AU648600B2 - Blood processing apparatus of hollow fiber type - Google Patents

Description

6 486G

AUSTRALIA

Patents Act 1990 p/00/0011 Regulation 3.2 COMPLETE SPECIFICATION FOR A STANDARD PATENT

ORIGINAL

0 0 0*C0 0 00 Name of Applicant: Actual Inventor(s): TERUMO KABUSHIKI KAISHA KAZUHIKI HAGIWARA .0.00* 0*0* 0 *0 0 *000 0 0.0.

00000 0 0*0 0 00 0.

0 0 0 Address for service in Australia: CARTER SMITH BEADLE, Qantas House, 2 Railway Parade, Camberwell, Victoria, 3124, Australia, Attorney Code SA.

Invention Title: BLOOD PROCESSING APPARATUS OF HOLLOW FIBER TYPE The following statement is a full description of this invention, including the best method of performing it known to us: TITLE BLOOD PROCESSING APPARATUS OF HOLLOW FIBER TYPE BACKGROUND OF THE INVENTION This invention relates to a blood processing apparatus of hollow fiber type with a plurality of hollow fibers used for extracorporeal circulation of blood to effect dialysis, purification, gas exchange, etc. of blood.

This kind of hollow fiber type blood processing apparatus is extensively used as oxygenators and dialyzers. As an example, an oxygenator apparatus Lo as shown in Fig. 1 is well known as a help (ECMO Extracorporeal Membrane Oxygenation) to an organic

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lung by extracorporeal circulation. This structure will now be described briefly.

Reference numeral 1 designates hollow fiber bundle 15 iaving a plurality of hollow fibers, through which blood flows. This hollow fiber bundle 1 has its go** opposite ends embeddedly secured to and supported by respective partitioning walls 2 which isolate liquid tight a blood processing chamber 3a and a blood port t o zones 4a to be described later from one another such that the hollow fibers are open to the zones 4a.

The periphery of hollow fiber bundle 1 is covered by a housing 3, 'while the opposite ends of the bundle 14- -2i are covered by a liquid port covers 4 which constitute part of housing 3. Housing 3 has a cylindrical body 5 and mount covers 6 fittedly mounted on the opposite ends of the cylindrical body 5. The mount covers 6 are held in close contact with the periphery of partitioning walls 2, thus forming blood processing chamber 3a in housing 3. Mount covers 6 are provided with gas ports 3b for supplying oxygen for gas exchange with blood. A flow path is formed in chamber 3a.

*Each port cover 4 defines inner conical blood port zone 4a flaring toward end face la of hollow fiber bundle 1, and it has blood port 4b provided at its free end and extending along axis X-X of the hollow fiber bundle and flange 7 provided at its flaring end. Blood port cover nut 8 having annular flange 8a is screwed on mount cover 6 of housing 3 such that annular flange 8a urges the outer surface of flange 7. Flange 7 is held in close contact via packing 9 with an edge portion of partitioning wall 2.

The oxygenator of this structure is of internal return flow type, and in which blood enters the hollow *fibers from one blood port 4b and through one blood port zone 4a, and as it passes through the hollow fibers carbon dioxide gas in it is exchanged through the hollow fibers with oxygen supplied to blood -3processing chamber 3a from one gas port 3b. Blood gaining oxygen is returned to the organism through other blood port zone 4a and other blood port 4b.

Carbon dioxide gas removed from blood is let to the outside from other gas port 3b.

In the above prior art oxygenator, the area of end surface la of hollow fiber bundle 1 is considerably large compared to the area of blood port 4b.

Therefore, the speed of blood flowing through blooQ port zone 4a is difficultly uniform. More specifically, the speed of blood flowing into or out of the hollow fibers is high in a central portion of end surface la right underneath or right above blood port 4b because the flow is led directly to or from port 4b, while it is low in edge portion of end surface la because the distance to the port is increased. Therefore, in blood port zone 4a at the see* edge of hollow fiber bundle the flow of blood is very low so that stagnant state results or, in some cases, o*oo 20 is completely stopped. In such a case, precipitation of blood cells is produced in a peripheral portion of hollow fiber bundle 1. If this occurs, it undesirably leads to formation of thrombus and further clogging of hollow fiber bundle 1.

Further, in the oxygenator of vertical type as shown in Fig. i, blood is caused to flow either -4downwardly from the upper blood port zone to the lower one or in the converse direction, upwardly.

The stagnation of blood in blood port zone 4a is produced pronouncedly in blood port zone 4a on the inlet side in the case of the downward flow and one on the outlet sine in the case of the upward flow due to the influence of the gravitational force, and solution of this problem is particularly desired.

To solve this problem, there have heretofore been proposed a structure, in which the peripheral wall of the liquid port zone has a curved surface based on a predetermined calculation, and a structure, which has a particular blood port zone shape such as revolving flow type. Examples of such structures 15 are disclosed in Japanese Patent Publications No.62-54510 and No.60-5308 and Japanese Patent Disclosure No.62-21107.

However, stagnation of blood can not be sufficiently prevented even with these proposed blood "f 20 processing apparatuses. More specifically, where downward blood flow is caused, stagnation of blood in a peripheral portion of hollow fiber bundle still can not be prevented with the apparatus, in which the peripheral surface of the inlet side blood port zone has a curved shape based on a predetermined calculation, while with the apparatus of the revolving 5 flow type it is produced in a central portion of the hollow fiber bundle although it is prevented in the peripheral portion.

Further, the proposed structures mainly aim the prevention of blood stagnation in the inlet side blood port zone which is particularly significant where downward blood flow is caused. That is, they neither aim nor provides for any expected effect of prevention of blood stagnation in the outlet side blood port zone which is particularly significant where upward blood flow is caused.

Particularly, with recent development of materials having compatibility to blood, non-heparin extracorporeal circulation without use of heparin 15 or like agent against coagulation of blood is being tried. In this case, the stagnation of blood causes clogging of the hollow fiber bundle and formation S" of thrombus, and it is fatal if extracorporeal circulation is performed for long time, thus posing significant quality and safety problems.

Further, in extracorporeal circulation using an oxygenator, it is usual in view of the arrangement of the blood circuit and priming operation and also in case of coupling a heat exchanger to the oxygenator to dispose the apparatus vertically for causing upward blood flow from the considerations of the safety of -6a heavy and large heat exchanger filled with water.

In such cases, therefore, the stagnation of blood in the outlet side blood port zone presents particular significant problems.

Further, where a centrifugal pump or like constant flow pump is used for upward blood flow, blood flow not pulsatingly but constantly, and therefore in the blood port zone blood stagnation is liable to be produced in the peripheral portion.

Further, this kind of blood processing apparatus has the following problems.

As blood processing apparatus where extracorporeal circulation is performed there are oxygenators and dialyzers, and for enhancing the effect of processing recirculating blood led out from the organism back to the blood processing apparatus is in considerable practice in therpautical processes, in which CO 2 in o* blood is removed by extracorporeal circulation. The .4 S recirculation is usually performed with a system as 20 shown in Fig. in which two reservoir R1 and •R2 and two pumps P1 and P2 are provided, or with a system as shown in Fig. in which only two pumps P1 and P2 are provided, no reservoir is provided, in the recirculation circuit.

With the system with the reservoirs, however, a great amount of blood is circulated. Extracorporeal -7circulation without use of any anti-coagulation agent is also tried to prevent bleeding when the apparatus is used continuously for long time. In this case, however, the system with the storage units can not be utilized because thrombus is formed in stagnated part of blood.

Further, even with the system without use of any storage unit extreme pressure variations are liable depending on the timing of operation of the two pumps, and increase of the amount of recirculation may produce a negative pressure in the outlet side blood port zone in the blood processing apparatus. This do-s 0 not only leads to rupture of blood cells, but if the .hollow fiber film is porous, the possibility of *b '15 introduction of air bubbles is increased, thus making it difficult to continue operation. Further, in the inlet side blood port zone an increase of the amount of recirculation may produce positive pressure, thus D* O leading to the rupture of blood cells.

20 In order to prevent this, it is tried to hold the pumps in a non-occulusive state. In this case, .0*4 however, reverse flow or idling is liable to be produced, making it difficult to grasp the amount of blood and also causing extreme damage to blood.

Besides, doing so is hardly ineffective in the prevention of negative pressure generation.

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too a *r *C 6 4 6 I as -8- SUMMARY OF THE INVENTION It is an object of the present invention to provide a blood processing apparatus, which, although with use of pumps in a perfectly occlusive state, for instance, roller pumps, can prevent generation of undesired pressure in the circuit, particularly generation of negative pressure or momentary abnormal pressure variations, thus permitting ready and safe blood processing by extracorporeal circulation.

The invention provides a blood processing apparatus of hollow fiber type characterized by comprising: a hollow fiber bundle having a large number of hollow fibers; a housing accommodating said hollow fiber bundle; a blood port provided on said housing; a blood port zone provided inside said housing and communicating with said blood port; and movable wall means for varying the volume of said blood port zone.

In a preferred structure of the blood processing apparatus of hollow fiber type according to the invention, movable wall means is provided, which can vary the volume of the blood port zone. The movable wall means is constituted by a movable member facing the. end surface of the hollow fiber bundle via the blood port zone and supported by the housing such that it is substantially parallel to the end surface of the hollow fiber bundle and movable in the axial direction thereof toward and away from the end surface. The movable member, which is circular in shape corresponds to the circular end surface of the hollow

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at tbspe.058/terumo.div 91 10 28 -9fiber bundle, has a central increased distance space projecting into the blood port zone toward the end surface of the hollow fiber bundle.

With this structure, provided with the movable member, it is possible to produce an adequate and positive turbulent flow of blood in the blood port zone, thus precluding stagnation in the blood port zone and obtaining satisfactory blood flow therein.

In a further preferred structure according to the invention, the movable wall means is constituted by an elastically deformable flexible membrane provided in the housing.

The flexible membrane can be deformed by externally applying pressure to it, and by so doing the same function as with the movable member noted above can be obtained. In addition, with the flexible membrane it is possible to absorb abnormal pressure variations such as negative or positive pressure generated in a blood circulation circuit during operation of two pumps in the circuit.

In a further preferred structure according to the invention, restricting means for restricting the deformation of the flexible membrane is provided. The restrictirng means is constituted by a netlike member, which is formed spherically on the inner wall surface of 20 the housing or stretched in the housing. With this restricting means it Sis possible to prevent excessive deformation of the flexible membrane and provide a safer and more durable apparatus.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a front view, partly broken away, showing a prior art tbspe.058/terumo.div 91 10 28 %o, a 20 S2 L 0 8 15 8 0I B 04 blood processing apparatus of hollow fiber type; Figure 2(a) is a circuit diagram showing an extracorporeal circulation circuit of a prior art blood processing apper atus with a recirculation circuit with reservoirs; Figure 2(b) is a circuit diagram showing an extracorporeal circulation circuit of a prior art blood processing apparatus with a recirculation circuit without any reservoir; Figure 3 is a fragmentary sectional view showing an oxygenator as first embodiment of the blood processing apparatus according to the invention; Figure 4 is a fragmentary sectional view showing an oxygenator as second embodiment of the blood processing apparatus according to the invention; Figure 5 is a fragmentary sectional view showing a modification of the third embodiment; Figure 6 is a fragmentary sectional view showing an oxygenator as fourth embodiment of the blood processing apparatus according to the invention; Figures 7 and 8 are fragmentary sectional views showing contrasts compared to the blood processing apparatus according to the invention; Figure 9 is a graph illustrating an interval of air supply to a pressure chamber; Figure 10(a) is a front view, partly broken away, showing an oxygenator as fourth embodiment of the blood processing apparatus tbspe.058/terumo.div 91 10 28 11 0** c~.

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according to the invention; Figure 10(b) is a plan view showing the same embodiment of the oxygenator; Figure 11(a) is a fragmentary gectional view showing an oxygenator as embodiment of the blood processing apparatus according to the invention; Figure 11(b) is a plan view showing the fifth embodiment of the oxygenator; Figure 12 is a circuit diagram showing a circuit used for tests; and Figure 13 is a front view, partly broken away, showing an oxygenator as sixth embodiment of the blood processing apparatus according to the invention.

DETAILED DESCRIPTION OF THlE PREFERRED EMNBODIIENTS Now, preferred embodiments of the blood processing apparatus of hollow fiber type according to the invention will be described conjunction with oxygenator with reference to Figs. 3 to 13.

An oxygenator according to a first embodiment of the invention will be described with reference to Fig. 3. Referring to the Figure, reference niuneral 30 designates cylindrical peripheral wall member constituting part of housing 3. Peripheral wall member 30 is screwed on mount cover 6 and axially projects from the periphery of partitioning wall 2. By its screwing on mount cover 6, it is held in close contact via packing 31 with edge portion of partitioning wall 2. Reference numeral tbspe.058/terumo.div 9 02 911025 Il 1 -12- 2 designates circular movable member provided on the inner side of peripheral wall member 30 such that it face )en end surface la of hollow fiber bundle 1. Member 32 is axially movable toward and away from end surface la as shown by arrows in parallel therewith. Its surface facing end surface la of hollow fiber bundle 1 is parallel to end surface 1 in its edge portion 32a and has a spherical projection projecting toward end surface la in its central portion. It co-operates with end surface la to serve as movable wall means for varying the volume of the blood port zone. Its edge portion 32a is held in slidable close contact via packing 33 with the inner periphery of peripheral wall member 32, and blood port zone 34 is formed on its inner side. Blood port zone 34 is communicated with blood port 35 extending radially with respect of axis X-X of hollow fiber bundle 1.

For the remainder of the structure, this embodiment is the same as the previous first embodiment.

With the oxygenator of this construction, movable member 32 as movable wall means can be moved by an external driver (not shown) back and forth in vertical directions via operating end 32c, that is, it is movable toward and away from end surface la of hollow fiber bundle 1 between a position shown by solid line and a position shown by phantom line as shown by arrows in Fig. 3. By repeatedly reciprocally 0 moving movable member 32 at a predetermined interval, a turbulent flow is produced in the blood flow positively with variations of the volume of blood port zone 34. Thus, it is possible to obtain smooth and positive flow of blood in the entire blood port zone and thus prevent tbspe.058/terumo.div 91 10 13stagnation of blood, and hence production of thrombus or clogging of hollow fibers.

Further, since movable membpr 32 has spherically projecting central portion 32b other than edge portion 32a, blood port zone 34 is on the blood inlet side, sufficiently increased blood flow can be obtained even in periphery Ig of hollow fiber bundle 1 where stagnation of blood is particularly liable, and also a central space of the zone where stagnation is liable due to revolving flow is reduced. It is thus possible to prevent stagnation of blood more effectively.

Now, an oxygenator as second embodiment of the invention will be described with reference to Fig. 4. Referring to the Figure, reference numeral 40 designates cap member constituting part of housing 3. Cap member 40 has end wall portion 40a facing hollow fiber bundle 1 and ooo. cylindrical peripheral wall portion 40b. Peripheral wall portion 40b is screwed on mount cover 6, and by this screwing cap member 40 is held in close contact with packing 41 with edge portion of partitioning wall 2. Reference numeral 42 designates flexible membrane provided inside cap member 40 and capable of being elastically deformed. Member 42 serves as movable wall means and fulfills the same function as movable member 32 in the preceding second embodiment. It vertically divides oo" the space in cap member 40 into two divisions, that is, it defines blood port zone 43 between it and end surface la of hollow fiber bundle 1 and pressure chamber 44 between it and end wall portion 40a. It is desirably made of silicone rubber, for instance.

Cap member 40 is provided with operating fluid port 46 tbspe.058/terumo.div 91 10 14 communicating with pressure chamber 44 for introducing air or like operating fluid into chamber 44, that is, pressurized operating air can be supplied externally to pressure chamber 44 through port 46. Blood port zone 43, communicates with blood port 45 extending in the radial direction of end surface la like blood port 35 in the second embodiment.

For the remainder of the structure, this embodiment is the same as first embodiment.

With the oxygenator of this structure, membrane 42 is reciprocally moved by elastic deformation like a diaphragm from the state shown by solid line to the state shown by phantom line as shown by arrows 00* ee 90 ae e 00 09 00** 0 *S tbspe.058/terumo.div 91 10 28 15 in Fig. 4 as the pressure in pressure chamber 44 is increased and reduced with pressurized air or like operating fluid introduced into and removed from chamber 44. In this way, stagnation of blood can be prevented.

A modification of the sscond embodiment will now be described with reference to Fig. 5. Parts like those in the second embodiment are designated by iike reference numerals.

In this instance, end wall portion 40a has spherically convex inner surface 47 projecting toward end surface la of hollow fiber bundle 1, and it serves as means for restricting the operation of membrane 42. That is, the deformation of membrane 42 is restricted :due to contact thereof with inner surface 47. Membrane 42 thus can be held such that its centil portion is closer to end surface la of hollow fiber bundle i than its edge portion. Thus, where blood port zone 43 is used for the blood inlet side with the deformation of membrane 42 restricted in the above way, blood port zone 43 can be held in desired shape at all time to secure sufficient blood flow in peripheral portion lb of hollow fiber bundle 1 and reduce central space of the zone where stagnation is liable to be caused by revolving flow, thus permitting further effective prevention of stagnation tbspe.058/terumo.div 9218 -16- *4 4***4 4 4 4 *4 *4*444 4 4** 20 4* 44 Sr of blood.

In the above modification, the end wall portion 40a is formed integrally with the cap member 40 constituting part of housing 3.

Alternatively the end wall portion 40a may be formed by a separate member different from the cap member 40 so as to have a spherical shape projecting toward the end surface la of the fiber bundle 1.

Now, an oxygenator as third embodiment of the invention will be described with reference to Fig. 6. This embodiment, uses a membrane, and parts like those in the second embodiment are designated by like reference numerals. Blood port 45 is provided on the center of end wall portion of cap member 40 and extends axially.

Membrane 42 is stretched in a curved fashion between the inner end of blood port 45 and outer side of the edge of hollow fiber bundle 1 such that it flares toward the bundle. It defines blood port zone 43 between it and end surface la of hollow fiber bundle 1 and pressure chamber 44 between it and end wall portion 40a. Operating pressure of air or like operating fluid can be externally introduced into pressure chamber 44 through operating fluid port 46. Operating pressure in pressure chamber 44 causes reciprocal movement by deformation of membrane 42 betweem the state shown by solid line and the state shown by phantom line as shown by arrows in the Figure, thus varying the volume of blood port zone 43. In this way, turbulence can be positively produced in blood flow in blood port zone 43 to provide for satisfactory flow of blood in an edge portion of zone 43 where stagnation is liable, providing for uniform flow of blood and preventing stagnation thereof.

tbspe.058/terumo.div 91 10 17- In the foregoind, the first to third embodiments and a modification has been described. While these embodiments and modification of the blood processing apparatus of hollow fiber type according to the invention concerns oxygenator, the invention is also applicable to other medical apparatus uses such as artificial kidneys and further to industrial fields other than the medical apparatus field.

To confirm the effectiveness of the oxygenators of the above embodiments, the inventor conducted the following experiments.

The method of covalent coupling of heparin to the hollow fibers and other members was the same as in Experiment 1.

More specifically, with Modified types 2E and 2F and Contrasts 9.

2G and 2H experiment of non-heparin extracorporeal circulation was conducted using dogs for observing the formation of thrombus and clogging of hollow fibers in the blood port zones. With Modified type 2F thrombus or clogging of hollow fibers in blood port zone was hardly recognized. With Modified type 2E only slight thrombus was recognized in an edge portion of central surface 27 on the inner side of annular fib 26a in blood port zone. With Contrast 2G thrombus and clogging of hollow fibers were observed very slightly on the side opposite blood port 25. With Contrast 2H thrombus w- -4 fbs.erved along the edge of hollow fier bundle 1, and hollow fibers in this portion were found to be clogged.

(Experiment 1) As the oxygenator according to the invention, Modified type 3A was produced from "Capiox II08" like Modified types 1A to 1C noted tbspe.058/terumo.div 91 10 18before by replacing one of blood port covers 4 with peripheral wall member 30 in the first embodiment shown in Fig. 3. Also, Modified type 3B was produced by replacing blood port cover 4 with cap member in the fourth embodiment shown in Fig. 4 of parent application No.

47383/89. Further Modified types 3C and 3D were produced by using cap member 40 in the modification of the second embodiment shown in Fig. 5 and cap member 40 in the fifth embodiment shown in Fig. 6, respectively. As membrane 42 was used a silicone rubber membrane with a thickness of 200 microns.

Further, Contrast 3E was produced by replacing blood port cover 4 with blood port cover 50 as shown in Fig. 7, defining blood port zone ,50a just line a blood port zone defined when membrane 42 shown in S Fig. 4 is parallel to the end surface of hollow fiber bundle 1. Further, Contrast 3F was produced by replacing blood port cover 4 with blood 55 port cover 60 as shown in Fig. 8, defining blood port zone 60a having the same shape as blood port zone that is defined when membrane 42 shown in Fig. 5 is closest to end surface la of hollow fiber bundle 1.

Further, "Capiox 1108" was used as Contrast 3G without modification.

For blood port covers 50 and 60 of Contrasts 3E and 3F polyurethane and acrylic resin were used.

With Modified types 3A to 3D and Contrasts 3E to 3G, retention of pigment was observed in the manner as described before in connection with Experiment 1 by setting these apparatuses such that peripheral tbspe.058/terumo.div 91 10 19 wall member 30, cap member 40 and blood port covers 50 and 60 were en the lower side, blood inlet side, and injecting pigment into the inlet side blood port zone.

With modified types 3B to 3D, when repeatedly supplying operating air pressure to pressure chamber 44 at an interval of seconds as shown in Fig. 9 for reducing pressure in pressure chamber 44, the rate of suction of air or like operating fluid is held within the rate of blood flow 200 ml/min. as in Experiment If the suction rate exceeds this value, the increase of the volume of blood port zone i 10 43 due to pressure reduction in pressure chamber 44 exceeds the .,oooi quantity of blood entering zone 43 to set a negative pressure in zone 43.

Besides, since the hollow fibers were porous, in blood processing chamber 3a blood in the hollow fibers and ambient air are in direct contact with each other, so that it is possible that ambient air is sucked into hollow fibers. Where the hollow fibers are made of a diffusive membrane, blood is never in direct contact with air, and hence the above hazardousness can be avoided.

Wash-out was equally satisfactory with Modified types 3A, 3C and 3D, then with Mcdified type 3B, and was considerably inferior with Contrasts 3E and 3F in the mentioned order. The retention of pigment in the blood port zone one minute after injection of pigment was as follows. Modified types 3A, 3C and 3D were transparent, while tbspe.058/terumo.div 92 1 8 20 Modified type 3B was colored very slightly. With Contrast 3E pigment remained in the central space, and with Contrast 3F it also remained, but to a less extent, in the central space. With contrast 3G, it was recognized along the edge.

Further, Modified type 3D was set in the experimental flow circuit such that cap member 40 is on the upper blood outlet side, and for comparison to Contrast 3G pigment was injected into the outlet side blood port zone, and retention of pigment in the outlet side blood port zone was observed.

10 With Contrast 3G pigment remained in edge portion even after one minute from the injection of pigment, but with Modified type 3D Futher, Modified type 3H was produced from "Capiox II08" by replacing both upper and lower blood port covers 4 with cap members 15 40 shown in Fig. 6 and using hollow fibers with covalently coupled o n heparin. Further, Contrast 31 was produced from "Capiox 108" by commonly coupling heparin to the hollow fibers. Heparin was commonly coupled in the same way as in Experiment 1.

With Modified type 3H and Contrast 31 experiment of nonheparin extracorporeal circulation was conduced using dogs in the manner as in Experiment 1.

With Contrast 31 the ozygenator was closed in 6 hours, whereas tbspe.058/terumo.div 92 1 8 21 with Modified type 3H the apparatus was hardly closed even after hours.

As has been shown, with the above embodiments and modifications thereof of the blood processing apparatus of hollow fiber type according to the invention, with the formation of the annular increased distance space provided along an edge portion of the hollow fiber bundle and small distance space defined inside the annular increased instance space, in the blood port zone, and or with the provision of the movable member in the blood port zone for varying the 10 volume thereof, it is possible to secure sufficient and uniform blood flow and proclude blood stagnation in the entire blood port zone including spaces adjacent to edge and central portions of the hollow 9 fiber bundle, thus preventing the formation of thrombus and clogging of hollow fibers.

Now, a fourth embodiment of the invention will be described with reference to Figs. 10(a) and This embodiment again is oxygenator 70 comprising cylindrical body 71 with opposite end portions 72a and 72b. Hollow fiber bundle 74 consisting of a large tbspe.058/terumo.div 9218 22 number of hollow fibers is secured at each end to partitioning wall 73a secured to the inside of each of end portions 72a and 72b such that it is open to blood port zone 75a. The periphery of blood port zone 75a is defined by peripheral wall member 76a secured to an end of end portion 72a. Blood inlet pipe 77 consisting one blood ductline is co- ected to peripheral wall member 77. Reference numeral designates flexible rubber membrane having a thickness of 100 microns. Membrane 80 can be readily deformed according to variations of pressure of blood in blood port zone 75a. Thus, when a pressure variation in blood port zone 75a. Thus, when a pressure variation 15 in blood port zone 75a is produced by blood flowing into zone 75a from inlet pipe 76a, flexible membrane 8 is deformed according to the pressure variation, thus maintaining stable pressure in blood port zone at all time. The edge of flexible membrane a' has its edge secured by bonding to the open end of -eripheral wall member 77, thus defining blood port zone 75a liquid tight. Over flexible membrane outside blood port zone 75a, net-like member 81 of a metal or a plastic material, constituting 25 restricting means for restricting the deformation of membrane 80, is secured to the open end of peripheral wall member 77 such as to clamp flexible 23 membrane 80 between it and member 77. As shown in net-like member 81 is spherically curved to be convex with respect to flexible membrane Thus, when flexible membrane 80 is deformed according to a blood pressure variation, particularly when blood port zone 75a is increased in volume due to excessive pressure, its excessive deformation can be restricted.

Further, since netlike member 81 is spherical in shape, flexible membrane 80 going to be deformed excessively is brought to uniform contact with the entire inner surface of member 81. Thus, restricting force is applied to flexible membrane 80 uniformly to avoid "b "damage to membrane As the other end hollow fiber bundle 74, like 0* 15 the above blood port zone, blood port zone 78 is formed, which is defined by peripheral wall member 72b and has a blood inlet port. Blood inlet pipe 76b as the other blood ductl4ne is communicated with this blood port zone. Inlet and outlet ports 79a 4 20 and 79b are provided for oxygen or like blood purifying medium.

Figs. 11(a) and 11 designate a fifth embodiment. In this embodiment of oxygenator like the preceding sixth embodiment, hollow fiber S 25 bundle 94 consisting of a large number of hollow fibers is secured at one end to partitioning wall 93a secured 24 to the inside of end portion 92a of cylindrical body 91 such that it is open to blood port zone 102a.

The periphery of blood port zone 102a is defined by peripheral wall member 92a. Reference numeral 103 designates flexible silicone rubber membrane with a thickness of 100 microns and having integral -ral blood inlet pipe 103a serving as one blood ductline.

When pressure variations are produced in blood port zone 102a, membrane 103 is deformed according to the pressure variation to maintain stable pressure in blood port zone 102a Et all time.

The edge of flexible membrane 103a is secured by bonding to the open end of peripheral wall member 92a, thus defining blood port zone 102a liquid tight.

Over flexible membrane 103, outside blood port zone 102a, restricting means for restricting the C Le deformation of membrane 103 is provided. The restricting means is constituted by net-like member 104 of polycarbonate. Member 104 has rim-like portion

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20 104a whicL is fittedly secured to the outer periphery of an end portion rf peripheral wall member 92a such that flexible membrane '03 is clamped between rim portion 104a and peripheral wall member 92a. Netlike member 104 has central hole 104b, through which blood pipe 103 extends. Net-like member 104, as shown in Fig. 11(a), is spherically curved such that it is convex with respect to flexible membrane. Thus, when flexible membrane 103 is deformed according to pressure variations of blood entering blood port zone 102a, its excessive deformation can be restricted particularly when blood port zone 102a is increased in volume due to excessive pressure increase.

At the other end of the hollow fiber bundle, like blood port zone 105 is defined by peripheral wall member 92b and has a blood inlet port secured thereto. Blood inlet pipe 103b as the other blood ductline is connected to the blood port and communicates with the blood port zone.

Fig. 13 shows an sixth embodiment of the

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invention. This embodiment is different from the 15 preceding sixth and seventh embodiments in the location of flexible membrane. More specifically, this embodiment of oxygenator 200 is an oxygenator of extracorporeal circulation type, in which blood is caused to flow on the outer side of the hollow fiber 20 bundle and oxygen gas on the inner side. Blood introduced from blood inlet pipe 217a passes through a space defined between the hollow fiber bundle and cylindrical body 216 to be led out through blood outlet pipe 217b. Cylindrical body 216 has opposite end increased diametrr portions 219 which are provided with fle-ible membranes 218 for buffering pressure I f 26 variations due to variations of blood flow. Again in this embodiment, a spherically curved net-like member like fifth and sixth embodiments may be provided in position corresponding to each flexible membrane 218 as restricting means for restricting t'ne deformation of membrane 218.

(Experiment 4) For comparing the performance of the fourtn to fifth embodiments of oxygenator (with membrane area of 3.3 m characteristics of these oxygenators were measured using a flow circuit shown in Fig. 12.

Contrast No. 4 was used for the fifth and sixth 0 embodiments, and Contrasts No. 5 and No. 6 for the eighth embodiment.

15 Referring to Fig. 12 designated at LT is liquid *000 tank, MP and BP main and bypass pumps, respectively, and P pressure sensor. As the pumps roller pumps were used. The oxygenators of the embodiments and contrasts were installed at the illustrated position to 20 of oxygenator in the circuit for measurement. With each oxygenator the minimum flow from bypass pump BP, with which bubbles from the oxygenator can be observed with the eyes, in each flow from main pump 00oo MP was measured.

0 In each measurement, liquid tank LT was filled with an aquaous solution with the viscosity thereof 27 adjusted to 3 centipoises with glycerine, and the minimum flow (1/min.) from bypass pump BP, with which bubbles are generated from the oxygenator, was measured with the flow from main pump MP set to 500, 600 and 700 ml/min. Table 2 shows the results. In Table 2, a represents the sixth embodiment, B the fifth embodiment, C.Contrast No. 4, D the sixth embodiment, and E Contrast No. As is obvious from Table 2, with either embodiment A or B of the oxygenator according to the invention, no bubbles were generated even with the permissible maximum flow in the oxygenator. In contrast, with the prior art oxygenator bubbles were generated with S oo*o a comparatively low flow rate. It was thus recognized 15 that according to the invention, unlike the prior art, bubbles are difficultly generated even when the oxygenator is set in a circuit having two pumps pumps MP and BP).

In each test, pressure at point P was measured, 20 and the minimum flow from BP, at which momentary negative pressure was generated, was measured. The results of measurements are shown in Table 3.

From this result, it was confirmed that with the embodiments according to the invention it is S* *S 25 possible to prevent generation of negative pressure.

While flexible membranes 80 and 103 in above t* f 28 Table 2 Minimum flow from BP, with which bubbles are generated 1 min Flow from MP A B C D E (ml/min) 500 3.5< 3.5< 2.0 5.5< 600 3.4< 3.4< 2.5 5.4< 700 3.3< 3.3< 3.0 5.3< *The minimum clinical flow with the oxygenator according to the invention was 4 1/min, and no greater flow was studied for A and B. Likewise, no greater flow was studied for D, the maximum flow of which was 6.0 1/min.

Table 3 *0 0 0 0 *0 0 0000 *0 *o 0 00 .20 f ***000 *0 •oe2 0 5 0o6 25 0 0 Minimum flow from BP when momentary negative pressure is generated 1 min Flow from MP A B C D E (ml/min) 0 4< 4< 0.3 6.0< 0.3 150 3.85< 3.85< 0.6 5.85< 0.6 300 3.7< 3.7< 0.6 5.7< 0.6 600 3.4< 3.4< 0.6 5.4< 0.6 29 embodiments are provided in both the inlet and outlet side blood port zones, it is possible to provide a membrane only in the outlet side blood port zone in order to prevent momentary negative pressure for preventing introduction of bubbles. To prevent momentary pressure increase and negative pressure, it is desirable to provide a membrane for each of the inlet and outlet blood ports. Further, various other changes and modifications of the above embodiments are possible without departing from the scope of the invention.

As has been described in the foregoing, with a the above fourth to fifth embodiments of the blood processing apparatus according to the invention, at s 0 15 least part of the blood flow path is constituted by a flexible membrane deformable according to blood pressure variations. Thus, it is possible to absorb pressure variations. In addition, there is no hazardousness of rupture of blood cells due to generation of negative pressure in the blood flow path. Further, there is no possibility of introduction of bubbles into the hollow fiber bundle.

Thus, the blood processing apparatus according to the invention permits ready re-circulation of blood without any storage unit, thus permitting ready an efficient blood processing.

30 Further, by providing a restricting member in correspondence to the flexible membrane for preventing excessive deformation of the flexible membrane, it is possible to obtain a safer and more durable blood processing apparatus.

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Claims (12)

1. A blood processing apparatus of hollow fiber type characterized by comprising: a hollow fiber bundle having a large number of hollow fibers; a housing accommodating said hollow fiber bundle; a blood port provided on said housing; a blood port zone provided inside said housing and communicating with said blood port; and movable wall means for varying the volume of said blood port zone.

2. The blood processing apparatus of hollow fiber type according to claim 1, characterized in that said hollow fiber bundle has an open end surface constituted by open ends of said hollow fibers, blood flows through said hollow fibers, and said movable wall means is constituted by a movable member facing said end surface of said hollow fiber bundle via said blood port zone and 15 supported by said housing such that it is substantially parallel to said end surface of said hollow fiber bundle and movable in the axial direction thereof toward and away from said end surface.

3. A blood processing apparatus of hollow fiber type according to claim 1 0or 2, characterized in that said hollow fiber bundle has a predetermined diameter, S• 20 said end surface of said hollow fiber bundle is circular, said movable member is :a circular shape corresponding to said circular end surface of said hollow fiber a bundle, said circular movable member has a central increased distance space o a projecting into said blood port zone toward said end surface of said hollow fiber I' bundle, and said blood port extends in the radial direction with respect to the axis F 25 of said hollow fiber bundle. tbspe.058/terumo.div 93 1 8 32

4. The blood processing apparatus of hollow fiber type according to claim 1, 2 or 3, characterized in that said movable wall means is constituted by an elastically deformable flexible membrane provided in said housing.

The blood processing apparatus of hollow fiber type accordiag to any preceding claim characterized by a pressure chamber formed in said housing and applying pressure to said flexible membrane; and operating fluid inlet means provided on said housing for externally introducing operating pressure into said pressure chamber.

6. The blood processing apparatus of hollow fiber type according to any preceding claim, which further comprises: restricting means for restricting the deformation of said flexible membrane.

7. The blood processing apparatus of hollow fiber type according to claim 6, wherein said restricting means has spherical shape and projects toward said end surface of said hollow fiber bundle.

8. The blood processing apparatus according to claim 6 or 7, wherein said restricting means is constituted by an inner wall surface of said housing.

9. The blood processing apparatus according to claim 6 or 7, characterized in that said restricting means is constituted by a net--like member provided in said 0 OV S. 20 housing on the side of said flexible membrane opposite said blood port zone, said net-like member projecting spherically outwardly of said flexible membrane. C

10. The blood processing apparatus of hollow fiber type according to claim 7, characterized in that said housing includes a cylindrical body, said blood port sq-r is provided on the peripheral wall of said cylindrical body, blood introduced into 5 said blood port zone from said blood inlet port flows along the outer side of the tbspe.058/terumo.div 9318 33 hollow fibers of said hollow fiber bundle and is subjected to gas exchange with a medium flowing through said hollow fibers, and said movable wall means is constituted by a flexible membrane stretched on the peripheral wall of said cylindrical body

11. The blood processing apparatus according to claim 10, further comprising restricting means for restricting the deformation of said flexible membrane.

12. The blood processing apparatus of any preceding claim substantially as hereinbefore described with reference to Figures 3 to 13 of the accompanying drawings. DATED 15 February 1994 CARTER SMITH BEADLE Patent Attorneys for the Applicant TERUMO KABUSHIKI KAISHA *e S t. tbspe.058/terumo.div 93 1 8