JP 61-143069 A
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`Japan Patent Office
`Patent Laying-Open Gazette
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`Patent Laying-Open No.
`Date of Laying-Open:
`International Class(es):
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`ID Code Agency Ref.No.
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`Examination requested. No. of Claims: 1
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`S61-143069
`June 30, 1986
`A61M 1/14
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`6675-4C
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`(6 pages in all)
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`Title of the Invention:
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`Patent Appln. No.
`Filing Date:
`Inventor(s):
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`Applicant(s):
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`Pressure Measuring Method for Blood
`Circuit
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`S59-266907
`December 18, 1984
`Hiromichi MINAMI
`4-7-10 Sakasedai, Takarazuka-shi
`
`Nihon Medical Engineering Kabushiki
`Kaisha
`2-5-40 Ohama-cho, Amagasaki-shi
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`Patent Attorney Tadashi Mizowaki
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`Agent(s):
`(1other)
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`Specification
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`1. Title of the Invention
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`Pressure Measuring Method for Blood Circuit
`2. Scope of Claims for Patent
`[Claim 1]
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`A pressure measuring method for a blood circuit, comprising:
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`dividing an inside of a sealed container into a blood chamber and an air
`chamber with a diaphragm interposed therebetween;
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`connecting a blood circuit in a manner that allows blood to circulate in said
`blood chamber; and
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`measuring a pressure of air in said air chamber.
`[Claim 2]
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`The pressure measuring method for the blood circuit according to claim 1,
`wherein an air content in said air chamber is adjustable.
`3. Detailed Description of the Invention
`(Industrial Applicable Field)
`[0001]
`The invention relates to a pressure measuring method for a blood circuit
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`applicable for detecting pressure in a device such as a hemodialysis machine or
`cardiopulmonary bypass device, and for automatically controlling such a device.
`(Prior Art)
`[0002]
`Conventionally, there are devices universally used, such as an artificial kidney
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`device (dialysis machine), and cardiopulmonary bypass device. The dialysis machine
`is a device to be used in a human body with renal failure to purify blood in place of the
`kidneys, by removing waste product in the body. The cardiopulmonary bypass device
`is a device used in the event of a cardiac surgery to provide blood with oxygen in place
`of the heart. To use either of these devices, a blood circuit to be extracorporeally
`circulated is fabricated and operated as required for blood within the blood circuit.
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`Therefore, measuring a blood pressure at certain points in the blood circuit is necessary
`to automatically perform the operation or observe whether the operation is normally
`carried out.
`[0003]
`Fig. 9 is a drawing of an example of a conventional dialysis machine for
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`positive-pressure dialysis. Referring to Fig. 9, a blood vessel in extremity of a body A
`is punctured with cannulae 1a and 1b and used as an inlet and an outlet for blood to be
`extracorporeally circulated. A certain flow volume of blood suctioned by a blood
`pump 2 and flowing out through the cannula 1a is supplied to a dialyzer 3, and tube 5 is
`partly narrowed by restrictor 4 to generate a positive pressure in blood in the dialyzer 3.
`In the blood inlet and outlet of the dialyzer 3 are installed air chambers 6a and 6b and
`pressure gauges 7a and 7b to check on an ultrafiltration pressure. A feed-in path 8a
`and a discharge path 8b are connected to the dialyzer 3 to feed a dialyzing fluid
`separately prepared. To dialyze blood through this dialysis machine, the blood pump
`2 is rotated with the dialyzing fluid being continuously supplied through the feed-in
`path 8a. Then, the positive pressure is generated by tightening the restrictor 4 and
`regulated to an appropriate ultrafiltration pressure with the pressure gauges 7a and 7b
`being checked.
`[0004]
`The inventors of this invention previously proposed the dialysis machines
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`described in, for example, Japanese Patent Application Nos. 1983-57147 and 1983-
`212895. The inventions are directed to improving the dialyzing efficiency of these
`dialysis machines to shorten required dialyzing time, and achieving better safety by
`automatically observing any abnormal events during the dialysis.
`[0005]
`These dialysis machines are both equipped with an air chamber to measure a
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`blood pressure. Fig. 10 is an enlarged view of the air chamber. As illustrated in this
`drawing, blood c and air d are constantly in contact with each other in an air chamber 6.
`This air-blood contact accelerates coagulation of blood in a reaction system, resulting
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`in advanced coagulation. Clots formed in coagulation may be a factor of clogging in
`the dialyzer, leading to a poor dialyzing efficiency, as well as other unacceptably
`unfavorable events for hemodialysis, which necessarily demands that fluidity of blood
`be kept. An option often employed to prevent any of these unfavorable events is
`injection of an anticoagulant such as heparin. This is, however, possibly associated
`with failure to arrest hemorrhage in some patients. It is a very complicated and
`difficult procedure to determine and administer a minimum effective dosage of heparin
`for each case. To adjust the liquid level of blood c in the air chamber 6 and the
`pressure of air d, an air-d content is moderately adjusted by use of an injector 10 with a
`clamp 9 for blocking a tube 9a being loosened. If this adjustment is inadequate,
`however, the liquid level of blood c may be elevated to an abnormally high level, and
`the pressure gauges 7a and 7b may become no longer usable or blood may be
`contaminated with bacteria. On the other hand, an abnormally low liquid level may
`invite air into the tube 5, possibly placing a patient in life-risking danger. Further,
`there are some drawbacks with the air chamber 6 in handleability; this air chamber in
`use needs to be retained in a certain posture, and the tube 5 used for a pipe may be
`lengthened and bentkinked, or may narrow an installation area of the pressure gauges
`7a and 7b and injector 10.
`(Problems to be Solved by the Invention)
`[0006]
`The invention was accomplished to solve the various problems associated with
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`the use of such an air chamber by enabling pressure measurement without any contact
`between air and blood in an extracorporeal circuit.
`(Technical Means for Solving the Problems)
`[0007]
`A pressure measuring method according to the invention includes: dividing
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`inside of a sealed container 11, 33, 37, 40 into a blood chamber a, and an air chamber b
`with a diaphragm 12 interposed therebetween; connecting a blood circuit in a manner
`that allows blood to circulate in the blood chamber a; and measuring a pressure of air in
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`the air chamber b.
`(Embodiments)
`[0008]
`Referring to the accompanying drawings, the invention is hereinafter described
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`based on an example.
`[0009]
`Referring to Fig. 1, an inside of a sealed container 11 is divided by a diaphragm
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`12 into two chambers; blood chamber a, and air chamber b. Container 11 has an inlet
`14 and an outlet 15 communicating with blood chamber a, and a first connection port
`16 and a second connection port 17 communicating with air chamber b. Inlet 14 and
`outlet 15 are connected in series to a blood circuit by way of tubes 18 and 19 to allow
`blood to flow into blood chamber a from inlet 14 and flow out from outlet 15. First
`connection port 16 and second connection port 17 are respectively connected to a
`pressure gauge 22 and an injector 23 for pumping purpose through tubes 20 and 21.
`Tube 21 is clamped by a clamp 24 and thereby blocked.
`[0010]
`A pressure converter 25 refers to a device including container 11 and
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`diaphragm 12. Pressure converter 25 is more specifically structured as described
`below. Referring to Fig. 2, container 11 is composed of two container members 11a
`and 11a divided in halves in an identical shape and facing each other. Between
`flanges 11b and 11b of container members 11a and 11a is interposed diaphragm 12
`having an identically shaped outer periphery. These members are welded to one
`another to be tightly sealed. Container member 11a is formed from a polymer
`material such as vinyl chloride, rigid vinyl chloride, polycarbonate, or silicon rubber.
`Container member 11a is integral with inlet 14 and outlet 15 or first connection port 16
`and second connection port 17. Diaphragm 12 has an appropriate elasticity and is
`formed from the same material as that of container member 11a to facilitate welding.
`Container member 11a or diaphragm 12 is preferably a transparent member so that a
`current status inside can be observed.
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`[0011]
`Fig. 3 is a drawing of a dialysis machine wherein a measuring device 26 thus
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`structured is installed in place of conventional air chamber 6a illustrated in Figs. 9 and
`10. Referring to Fig. 3, reference characters 22a and 22b denote the pressure gauge,
`23a and 23b denote the injector, 24a and 24b denote the clamp, 25a and 25b denote the
`pressure converter, and 26a and 26b denote the measuring device. These structural
`elements are identical to those illustrated in Fig. 1. A reference character 27 denotes a
`filter, which will be described later. Referring to Figs. 1 and 3, operations of
`measuring devices 26, 26a, and 26b are described. As a preparatory step, an adequate
`quantity of saline solution is circulated in the blood circuit connected through tube 5,
`and air evacuators of the respective devices are used or the respective devices are
`oscillated to fully evacuate air from the blood circuit. Then, blood is introduced into
`the circuit. With a blood pump 2 suspended, air content of respective air chambers b
`are respectively adjusted by means of injectors 23a and 23b so that a pointer of
`respective pressure gauges 22a and 22b becomes zero. During the dialysis performed
`with blood pump 2 being rotated, blood is circulated in respective blood chambers a.
`Then, diaphragm 12 is dilated toward air chamber b by the pressure of blood. The
`capacity of air chamber b accordingly decreases and air pressure therein
`correspondingly increases, resulting in equilibrium. The pressure of blood can be
`known by measuring the air pressure at the time by pressure gauge 22. In a case
`where a blood pressure is high, air is blown into respective air chambers b by injectors
`23a and 23b so that a degree of deformation of diaphragm 12 becomes as small as
`possible.
`[0012]
`In the dialysis machine illustrated in Fig. 3 so structured as to avoid any contact
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`between blood and air in pressure converters 25a and 25b, there is no risk of
`accelerating blood coagulation as in the conventional air chamber. This greatly
`reduces the heparin dosage and the risk of bacterial infection. Blood chamber a
`filled with blood may eliminate the risk that air in the air chamber flows into the blood
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`circuit including tube 5. The air content adjustments by injectors 23a and 23b are
`facilitated, and it is no longer possible for the pressure gauges 22a and 22b to be
`disabled by an inflow of blood. Because pressure converters 25a and 25b are allowed
`to use in an arbitrary position, tube 5 can be shortened to a minimal length. This
`reduces a flow volume of blood to be extracorporeally circulated and greatly improves
`the handleability.
`[0013]
`In the illustration of Fig. 3, optionally, the positive pressure may be generated
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`by pressure converter 25b to omit restrictor 4. By presetting a pressure equivalent to
`the positive pressure in air chamber b of pressure converter 25b, blood flowing out
`from dialyzer 3 is not allowed to circulate in blood chamber a of pressure converter 25b
`unless the blood has a pressure greater than or equal to the preset pressure. This
`enables a certain preset positive pressure to be applied to dialyzer 3 irrespective of a
`flow volume of blood. In that case, in converter 25b, it is necessary to close the
`opening of inlet 14 into blood chamber a but not to close the opening of outlet 15 into
`blood chamber a by forming suitable small grooves in the opening when diaphragm 12
`illustrated in Fig. 1 is pushed against the side inner wall of container 11 closer to blood
`chamber a.
`[0014]
`Filter 27 serves to remove air and foreign matter such as blood clot that may be
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`contained in blood. Describing its structure referring to Fig. 4, filter 27 has a filter
`container 28 identical to container 11 of pressure converter 25 described earlier, and a
`mesh filter element 29 suitably is replaced with diaphragm 12. Tubes 5, 5 are
`connected to connection ports 30a and 30d located at diagonally opposite positions to
`allow blood flow to pass through filter element 29. Injectors 23c and 23d are
`connected to the other connection ports 30b and 30c by way of tubes 31a and 31b, and
`these tubes 31a and 31b are clamped by clamps 24c and 24d. Thus structured, blood
`flowing into filter container 28 through connection port 30a is filtered through filter
`element 29 and flows out from connection port 30d, however, air contained in blood, if
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`any, is entrapped upward in an air reservoir 31 and should be removed from connection
`port 30c by means of injector 23d at suitable time intervals. The foreign matter, such
`as blood clot, blocked by filter element 29 should be removed by means of injector 23c
`from connection port 30b. Filter 27 should be situated so that connection port 30d is
`not located at an upper position.
`[0015]
`In this example, pressure gauge 22 is a Bourdon pressure gauge; however, it
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`may be a liquid column pressure gauge or a strain gauge, or a combination of
`semiconductor sensor and a suitable display device. Optionally, upper and lower
`pressure limits may be defined and used as control signals. Injector 23 may be
`replaced with a suitable pump. Pressure gauge 22 and injector 23 may be connected
`to one of first connection port 16 and second connection port 17 so as to diverge from
`the connected port. In that case, the other connection port becomes unnecessary and
`should be closed with a blank plug or omitted in the first place.
`[0016]
`Pressure converter 25 may be replaced with a device in a shape illustrated in
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`Figs. 5 to 7. In the case of a pressure converter 32 illustrated in Fig. 5, one of the
`container members of container 33, a container member 33a, is in the form of a flat
`plate, and blood may flow in and out from connection ports 35a and 35b formed in flat
`container member 33a. Employing a negative-pressure dialysis or any other dialyzing
`method may generate a negative blood pressure. In such case, blood may flow in and
`out from connection ports 35c and 35d formed in a curved container member 33b.
`Referring to a pressure converter 36 illustrated in Figs. 6A and 6B, a container 37 is
`structurally characterized in that four identical container members 37a are situated
`facing one another, and flanges 37b are welded with diaphragm 12 interposed
`therebetween. In this container, connection ports 38a, 38b, and 38c, 38d are
`respectively aligned on a straight line to facilitate the connection of tubes and to allow
`for smooth blood flow. In a pressure converter 39 illustrated in Fig. 7, inner face parts
`of container members 40a, 40a on one side of container 40 provide the only passage for
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`blood from connection port 41a to connection port 41b.
`[0017]
`These pressure converters 25, 33, 36, and 39, as well as the blood circuit
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`illustrated in Fig. 3, are applicable to other hemodialyzing methods such as negative-
`pressure dialysis, and single needle dialysis, a blood circuit for use with the dialyzing
`method described in Japanese Patent Application Nos. 1983-57147 and 1983-212895,
`and a blood circuit for methods other than the dialysis. In any of these circuits, these
`pressure converters allow for pressure measurement without any contact between blood
`and air.
`[0018]
`Filter 27 may have different shapes other than the one illustrated in Fig. 4, for
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`example, may be a filter in which a filter element is replaced with diaphragms 12 in
`converters 36 and 39 illustrated in Figs. 6A and 6B, or Fig. 7, or may have a shape
`illustrated in Fig. 8. Describing a filter 42 illustrated in Fig. 8, a filter container 43
`has a larger inner depth. Filter 42 is usable, in addition to the usage described
`referring to Fig. 4, as a blood collecting tool for blood tests. Blood tests, except blood
`cell tests, only require a body fluid such as plasma or serum, and the filter may be used
`to selectively filter the body fluid so as to prevent loss of blood cells. Moreover, a
`lower container member 43a may be used as a blood cell precipitation tank to prevent
`blood cells or protein from clogging the filter element and remove a resulting
`supernatant fluid through a connection port 44a or 44b on the upper side. For the
`purpose, filter element 29 should be a filter passing only a target material therethrough.
`[0019]
`All of pressure converters 25, 33, 36, and 39 and filters 27 and 42 can be
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`produced in small sizes with a remarkable strength. These members are, therefore,
`easy to handle and carried conveniently with users. Further advantageously, they are
`simply structured and accordingly easily produced inexpensively. Pressure converters
`25, 33, 36, and 39 are not just available for blood pressure measuring alone. These
`converters, wherein the air pressure in air chamber b can be applied to blood in blood
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`chamber a as pressure by way of diaphragm 12, may be further used as blood tanks for
`temporary storage of blood in blood chamber a by controlling circulated blood using an
`appropriate valve, or release of blood into flow paths under pressure.
`(Effects of the Invention)
`[0020]
`The invention enables pressure to be measured without any contact between
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`blood and air in the blood circuit, thereby solving the problem with the conventional air
`chamber: blood coagulation accelerated by air-blood contact. This significantly
`reduces a required heparin dosage administered as an anticoagulation agent,
`eliminating the risk of adverse impact on a patient due to heparin overdose and inviting
`cost reduction because of significantly reduced heparin dosage. Other advantages are:
`reduced risks of bacterial infection and eliminated risk of disabling the pressure gauge
`due to intake of blood therein, and much shorter tubes structuring the blood circuit with
`a greatly improved handleability. Unlike the prior art, the blood chamber filled with
`blood may avoid the risk of inviting air from the air chamber into the blood circuit.
`This omits monitoring-required labor and offers better safety for patients.
`4. Brief Description of the Drawings
`[0021]
`Fig. 1 is a sectional view of an example of a measuring device for which a
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`method according to the invention is performed.
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`Fig. 2 is a planar view of a pressure converter illustrated in Fig. 1.
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`Fig. 3 illustrates an example of a dialysis machine using the measuring device
`illustrated in Fig. 1.
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`Fig. 4 is a sectional view of a filter according to an example used in the dialysis
`machine illustrated in Fig. 3.
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`Figs. 5, 6A, 6B, and 7 are respectively sectional and side views of the pressure
`converter according to another example.
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`Fig. 8 is a sectional view of a filter according to another example.
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`Fig. 9 illustrates an example of a conventional dialysis machine.
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`Fig. 10 illustrates a conventional air chamber.
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`[Description of the Reference Characters]
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`5, 18, 19 … tube (blood circuit), 11, 33, 37, 40 … container, 12 … diaphragm,
`22 … pressure gauge, a … blood chamber, b … air chamber, c … blood, d … air
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`Applicant:
`Nihon Medical Engineering Co., Ltd.
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`Agent:
`Tadashi MIZOWAKI, Patent Attorney
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`Yukio KUBO, Patent Attorney
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`Fig. 1
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`Fig. 2
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`JP 61-143069 A
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`Fig. 4
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`Fig. 5
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`Fig. 3
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`Fig. 6A
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`Fig. 6B
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`Fig. 7
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`Fig. 8
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`Fig. 9
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`Fig. 10
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`TRANSLATOR’S DECLARATION
`
`I, Tatsuo HERA of I-[ARA Patent Translation residing at l1—53—201,
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`Minoh 2—chome, Minoh—shi, Osaka, Japan, anla Japanese language
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`translator with over twenty five years of experience_
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`translating technical,
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`legal, and_business documents from
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`Japanese to English and fron1English.to Japanese. Being fluent
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`in both the Japanese and English languages,
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`I certify under
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`penalty of perjury under the laws of the United States that:
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`1.
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`To the best of my knowledge and belief,
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`the preceding
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`document is a true and correct English.translation of Japanese
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`Patent Publication No. S61—l-43069. Paragraph numbers have been
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`added,
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`to aid in citation.
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`2. All statements made herein of my own knowledge are true
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`and that all statements made on information and belief are
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`believed to be true; and
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`3. Thisdeclarationwasmadewithknowledgethatwillfulfalse
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`statements and the like so made are punishable by fine or
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`imprisonment or both under 18 U.S.C. § 1001.
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`Date: December 18, 2015
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`Translator Name:
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`Tatsuo HARA
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