(19) Japan Patent Office (JP)
`
`(12) Patent Application Laid-Open Publication (A)
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`(11) Publication Number: Japanese Patent Application Laid-Open Publication No. S64-29267
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`(43) Publication Date: January 31, 1989
`(51) Int. Cl.4
`A61M 1/10
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`Identification Code
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`310
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`JPO Reference Number
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`7720-4C
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`Request for Examination: Not filed
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`Number of Invention: 1 (7 pages in total)
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`(54) Title of Invention: Blood Pump
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`(21) Application Number: Japanese Patent Application No. S62-185958
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`(22) Filing Date: July 24, 1987
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`(72) Inventor: Masaki SATO
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`c/o Toyo Boseki Co., Ltd., Research Institute
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`2-1-1 Katata, Otsu-shi, Shiga
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`(72) Inventor: Kaoru SUGIHARA
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`c/o Toyo Boseki Co., Ltd., Research Institute
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`2-1-1 Katata, Otsu-shi, Shiga
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`(72) Inventor: Osamu UEMOTO
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`c/o Toyo Boseki Co., Ltd., Research Institute
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`2-1-1 Katata, Otsu-shi, Shiga
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`(71) Applicant: Toyo Boseki Co., Ltd.
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`2-2-8 Dojimahama, Kita-ku, Osaka-shi, Osaka
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`(74) Agent: Patent Attorney Shusaku YAMAMOTO
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`Specification
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`Title of invention
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`Blood Pump
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`Claims
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`1. A blood pump that has a periphery of a diaphragm attached to a housing inner
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`1.
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`2.
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`circumferential surface so as to divide a blood pump housing into a blood chamber and an air
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`chamber, and circulates blood by pumping the diaphragm in pulses to cause the blood to once
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`flow into the blood chamber and then flow out from the blood chamber,
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`characterized in that the diaphragm is configured to have a thick peripheral portion
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`and become gradually thinner towards a center portion.
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`2. The blood pump of claim 1, characterized in that the film thickness of the
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`peripheral portion is 0.2 to 2.0 mm, and the thickness of the center portion is 50 to 90% of the
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`film thickness of the peripheral portion.
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`3.
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`Detailed Description of Invention
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`(Industrial Applicability)
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`[0001]
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`The present invention relates to a diaphragm type blood pump used in the field of
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`cardiac surgeries.
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`(Background Art)
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`[0002]
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`In recent years, in the field of cardiac surgeries, a circulation assisting method that
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`assists blood circulation during surgery and the like is being employed, and for example, an
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`application of an intra-aortic balloon pumping method or a veno-arterial bypassing method on
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`seriously ill heart disease patients may save the lives of such patients. However, for patients
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`of heart failures who had gone into a serious condition by acute myocardial infarction or
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`during open heart surgeries, problems are present in that the aforementioned intra-aortic
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`balloon pumping method would not be effective due to the limit cast on its circulation
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`assisting performance, and with the veno-arterial bypassing method, a large amount of
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`anticoagulant must be used, which results in the presence of bleeding tendency, and
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`occurrences of dysfunctions in other organs, or the like.
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`[0003]
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`As a substitute to the intra-aortic balloon pumping method and the veno-arterial
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`bypassing method having such problems, a method of using an auxiliary artificial heart is
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`recently being employed. A blood pump of the auxiliary artificial heart has the ability to
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`take over partial or entire cardiac function of a patient who has gone into even a more serious
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`condition of heart failure due to acute myocardial infarction or post-operational cardiogenic
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`shock after the open heart surgery.
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`[0004]
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`A conventional blood pump for the auxiliary artificial heart has a diaphragm with a
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`uniform thickness that divides an inside of an oval-spherical blood pump main body into two
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`chambers, namely a blood chamber and an air chamber, where the blood chamber is provided
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`therein with a blood inflow tube that allows the body blood to flow into the blood chamber
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`and a blood outflow tube that allows the blood in the blood chamber to circulate in the body.
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`A contraflow-preventing valve for preventing the blood in the blood chamber from adversely
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`flowing into the blood inflow tube is installed between the blood inflow tube and the blood
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`chamber being the housing, and a contraflow-preventing valve for preventing the blood in the
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`blood outflow tube from adversely flowing into the blood chamber is installed between the
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`blood outflow tube and the blood chamber.
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`[0005]
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`In such a conventional blood pump, the blood chamber first is inflated by sucking
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`the diaphragm into the air chamber by discharging the air in the air chamber, and introducing
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`the blood into the blood chamber via the blood inflow tube from within the body. Then, air
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`is supplied to the air chamber to press the diaphragm into the blood chamber, whereby the
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`blood chamber contracts to guide the blood in the blood chamber into the blood outflow tube.
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`Accordingly, the air supply to the air chamber and the air discharge from the air chamber are
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`repeated to pump the diaphragm in pulses to circulate the blood.
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`(Problem Aimed to be Solved by Invention)
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`[0006]
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`In the conventional blood pump, the pulsing diaphragm has the unique film
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`thickness. Due to this, a large negative pressure must be applied to the diaphragm for
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`sucking a center portion of the diaphragm having the same thickness as its peripheral portion
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`toward an air chamber side upon inflating the blood chamber to introduce blood flow into the
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`blood chamber. With such an increased negative pressure, there is a risk that the blood
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`might flow into the blood chamber in a surge, as a result of which blood emissary speed may
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`become large, and hemolysis may occur. With a unique film thickness for the diaphragm,
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`stress applied to the diaphragm accumulates locally upon pulsing the diaphragm, and the
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`diaphragm is pumped in pulses in a state of being undulated. As a result of this, the portions
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`where the stress in the diaphragm is accumulated has lower durability, and breakage may
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`occur from that portion. Further, when the diaphragm is rippled, there is also a risk that a
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`part of the blood stagnates in the blood chamber. With such stagnation of blood in the blood
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`chamber, anti-coagulant performance would be lost, and there would be higher chances of
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`blood clots.
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`[0007]
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`The present invention solves the above conventional problems, and aims to provide a
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`blood pump with high durability, and that can pump its diaphragm in pulses by a relatively
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`small driving force, as a result achieving less risk for undulation of the diaphragm upon being
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`pulsed, thus maintaining its anti-coagulant performance, and that has no risk of hemolysis.
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`(Means for Solving Problem)
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`[0008]
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`The present invention is a blood pump that has a periphery of a diaphragm attached
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`to a housing inner circumferential surface so as to divide a blood pump housing into a blood
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`chamber and an air chamber, and circulates blood by pumping the diaphragm in pulses to
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`cause the blood to once flow into the blood chamber and then flow out from the blood
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`chamber, characterized in that the diaphragm is configured to have a thick peripheral portion
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`and become gradually thinner towards a center portion, by which the above aims are fulfilled.
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`(Embodiment)
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`[0009]
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`Hereinbelow the present invention will be described with reference to drawings.
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`As shown in FIG. 1 and FIG. 2, the blood pump of the present invention includes an
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`oval-spherical housing 10, and a semispherical diaphragm 20 that divides the inside of a
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`blood pump main body.
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`[0010]
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`The housing 10 is provided with a blood inflow tube part 11a (shown only in FIG. 1)
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`and a blood outflow tube part 11b (shown only in FIG. 2) projecting therefrom, and includes
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`a semispherical main body part 11 that configures an outer shell of a blood chamber 14, and a
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`back plate part 12 that configures an outer shell of an air chamber 15 by being joined with a
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`peripheral portion of the main body 11 in an airtight manner.
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`At least an inner circumferential surface of the main body part 11 of the housing 10
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`is formed of an anti-coagulant polymer material. Thus, an entirety of the main body 11 is
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`formed for example of the anti-coagulant polymer material, or is formed of plastic and have
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`its inner circumferential surface covered by the anti-coagulant polymer material.
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`[0011]
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`An outer peripheral edge of a diaphragm 20 formed in a semispherical shape by the
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`anti-coagulant polymer material is attached airtight to the inner circumferential surface on the
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`peripheral part of the main body part 11 of the housing 10, and it is formed integral with the
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`anti-coagulant polymer material of the inner circumferential surface of the main body part 11.
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`The diaphragm 20 divides the inside of the housing 10 into the blood chamber 14 and the air
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`chamber 15.
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`[0012]
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`As shown in FIG. 1, the blood inflow tube part 11a provided projecting from the
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`main body part 11 of the housing 10 has a blood inflow tube 31 connected thereto. The
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`blood inflow tube part 11a is provided with a contraflow-preventing valve 11c that is opened
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`only when blood flows into the blood chamber 14 of the housing 10 from the blood inflow
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`tube 31, and prevents the blood from flowing out into the blood inflow tube 31 from the
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`blood chamber 14.
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`[0013]
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`Further, as shown in FIG. 2, the blood outflow tube part 11b has a blood outflow
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`tube 32 connected thereto. The blood outflow tube part 11b is provided with a contraflow-
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`preventing valve 11d that is opened only when the blood in the blood chamber 14 of the
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`housing 10 flows out to the blood outflow tube 32, and prevents the blood from flowing into
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`the blood chamber 14 from the blood outflow tube 32.
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`[0014]
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`The back plate part 12 is formed for example of composite resin, and has a shape to
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`which an air connector 16 can be attached. The air connector 16 to be attached to the back
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`plate 12 has an air tube connected to an air pump and the like coupled thereto, where air is
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`supplied to the air chamber 15 via the air connector 16, and the air is discharged from the air
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`chamber 15. Due to this, the diaphragm 20 in the housing 10 is pumped in pulses so as to
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`contract and inflate the blood chamber 14.
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`[0015]
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`A film thickness of the diaphragm 20 is configured such that its peripheral part is
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`made thick, and becomes gradually thin towards a center part. The film thickness of the
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`diaphragm 20 is configured for example as follows for example. As shown in FIG. 3, a
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`radius of the diaphragm 20 is set to be R, and the diaphragm 20 is divided concentrically into
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`three regions, namely a center part C, a peripheral part A, and a center part B between the
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`aforementioned parts. At this occasion, the center part C is set as a region within a
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`concentric circle of a radius R/4 relative to the diaphragm 20, the center part B is set as a
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`region on the outer side of the center part C, and as a region within a concentric circle of a
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`radius R/2 relative to the diaphragm 20, and further the peripheral part A is set to be a region
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`on the outer side of the center part B. The diaphragm 20 is configured, with respect to such
`three regions, that a film thickness TA of the peripheral part A is in a range of 0.2 to 2.0 mm, a
`film thickness TB of the intermediate part B is 70 to 95% of the film thickness TA of the
`peripheral part A, and further, a film thickness TC of the center part C is 50 to 90% of the film
`thickness TA of the peripheral part A, as a result of which a smooth film thickness gradient is
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`formed from the outer circumferential edge toward the center as a whole.
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`[0016]
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`An inner circumferential surface of the main body part 11 of the housing 10 and the
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`diaphragm 20 in the blood pump as configured above are formed by using injection molding
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`method, slash molding method, centrifugal casting method and the like using an anti-
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`coagulant polymer material. A case of manufacturing the blood pump of the present
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`invention by forming the diaphragm 20 and the inner circumferential surface of the main
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`body part 11 of the housing 10 by the centrifugal casting method using the anti-coagulant
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`polymer material will be described below.
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`[0017]
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`Firstly, a diaphragm having a predetermined film thickness gradient is formed by the
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`centrifugal casting method. In this formation, 10% to 20% solution of polyether urethane
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`urea (for example, TM series, manufactured by Toyo Boseki Co., Ltd.) being the anti-
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`coagulant polymer material is filled in a diaphragm mold by 2 to 15g, or preferably by 7 to
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`10g, a centrifugal force is applied by rotation while heating the mold so that the solution is
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`adhered to an entire region of an inner circumferential surface of the mold. After this
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`solution is sufficiently dried, a solution that has 2 to 5% less concentration than the
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`aforementioned solution is filled on the inner circumferential surface of the mold by 5 to 20g,
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`or preferably 10 to 20g. Then, the centrifugal force is applied by rotation while heating the
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`mold so that the solution is adhered to the entire region of the inner circumferential surface of
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`the mold. The solution is then dried. As above, the diaphragm 20 having the
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`predetermined film thickness gradient is formed by changing the solution concentration and
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`the rotation speed of the mold upon applying the centrifugal force.
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`[0018]
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`Accordingly, the diaphragm 20 having the predetermined film thickness gradient is
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`obtained. In order to integrally attach the diaphragm to the inner circumferential surface of
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`the main body part 11 of the housing 10, the mold including the diaphragm is placed to cover
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`the main body part 11 of the housing 10 formed in a predetermined shape by a composite
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`resin or anti-coagulant polymer material, 3 to 10% solution of an anti-coagulant polymer
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`material (for example, TM series, manufactured by Toyo Boseki Co., Ltd.) of a similar type
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`as the diaphragm 20 is poured onto the inner circumferential surface of the main body part 11,
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`unnecessary solution is removed after 1 to 20 minutes of degassing, and the adhered solution
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`is then dried. With such a process being repeated 3 to 8 times, or preferably 4 to 6 times, the
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`main body part 11 of the housing 10, of which inner circumferential surface is covered by the
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`anti-coagulant polymer material, and including the diaphragm 20 integrated with the inner
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`circumferential surface and being formed of the anti-coagulant polymer material with the
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`predetermined film gradient, is obtained. Further, the blood pump of the present invention
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`is obtained by joining the main body part 11 airtight with the back plate part 12 formed in a
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`predetermined shape by composite resin.
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`[0019]
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`In the blood pump of the present invention, as the anti-coagulant polymer materials
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`to configure the diaphragm 20 and the inner circumferential surface of the main body part 11
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`of the housing 10, a material having anti-coagulant performance may suitably be used, such
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`as polyether urethane urea, polyether urethane, polyester urethane urea, polyester urethane,
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`polyether urethane urea-polydimethylsiloxane copolymer, polyether urethane-
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`polydimethylsiloxane copolymer, or polyester urethane –polydimethylsiloxane copolymer.
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`Further, any anti-coagulant polymer material that may heretofore be developed may be used.
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`The blood pump of the present invention is not limited to the one depicted in FIGS. 1 and 2.
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`(Working Effects)
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`[0020]
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`A pulsation movement of the diaphragm 20 in the blood pump of the present
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`invention is shown in FIG. 4. The diaphragm 20 has the thick peripheral part A and the thin
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`center part C, so the stress on the center part C is small; and under a normal pressure, as
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`shown in FIG. 4 (i), the diaphragm 20 is sucked into the air chamber 15 and the blood
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`chamber 14 is in a state of somewhat being inflated. From such a state, when the air is
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`supplied to the air chamber 15 and positive pressure is applied to the diaphragm 20, the
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`diaphragm 20 is pressed into the blood chamber 14 from the center part C with the small
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`stress and the blood chamber 14 contracts as shown in FIG. 4 (ii), and then the intermediate
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`part B is pressed into the blood chamber 14 as shown in FIG. 4 (ii) and the blood chamber 14
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`further contracts, and finally, as shown in Fig. 4 (iii), the peripheral part A is pressed into the
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`blood chamber 14 and the blood chamber 14 comes to be in the maximum contracted state.
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`[0021]
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`On the other hand, when the blood chamber 14 is in the maximum contracted state as
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`shown in Fig. 4 (iii) and the negative pressure is applied to the diaphragm 20 by discharging
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`the air from the air chamber 15, as shown in FIG. 4 (ii), the intermediate part B is sucked into
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`the air chamber 15 starting from the peripheral part A, and then, as shown in FIG. 4 (i), the
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`center part C with the small stress of the diaphragm 20 is sucked into the air chamber 15, and
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`the blood chamber 14 comes to be in the maximum inflated state.
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`[0022]
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`As is apparent from the fact that the blood chamber 14 exhibits such contraction and
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`inflation movement by the diaphragm 20, only a small negative pressure is required to suck
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`the center part C of the diaphragm 20 being a thin film upon inflating the diaphragm 20, thus
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`the introduction of blood into the blood chamber 14 becomes easier, and in addition, the risk
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`of hemolysis is reduced since the blood is introduced into the blood chamber 14 at moderate
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`pace. Furthermore, the diaphragm 20 has the film thickness gradient in which it becomes
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`thinner toward the center part, the pulsation movement of the diaphragm 20 is made constant
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`at all times, and the blood flow state becomes stable in the blood chamber 14. As a result,
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`the anti-coagulant performance would not decrease and the local stress being accumulated in
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`the diaphragm 20 would not occur, so the durability can significantly be improved.
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`[0023]
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`Next, specific experiment example and comparative example using the blood pump
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`of the present invention will be described.
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`[0024]
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`Example 1
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`With the blood pump of the present invention obtained as described above, a
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`performance test was carried out using a water simulated circuit. The film thickness of the
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`diaphragm in the blood pump was measured, and the results shown in Table 1 were obtained.
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`As a result of the performance test with the water simulated circuit, a driving condition for
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`obtaining a pumping amount of 6.0 l/min by a pulsation number of 100 times/min was
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`driving positive pressure of 150 mmHg, driving negative pressure of -40 mmHg, and
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`contraction rate of 38%.
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`[0025]
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`A blood pump having a diaphragm with similar film thickness gradient as the
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`diaphragm in this blood pump was attached to a mature goat, the device was driven for 1
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`month under the above driving condition, and blood clots or hemolysis was not recognized in
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`the blood, and the blood pump was driven in safely in good condition.
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`[0026]
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`Example 2
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`A performance test was carried out with the blood pump of the present invention,
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`using a water simulated circuit similar to the Example 1. The film thickness of the
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`diaphragm in the blood pump was measured, and the results were as shown in Table 1. As a
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`result of the performance test, the driving condition for obtaining the pumping amount of 6.0
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`l/min by the pulsation number of 100 times/min was driving positive pressure of 220 mmHg,
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`driving negative pressure of -50 mmHg, and contraction rate of 36%. A blood pump having
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`a diaphragm with similar film thickness gradient as the diaphragm in this blood pump was
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`attached to a mature goat, the device was driven for 1 month under the above driving
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`condition, and blood clots or hemolysis was not recognized in the blood, and the blood pump
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`was driven in safely in good condition.
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`[0027]
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`Example 3
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`A performance test was carried out with the blood pump of the present invention,
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`using a water simulated circuit similar to the Example 1. The film thickness of the
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`diaphragm in the blood pump was measured, and the results were as shown in Table 1. As a
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`result of the performance test, the driving condition for obtaining the pumping amount of 6.0
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`l/min by the pulsation number of 100 times/min was driving positive pressure of 250 mmHg,
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`driving negative pressure of -60 mmHg, and contraction rate of 35%. A blood pump having
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`a diaphragm with similar film thickness gradient as the diaphragm in this blood pump was
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`attached to a mature goat, the device was driven for 1 month under the above driving
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`condition, and blood clots or hemolysis was not recognized in the blood, and the blood pump
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`was driven in safely in good condition.
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`[0028]
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`Comparative Example 1
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`
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`As shown in Table 1, a performance test was carried out with a blood pump provided
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`with a diaphragm having a substantially uniform film thickness, using a water simulated
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`circuit similar to the Example 1. As a result of the performance test, the driving condition
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`for obtaining the pumping amount of 6.0 l/min by the pulsation number of 100 times/min was
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`driving positive pressure of 220 mmHg, driving negative pressure of -100 mmHg, and
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`contraction rate of 45%. A blood pump having a diaphragm with similar film thickness as
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`the diaphragm in this blood pump was attached to a mature goat, the device was driven under
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`the above driving condition, hemolysis was recognized in the blood on the second day from
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`when the device started to be driven, and the hemolysis worsened on the third day which
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`required blood transfusion. However, the hemolysis tendency did not improve, so the
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`experiment was discontinued.
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`[0029]
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`Comparative Example 2
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`As shown in Table 1, a performance test was carried out with a blood pump provided
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`with a diaphragm having a substantially uniform film thickness, using a water simulated
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`circuit similar to the Example 1. As a result of the performance test, the blood pump was
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`driven at its substantially maximum driving condition, namely the pulsation number of 100
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`times/min, driving positive pressure of 300 mmHg, driving negative pressure of -100 mmHg,
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`and contraction rate of 50%, however the flow rate of 6.0 l/min could not be obtained.
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`When the pulsation number was set to 120 times/min, the flow rate of 6.0 l/min was obtained
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`under the driving condition of driving positive pressure of 280 mmHg, driving negative
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`pressure of -100 mmHg, and contraction rate of 42%.
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`Table 1
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`Peripheral Part (A) (mm)
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`Center Part (B) (mm)
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`Center Part (C) (mm)
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`Film Thickness Ratio to A (%)
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`Example 1
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`Example 2
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`Example 3
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`Comparative Example 1
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`Comparative Example 2
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`(Advantageous Effects of Invention)
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`[0030]
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`
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`As above, the blood pump of the present invention is configured to have the
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`diaphragm that is thick at its peripheral part and becomes gradually thinner toward the center
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`part, so the driving negative pressure for the diaphragm upon inflating the blood chamber and
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`the driving positive pressure for the diaphragm upon contracting the blood chamber can be
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`reduced, and the necessary flow rate can easily be obtained. Further, since the diaphragm is
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`driven smoothly, the blood flow will not be deposited internally, thus the anti-coagulant
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`performance would not decrease. In addition, with the low driving negative pressure for the
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`diaphragm upon inflating the blood chamber, the blood can be introduced into the blood
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`pump at the moderate pace, and there is not risk of the occurrence of hemolysis.
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`4.
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`Brief Description of Drawings
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`[0031]
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`
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`FIG. 1 is a cross sectional diagram showing an example of a blood pump of the
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`present invention, FIG. 2 is a cross sectional diagram for explaining an operation thereof, FIG.
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`3 is an explanatory diagram of a film thickness gradient of a diaphragm, and FIG. 4 (i) to (iii)
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`are cross sectional diagrams for explaining an operation of the diaphragm.
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`10 … Housing, 11 … Main Body Part, 12 … Back Plate Part, 14 … Blood Chamber,
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`15 … Air Chamber, 20 … Diaphragm
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`Agent: Patent Attorney Shusaku YAMAMOTO
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`End
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`Figure 1
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`Figure 3
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`Figure 2
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`Figure 4
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` (a)
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`(b)
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`(c)
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`TRANSLATOR'S DECLARATION
`
`I, Yuichi KAWASHIMA of Honyaku Center Inc. residing at Mita MT
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`Bldg. 7F, 3-13-12 Mita, Minato—ku, Tokyo, 108-0073 Japan, am
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`a Japanese language translator with over five years of
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`experience translating technical,
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`legal, and business
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`documents from Japanese to English and from English to Japanese.
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`Being fluent in both the Japanese and English languages,
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`I
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`certify under penalty of perjury under the laws of the United
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`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. 564-29267. 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. Thisdeclaratidnwasmadewithknowledgethatwillfulfalse
`
`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:
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`February 3, 2016
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`Translator Name:
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`Yuichi KAWASHIMA
`
`000015
`
`Nipro Ex. 1021
`
`Nipro Ex. 1021
`
`000015