.
`
`To the best of my knowledge and belief,
`
`the preceding
`
`document is a true and correct English.translation of Japanese
`
`Examined Utility Model Publication No. S62—5l72. Paragraph
`
`numbers have been added,
`
`to aid in citation;
`
`2. All statements made herein of my own knowledge are true
`
`and that all statements made on information and belief are
`
`believed to be true; and
`
`3. Thisdeclarationwasmadewithknowledgethatwillfulfalse
`
`statements and the like so made are punishable by fine or
`
`imprisonment or both under 18 U.S.C. § 1001.
`
`Date}
`
`January 28, 2016
`
` Translator Name:
`
`“
`
`‘
`
`“E
`
`I
`
`'
`
`Tatsuo HARA
`
`000015
`
`Nipro Ex. 1028
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`Nipro Ex. 1028
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`000015

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