Japan Patent Office
`
`Patent Laying-Open Gazette
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`Patent Laying-Open No.:
`
`2001-353215
`
`Laying-Open Date:
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`December 25, 2001
`
`Int.Cl.7:
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`A61M 1/14, 5/168
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`Identifying Mark:
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`595
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`FI:
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`A61M 1/14, 5/14
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`Theme Code (Reference):
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`595 4C066, 417 4C077
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`Request for Examination:
`
`Not Requested
`
`Number of Claims:
`
`Filing Form:
`
`(7 pages in total)
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`3
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`OL
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`Patent Application No.:
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`2000-176321
`
`Filing Date:
`
`June 13, 2000
`
`Applicant:
`
`
`Inventor:
`
`
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`Nikkiso Co., Ltd. (000226242)
`43-2, Ebisu 3-chome,
`Shibuya-ku, Tokyo
`Katsumi ISOU
`
`1
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`Nipro Ex. 1030
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`000001
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`
`
`Patent Laying-Open Gazette
`
`Patent Laying-Open No.:
`
`2001-353215
`
`Laying-Open Date:
`
`December 25, 2001
`
`Int.Cl.7:
`
`A61M 1/14, 5/168
`
`Identifying Mark:
`
`595
`
`FI:
`
`A61M 1/14, 5/14
`
`Theme Code (Reference):
`
`595 4C066, 417 4C077
`
`Request for Examination:
`
`Not Requested
`
`Number of Claims:
`
`Filing Form:
`
`(7 pages in total)
`
`3
`
`OL
`
`Patent Application No.:
`
`2000-176321
`
`Filing Date:
`
`June 13, 2000
`
`Applicant:
`
`
`Inventor:
`
`
`
`Nikkiso Co., Ltd. (000226242)
`43-2, Ebisu 3-chome,
`Shibuya-ku, Tokyo
`Katsumi ISOU
`
`1
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`Nipro Ex. 1030
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`000001
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`Inventor:
`
`
`
`
`Agent:
`
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`c/o Nikkiso Co., Ltd.
`Shizuoka Plant
`Shizutani 498-1, Haibara-cho,
`Haibara-gun, Shizuoka
`Sumio Ohara
`c/o Nikkiso Co., Ltd.
`Shizuoka Plant
`Shizutani 498-1, Haibara-cho,
`Haibara-gun, Shizuoka
`Patent Attorney
`Takao KOSHIKAWA (100095614)
`
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`[Title of the Invention] CLAMPING DEVICE FOR MEDICAL FLEXIBLE
`TUBE
`[Abstract]
`[Object] Provided is a clamping device for a medical flexible
`tube that can prevent a widthwise displacement of one end
`portion in clamping while maintaining a clamping workability,
`and can block a fluid flow without carefully performing a
`clamping work.
`[Solution Means] A clamping device 11 for a medical flexible
`tube includes an end portion 12 with a first convex portion 13
`formed therein, the other end portion 14 with a second convex
`portion 15 formed therein, a middle portion 16 that is
`continuous with the end portion 12 and the other end portion
`14, and a stopper 17 with which the end portion 12 is engaged,
`wherein a projection 12a is provided for guiding the one end
`portion 12 to the stopper 17.
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`[Claims]
`[Claim 1] A clamping device for a medical flexible tube,
`comprising:
`
`one end portion in which a first convex portion is formed;
`
`the other end portion in which a second convex portion
`opposed to the first convex portion is formed;
`
`a middle portion that is continuous with the one end
`portion and the other end portion;
`
`an engaging portion that is formed in the other end portion
`and with which the one end portion is engaged; and
`
`insertion holes that are formed in the other end portion
`and the middle portion, allowing a flexible tube to be inserted
`therethrough, wherein
`
`when the middle portion is bent to engage the one end
`portion with the engaging portion, the first convex portion and
`the second convex portion come close to each other to clamp the
`flexible tube inserted through the two insertion holes, thereby
`blocking a fluid flow there, characterized in that
`
`a guide portion is provided for guiding the one end portion
`to the engaging portion.
`[Claim 2] The clamping device for a medical flexible tube
`according to claim 1, characterized in that the guide portion
`includes projections that protrude from both ends at a tip of
`the one end portion, and the other end portion is inserted
`between the projections.
`
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`[Claim 3] The clamping device for a medical flexible tube
`according to claim 1, characterized in that the guide portion
`is a guide hole formed in the one end portion, and the other
`end portion is inserted through the guide hole.
`[Detailed Description of Invention]
`[0001]
`[Technical Field of the Invention]
`
`The present invention relates to a claiming device for
`a medical flexible tube that clamps a medical flexible tube
`forming an extracorporeal circulation circuit such as a blood
`circuit, an auxiliary circuit, an infusion circuit, or the like
`to block a fluid flow at that portion.
`[0002]
`[Prior Art]
`
`In general, a blood circuit in a dialysis device or the
`like is mainly formed by a flexible tube allowing patient’s
`blood, a physiological saline solution, a drug to be
`administered, or the like to flow therein in medical sites, and
`connects components such as a dialyzer and a chamber, with each
`other. As shown in Fig. 4, conventionally, a clamping device
`for blocking this flexible tube at a desired portion mainly
`includes one end portion 102, the other end portion 104 in which
`an insertion hole 104a and a stopper 107 are formed, and a middle
`portion 106 in which an insertion hole 106a is formed.
`[0003]
`
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`Further, a convex portion 103 and a convex portion 105
`
`are respectively formed in the end portion 102 and the other
`end portion 104 of the aforementioned clamping device 101 to
`be opposed to each other in such a manner that when the middle
`portion 106 is bent to engage the end portion 102 with the stopper
`107 of the other end portion 104, the convex portions 103 and
`105 clamp a flexible tube T inserted through the insertion holes
`104a and 106a to thereby block a fluid flow at that portion.
`[0004]
`[Problems to be Solved by the Invention]
`
`However, the aforementioned conventional clamping device
`has a problem that in a case where an application of a force
`to the end side 102 by a user (a clamping direction) is not
`appropriate when the end portion 102 is engaged with the stopper
`107, the end portion 102 may be engaged while being displaced
`in a widthwise direction with respect to the other end portion
`104. The engagement of the end portion 102 with displacement
`may cause incomplete blocking of the flexible tube T. Thus,
`it is necessary to do work carefully. In other words, in a case
`of proper clamping, approximately complete blocking is achieved
`at a clamped portion of the flexible tube T, as shown in Fig.
`5. However, in a case of clamping with displacement as
`mentioned above, the clamped portion of the flexible tube T may
`be left partly opened, as shown in Fig. 6, resulting in
`incomplete blocking.
`
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`[0005]
`
`In particular, prompt works are required in medical sites
`or the like in many cases. Therefore, a careful and proper work
`in the operation of the clamping device is an important issue
`in the medical sites requiring prompt works.
`[0006]
`
`The present invention has been made in view of these
`circumstances, and is to provide a clamping device for a medical
`flexible tube that can prevent a widthwise displacement of an
`end portion in clamping while maintaining a function of the
`clamping device, and can block a fluid flow without carefully
`performing a clamping work.
`[0007]
`[Means for Solving the Problems]
`
`The invention recited in claim 1 is characterized in that
`a clamping device for a medical flexible tube includes: one end
`portion with a first convex portion formed therein; the other
`end portion with a second convex portion formed to be opposed
`to the first convex portion; and a middle portion continuous
`with the one end portion and the other end portion; an engaging
`portion which is formed in the other end portion and with which
`the one end portion is engaged; and insertion holes formed in
`the other end portion and the middle portion to allow a flexible
`tube to be inserted therethrough, wherein, when the middle
`portion is bent to engage the one end portion with the engaging
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`portion, the first convex portion and the second convex portion
`come close to each other to clamp the flexible tube inserted
`through the two insertion holes and block a fluid flow there,
`and a guide portion is provided for guiding the one end portion
`to the engaging portion.
`[0008]
`
`With this arrangement, when the one end portion is
`intended to be engaged with the engaging portion for clamping
`the flexible tube, the one end portion is guided by the guide
`portion to reach the engaging portion and then engaged there.
`The guide portion may be provided in any of the one end portion,
`the other end portion, and the middle portion.
`[0009]
`
`The invention recited in claim 2 is characterized in that
`the guide portion includes projections that protrude from both
`ends of a tip of the one end portion, and the other end portion
`is inserted between the projections.
`[0010]
`
`With this arrangement, when the one end portion is engaged
`with the engaging portion in order to clamp the flexible tube,
`the one end portion reaches the engaging portion while the
`widthwise movement thereof is restricted by the projections,
`and is then engaged there.
`[0011]
`
`The invention recited in claim 3 is characterized in that
`
`
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`the guide portion is a guide hole formed in the one end portion
`and the other end portion is inserted through the guide hole.
`[0012]
`
`With this arrangement, when the one end portion is engaged
`with the engaging portion for clamping the flexible tube, the
`one end portion reaches the engaging portion while its widthwise
`movement is restricted by both side surfaces forming the
`aforementioned guide hole, and is then engaged there.
`[0013]
`[Embodiments of the Invention]
`
`Embodiments of the present invention will be specifically
`described below with reference to the accompanying drawings.
`A clamping device for a medical flexible tube in a first
`embodiment according to the present invention is applied to a
`blood circuit 1 shown in Fig. 1, for example. This blood circuit
`1 extracorporeally circulates a patient’s blood for a dialysis
`treatment so that an infusion (this is to supply a physiological
`saline solution in priming, but supply of a mixture of infusion
`solutions may be also performed as appropriate for some patients
`undergoing dialysis), a blood transfusion (performed as
`appropriate for some patients undergoing dialysis), blood
`purification, or the like is performed for the patient’s blood
`during circulation.
`[0014]
`
`The blood circuit 1 shown in Fig. 1 mainly includes a
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`plurality of flexible tubes a to f, indwelling-needle
`connection connectors 2 and 3 respectively fixed to the tips
`of the flexible tubes a and f, a flexible tube 4a with which
`a blood pump 4 comes into contact, drip chambers 5 and 6, tubes
`g and h connected for forming an infusion line, and an infusion
`chamber 8. A dialyzer 7 that is a blood purifier is provided
`between the flexible tubes d and e.
`[0015]
`
`The indwelling-needle connection connector 2 has its tip
`connected to an indwelling needle, and is adapted to collect
`blood by puncturing the patient’s artery with the indwelling
`needle. The collected blood is purified by passing through
`components including the dialyzer 7 provided in the downstream
`of the connector 2, and is returned to a body from an indwelling
`needle connected to the tip of the indwelling-needle connection
`connector 3 and inserted into a patient’s vein.
`[0016]
`
`A pipe tee 9 is connected to the downstream tip of the
`flexible tube a. To this pipe tee 9, the flexible tube b and
`the flexible tube g of the infusion line are also connected in
`addition to the flexible tube a. A flexible tube 4a having a
`relatively large diameter is arranged and connected between the
`flexible tubes b and c. The blood pump 4 rotates while squeezing
`this flexible tube 4a, to circulate the blood introduced into
`the blood circuit 1 from the side of the indwelling-needle
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`connection connector 2 to the side of the indwelling-needle
`connection connector 3.
`[0017]
`
`The drip chambers 5 and 6 are provided between the flexible
`tubes c and d and between the flexible tubes e and f,
`respectively. With these drip chambers 5 and 6, air bubbles
`in the blood circuit 1 are removed. Alternatively, the blood
`circuit may be configured without the drip chamber 5, so that
`only the drip chamber 6 is provided between the flexible
`flexible tubes e and f.
`[0018]
`
`The dialyzer 7 is provided between the flexible tubes d
`and e and purifies the blood flowing in the blood circuit 1.
`For example, a hollow fiber blood purifier can be considered
`as the dialyzer 7 that can be applied. This hollow fiber blood
`purifier allows a blood to pass through a hollow fiber membrane
`arranged therein while allowing a dialysate introduced via a
`dialysate inlet 7a to pass between the outside of the hollow
`fiber membrane and a main body (a housing) of the purifier and
`be discharged via a dialysate outlet 7b. This hollow fiber
`blood purifier performs removal of extra water in the body,
`adjustment of electrolytes, removal of uremic toxins, and the
`like.
`[0019]
`
`Meanwhile, an infusion chamber 8 is provided at another
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`end of the flexible tube g connected to the pipe tee 9, and is
`configured to stabilize bubbles in the infusion or the blood
`in an infusion container 10 connected thereto via the flexible
`tube h and a connecting portion 10a before the infusion or the
`blood is introduced into a path formed by the flexible tubes
`a to f. These flexible tubes g and h and the infusion chamber
`8 form the infusion line.
`[0020]
`
`Further, a flexible tube i forming an anticoagulant
`supply line is connected to the flexible tube c between the
`flexible tube 4a and the drip chamber 5 via a pipe tee 19, and
`is configured to infuse a drug for preventing blood coagulation
`from a supply unit connected to a connector 18 at its tip.
`[0021]
`
`Flexible tubes j and l, having connectors 20 and 21 at
`tips, respectively, and forming a level adjustment line, are
`connected to the tips of the drip chambers 5 and 6, respectively.
`With this line, the liquid surfaces in the drip chambers 5 and
`6 are adjusted to arbitrary positions. Furthermore, a tube k
`is connected to the top end of the drip chamber 6, which has
`at its tip a connector 22 connected to a pressure monitor
`mechanism of a dialysis device and forms a pressure monitor
`line. With this line, the pressure in the blood circuit 1 is
`monitored.
`[0022]
`
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`The clamping device as the first embodiment according to
`
`the present invention is attached to a desired portion of the
`aforementioned flexible tubes a to h, and clamps the flexible
`tubes a to l to block the blood, the physiological saline
`solution, or the drug such as the infusion and the
`anticoagulant, flowing in the flexible tubes a to l. Although
`a case of clamping the flexible tube a is mentioned below, the
`flexible tube to be clamped may be other flexible tubes b to
`l.
`[0023]
`
`In this clamping device for a medical flexible tube,
`components shown in Fig. 1 are integrally molded from resin.
`The appearance of the clamping device is mainly formed by one
`end portion 12 with the first convex portion 13 formed therein,
`the other end portion 14 with the second convex portion 15 formed
`therein, and a middle portion 16. The material for the clamping
`device 11 is polypropylene. However, it may be formed of
`another material (another olefin based resin, polyacetal,
`polyethylene, or the like).
`[0024]
`
`The end portion 12 has the first convex portion 13 that
`is convex and formed to project downward from the inner surface
`(the lower surface) thereof. The end portion 12 is designed
`in such a manner that the widthwise dimension n thereof on the
`tip side is larger than the widthwise dimension n of the other
`
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`end portion 14, as shown in Fig. 1(a). Projections 12a as guide
`portions are molded to project from both ends of the tip of the
`end portion 12, respectively.
`[0025]
`
`The dimension of the gap between the projections 12a is
`designed to be slightly larger than the(cid:3)widthwise dimension n
`of the other end portion 14 and is formed to allow the other
`end portion 14 to be inserted and pass between the projections
`12a. With this configuration, when the end portion 12 moves
`downward in Fig. 1(b), the(cid:3)widthwise movement of the end portion
`12 is restricted.
`[0026]
`
`The other end portion 14 is formed from a portion 14b that
`extends approximately horizontally to a portion 14c standing
`from the portion 14b toward the end portion 12, as shown in Fig.
`1(b). In the portion 14b, the second convex portion 15 is formed
`to project upward from the inner surface (the upper surface)
`of the portion 14b to be opposed to the first convex portion
`13. The second convex portion 15 is formed to have an arc cross
`section at its tip end like the first convex portion 13, and
`is configured such that a shear force is not applied to the
`flexible tube a when the flexible tube a is clamped.
`[0027]
`
`In the portion 14c of the other end portion 14, an
`insertion hole 14a is formed which allows the flexible tube a
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`to be inserted therethrough. Also, a stopper 17 as an engaging
`portion is formed on the tip side of the portion 14c. This
`stopper 17 is a portion with which the end portion 12 is engaged.
`The tip of the end portion 12 comes into contact with a step
`17a formed inside the stopper 17 (the left side in Fig. 1(b)),
`so that the stopper 17 restricts the upward movement of the end
`portion 12 with elasticity of the middle portion 16 and engages
`with the end portion 12.
`[0028]
`
`The middle portion 16 is formed to be continuous with the
`end portion 12 and the other end portion 14. An insertion hole
`16a formed at a position opposed to the insertion hole 14a formed
`in the other end portion 14 to allow the flexible tube a to be
`inserted therethrough. The middle portion 16 is configured to
`be bent such that the end portion 12 comes close to the other
`end portion 14 when a force F for clamping is applied to the
`end portion 12.
`[0029]
`
`An operation by the aforementioned clamping device 11
`will be described below. The flexible tube a that needs to be
`clamped is inserted through the insertion holes 14a and 16a in
`advance. When the necessity of blocking a fluid flowing in the
`flexible tube a arises, a user applies the force F to the end
`portion 12 with a fingertip to bend the middle portion 16 and
`move the end portion 12 towards the other end portion 14.
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`[0030]
`Since the other end portion 14 is inserted between the
`projections 12a at that time, the end portion 12 is properly
`guided in the longitudinal direction of the other end portion
`14, and the tip of the end portion 12 is guided to the stopper
`17. That is, the widthwise movement of the end portion 12 is
`restricted by the other end portion 14 while the movement of
`the end portion 12 towards the other end portion 14 is permitted.
`Thus, until the tip of the end portion 12 reaches the stopper
`17, the widthwise displacement of the end portion 12 can be
`prevented and therefore engagement is achieved at a proper
`position.
`[0031]
`
`According to the present embodiment, it is possible to
`prevent the displacement of the end portion 12 in engagement
`only by providing the projections 12a in the end portion 12.
`Therefore, the reliability of the clamping device can be
`improved, and the increase in the manufacturing cost in
`association therewith can be suppressed to a lower level.
`[0032]
`
`A clamping device for a medical flexible tube in a second
`embodiment according to the present invention will be described
`below. Note that the same components as those in the first
`embodiment are labeled with the same reference characters. As
`shown in Fig. 2, the clamping device according to the present
`
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`embodiment has an appearance mainly formed by an end portion
`12’ with the first convex portion 13 formed therein, the other
`end portion 14 with the second convex portion 15 formed therein,
`and the middle portion 16. These components are integrally
`molded from resin, as in the first embodiment. The material
`of this clamping device 11’ is the same as that in the first
`embodiment.
`[0033]
`
`The clamping device 11’ in the present embodiment has a
`guide hole 12’a as a guide portion approximately at the center
`on the tip side of the end portion 12’. The guide hole 12’a
`is formed as a rectangular opening having the vertical dimension
`o and the horizontal dimension q. The dimension o is slightly
`larger than the widthwise dimension n of the stopper 17, and
`the dimension q is slightly larger than the thickness dimension
`p of the stopper 17.
`[0034]
`Since the guide hole 12’a is configured to allow the tip
`of the other end portion 14 to be inserted therethrough, the
`end portion 12’ is properly guided in the longitudinal direction
`of the other end portion 14, and the tip of the end portion 12’
`is guided to the stopper 17. That is, the widthwise movement
`of the end portion 12’ is restricted by the other end portion
`14 while the movement of the end portion 12’ towards the other
`end portion 14 is permitted. Thus, the widthwise displacement
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`of the end portion 12’ can be prevented until the tip of the
`end portion 12’ reaches the stopper 17, and therefore engagement
`is achieved at a proper position.
`[0035]
`
`According to the present embodiment, in addition to
`restriction of the movement of the end portion 12’ in the
`widthwise direction of the other end portion 14, the movement
`in the thickness direction of the end portion 14 can be also
`restricted. Thus, the tip of the end portion 12’ can be guided
`to the stopper 17 more properly. The step 17a in the stopper
`17 may be formed to face the opposite side by 180 degrees (that
`is, face the right side in Fig. 1(b). In this case, the clamping
`function as the clamping device 11 is the same as that shown
`in Fig. 1(b).
`[0036]
`
`Although the present embodiment is mentioned above, the
`present invention is not limited thereto. For example, the
`guide portions for guiding the end portion to the stopper (the
`engaging portion) may be provided in the first convex portion
`and the second convex portion, or may be provided in other
`portions. Also, the shape of the guide hole is not limited to
`a rectangular shape, but may be another shape (e.g., an
`elliptical shape or a different shape), as long as it has a size
`allowing the other end portion 4 to be inserted therethrough.
`[0037]
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`Further, although the clamping device is mentioned as
`
`being applied to the blood circuit 1 in the present embodiment,
`the clamping device may be applied to another extracorporeal
`circulation circuit or an auxiliary circuit, an infusion line,
`an anticoagulant supply line, a level adjustment line, a
`pressure monitor line, or the like. Also, the material of the
`clamping device is not limited to the resin already mentioned.
`The clamping device may be formed of another material, as long
`as the clamping device can be configured such that the middle
`portion can be bent to engage the tip of the end portion with
`the stopper (the engagement portion).
`[0038]
`[Effects of THE Invention]
`
`According to the invention of claim 1, the end portion
`is guided by the guide portion to be engaged with the engaging
`portion. Therefore, it is possible to prevent the widthwise
`displacement of the end portion in clamping while maintaining
`the clamping workability, and to improve the reliability of the
`clamping device.
`[0039]
`
`According to the invention of claim 2, it is possible to
`prevent the displacement when the end portion is engaged with
`the engaging portion only by providing projections in the end
`portion. Therefore, the increase in the manufacturing cost
`associated with the improvement of the reliability of the
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`clamping device can be suppressed to a lower level.
`[0040]
`
`According to the invention of claim 3, in addition to
`restriction of the movement of the end portion in the widthwise
`direction of the other end portion, the movement in the
`thickness direction of the other end portion is also restricted.
`Therefore, the tip of the end portion can be guided to the
`engaging portion more properly.
`[Brief Description of the Drawings]
`Fig. 1(a) is a plan view showing a clamping device for
`a medical flexible tube in the first embodiment according to
`the present invention, Fig. 1(b) is a front view of the same,
`and Fig. 1(c) is a left side view of the same.
`Fig. 2(a) is a plan view showing a clamping device for
`medical flexible tube in the second embodiment according to the
`present invention, Fig. 2(b) is a front view of the same, and
`Fig. 2(c) is a left side view of the same.
`Fig. 3 schematically shows a blood circuit to which the
`present invention is applied.
`Fig. 4(a) is a plan view showing a conventional clamping
`device for medical flexible tube, Fig. 4(b) is a front view of
`the same, and Fig. 4(c) is a left side view of the same.
`Fig. 5 schematically shows a cross section in a clamped
`portion of a flexible tube in a case of proper clamping by the
`conventional medical flexible tube.
`
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`Fig. 6 schematically shows the cross section in the
`clamped portion of the flexible tube in a case where clamping
`is performed by the conventional medical flexible tube while
`a displacement occurs.
`[Description of Reference Numerals]
`1: Blood circuit
`2, 3: Indwelling-needle connection connector
`4: Blood pump
`5, 6: Drip chamber
`7: Dialyzer
`8: Infusion chamber
`9: Pipe tee
`10: Infusion container
`10a: Connecting portion
`11, 11’, 101: Clamping device
`12, 12’, 102: End portion
`12a: Projection
`12’a: Guide hole
`13: First convex portion
`14, 104: Another end portion
`14a, 16a, 104a, 106a: Insertion hole
`15: Second convex portion
`16, 106: Middle portion
`17, 107: Stopper (engaging portion)
`17a: Step
`
`
`
`21
`
`Nipro Ex. 1030
`
`000021
`
`
`
`18, 20 to 22: Connector
`103, 105: Convex portion
`a to l, 4a, T: Flexible tube
`
` Fig.5 Fig.6
`
`
`
`22
`
`Nipro Ex. 1030
`
`000022
`
`
`
` Fig.1 Fig.2
`
`
`
`23
`
`Nipro Ex. 1030
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`000023
`
`
`
` Fig.3 Fig.4
`
`
`
`24
`
`Nipro Ex. 1030
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`000024
`
`
`
`TRANSLATOR’S DECLARATION
`
`I,TatsuoHARA<flfHARAPatentTranslationresidingat]Jr53-201,
`Minoh 2—chome, Minoh—shi, Osaka, Japan, anma Japanese language
`
`translator with over.twenty five years of experience
`
`translating technical,
`
`legal, and business documents from
`
`Japanese113Englisrxand.fron1Englisk1to Japanese. Being fluent
`
`in both the Japanese and English languages,
`
`I certify under
`
`penalty of perjury under the laws of the United States that:
`
`1.
`
`To the best of my knowledge and belief,
`
`the preceding
`
`document is a true and correct English translation of Japanese
`
`Patent Publication No. 2001-353215;
`
`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:
`
`3
`
`Tatsuo HARA
`
`000025
`
`Nipro EX. 1030
`
`Nipro Ex. 1030
`
`000025
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