The present invention relates to a forming method of a bodily fluid purification cassette in which the bodily fluid purification cassette is selectively attached to a bodily fluid purification apparatus body comprising a bubble detector which detects bubbles in a flow passage, a pressure detector which detects a pressure of bodily fluid in the flow passage, a dialysate fluid supply device, a heater, a thermometer, a conductivity meter, a pump rotor of at least one roller type pump, and a control apparatus, the bodily fluid purification cassette incorporates: basic elements comprising at least a bodily fluid flow passage, an air trap and a fluid feed pump tube; a selective element selected from bodily fluid purification elements comprising a dialyzer, a blood filter, a precise filter, a mesh filter, a plasma exchange module and an immunoadsorbent cylinder; and a bodily fluid flow passage which connects the basic element and the selective element with each other, and if the bodily fluid purification cassette which incorporates these elements is attached to the bodily fluid purification apparatus body, the pump rotor of the bodily fluid purification apparatus body cooperates with the fluid feed pump tube of the basic element to constitute a roller type pump, so that desired bodily fluid purification such as blood dialysis, peritoneal dialysis, plasma exchange and immune adsorption can be carried out.
A treating apparatus or a purification apparatus of bodily fluid such as blood is conventionally known as a peritoneal dialysis apparatus, blood dialysis apparatus, a blood dialysis filtering apparatus and the like, and patent document 1 proposes a blood dialysis apparatus for example. Patent document 2 discloses a blood purification apparatus.
Patent document 1: Japanese Patent Application Laid-open No. 2003-305118
Patent document 2: Japanese Patent Application Laid-open No. H9-239024
The blood dialysis apparatus shown in patent document 1 includes a blood dialysis element, i.e., a dialyzer. The dialyzer is provided therein with a dialysis film such as to divide the dialyzer into two in its axial direction, one of them is a blood flow passage and the other one is a dialysate fluid flow passage. Therefore, if blood flows through the blood flow passage and dialysate fluid flows through the dialysate fluid flow passage such that they are opposed to each other, the blood is subjected to dialysis treatment as conventionally known. To subject the blood to the dialysis treatment by the dialyzer, a filter, an air trap, a blood pump, a dialysate fluid supplying and receiving element, an on-off valve, a flowmeter, a control apparatus and the like are also required. Although these elements are not clearly explained in patent document 1, they are accommodated in a casing together with the dialyzer, and a relatively large blood dialysis apparatus is constituted.
The blood purification apparatus proposed in patent document 2 has a blood purification device having a permeable membrane. Blood taken out from a patient is introduced into the blood purification device, and blood from which blood component is filtered is returned to the patient together with displacing solution. At that time, the blood component or filtered liquid is discharged out from a body together with dialysate fluid. To purify blood, a blood pump, a filtered-liquid pump, a replacement liquid pump, a dialysate fluid pump, a control apparatus and the like are also required, they are accommodated in one casing, and the blood purification apparatus is constituted.
In the blood dialysis apparatus proposed in patent document 1, the above-described various elements required for dialysis treatment of blood are accommodated in a casing together with the dialyzer, and a plurality of elements are accommodated in one casing of the blood purification apparatus disclosed in patent document 2 together with the blood purification device and thus, various merits can be obtained. For example, if a plurality of kinds of bodily fluid treating apparatuses such as blood dialysis apparatus and blood purification apparatus are installed in medical facility, a patient can carry out blood permeating treatment and purifying treatment if necessary. Further, a plurality of patients having different diseases can receive treatments at the same time by the respective bodily fluid treating apparatuses. There is also a merit that since the apparatus is a special apparatus, a medical specialist can handle the apparatus easily.
However, there is also a problem or drawback. For example, in order to handle a plurality of patients having different diseases, a plurality of various bodily fluid treating apparatuses must be installed and thus, there is a drawback that the cost is increased. For example, although the number of patients who require dialysis of blood and the number of patients who required purification of blood is not always the same, two kinds of bodily fluid treating apparatuses must be installed. That is, the bodily fluid treating apparatus which has different frequency in use and which is not frequently used must be installed also and thus, the cost is increased. Further, there is a problem in terms of space where a plurality of bodily fluid treating apparatuses are installed. Due to the problem of cost, there is a problem that a small medical facility can not install a bodily fluid treating apparatus for a small number of patients, and the patients must go to a medical facility located far away.
The present invention provides a bodily fluid treating apparatus by which the conventional problems are solved. To solve the problems, a blood dialysis apparatus can be divided into a first portion mainly comprising a dialyzer in terms of effect, and a second portion comprising a bubble detector which detects bubbles in a flow passage through which bodily fluid flows, a pressure gauge which measures a pressure value, a dialysate fluid supply device, a heater, a thermometer, a control apparatus and the like. A blood purification apparatus can also be divided into a first portion mainly comprising a blood purification device, and a second portion comprising a blood pump, a filtered-liquid pump, a liquid-supply pump, a dialysate fluid pump, a control apparatus and the like. It can be found that the second portion of the blood dialysis apparatus and the second portion of the blood purification apparatus have elements which have different names but have the same functions or exhibit the same effects. Hence, the second portions are accommodated in an apparatus body, the first portions are constituted as a bodily fluid purification cassette or a unit, the bodily fluid purification cassette is attached to the apparatus body so that they can carry out different bodily fluid treatments. With this, the conventional problem concerning cost and the problem concerning the installing space can be solved.
Therefore, it is an object of the present invention to inexpensively provide a forming method of a bodily fluid purification cassette which is reduced in size as small as possible and which can be formed as the bodily fluid purification cassette. It is also an object of the invention to provide a forming method capable of automatically form in a sanitary manner. It is also an object of the invention to provide a forming method of a bodily fluid purification cassette suitable for disposable structure.
To achieve the above objects, according to the present invention, basic elements comprising a bodily fluid flow passage, an air trap, and a fluid feed pump tube; and selective elements selected from bodily fluid purification elements comprising a dialyzer, a blood filter, a precise filter, a mesh filter, a plasma exchange module, an immunoadsorbent cylinder; are incorporated in a synthetic resin hollow container. A bodily fluid flow passage which connects the basic element and the selective element and the hollow container are formed as split-type structures by primary molding, and the split-type structures are integrally formed by secondary molding. To achieve the above object, the invention described in claim 1 provides a forming method of a bodily fluid purification cassette in which the bodily fluid purification cassette is selectively attached to a bodily fluid purification apparatus body comprising a bubble detector which detects bubbles in a flow passage, a pressure detector which detects a pressure of bodily fluid in the flow passage, a dialysate fluid supply device, a heater, a thermometer, a conductivity meter, a pump rotor of at least one roller type pump, and a control apparatus, the bodily fluid purification cassette incorporates: basic elements comprising at least a bodily fluid flow passage, an air trap and a plurality of fluid feed pump tubes; a selective element selected from bodily fluid purification elements comprising a dialyzer, a blood filter, a precise filter, a mesh filter, a plasma exchange module and an immunoadsorbent cylinder; and a bodily fluid flow passage which connects the basic element and the selective element with each other, and if the bodily fluid purification cassette which incorporates these elements is attached to the bodily fluid purification apparatus body, the pump rotor of the bodily fluid purification apparatus body cooperates with the fluid feed pump tube of the basic element to constitute a roller type pump, so that desired bodily fluid purification such as blood dialysis, peritoneal dialysis, plasma exchange and immune adsorption can be carried out, wherein a synthetic resin hollow container in which the basic element, the selective element and the bodily fluid flow passage are incorporated, and the bodily fluid flow passage are formed such that a cross section of a split-type structure has a predetermined shape by primary molding, the split-type structure is integrally formed by secondary molding to form the bodily fluid purification cassette in which the basic element, the selective element and the bodily fluid flow passage are incorporated in the synthetic resin hollow container, and when the bodily fluid purification cassette is formed, concerning the bodily fluid flow passage, a pair of first and second semi-molded articles having substantially semi-circular cross section of the split-type structure and a partition member having substantially a plate-like shape are injection molded by primary molding such that the pair of first and second semi-molded articles are provided at their butting portions with coupling flanges, the butting portions of the pair of first and second semi-molded articles sandwich the partition member by secondary molding, molten resin is injected into a junction space constituted by the flange portions of the pair of first and second semi-molded articles, the pair of first and second semi-molded articles and the partition member are liquid-tightly integrally formed together, and the bodily fluid flow passage comprising two flow passages is formed.
The invention described in claim 2 provides a forming method of a bodily fluid purification cassette in which the bodily fluid purification cassette is selectively attached to a bodily fluid purification apparatus body comprising a bubble detector which detects bubbles in a flow passage, a pressure detector which detects a pressure of bodily fluid in the flow passage, a dialysate fluid supply device, a heater, a thermometer, a conductivity meter, a pump rotor of at least one roller type pump, and a control apparatus, the bodily fluid purification cassette incorporates: basic elements comprising at least a bodily fluid flow passage, an air trap and a plurality of fluid feed pump tubes; a selective element selected from bodily fluid purification elements comprising a dialyzer, a blood filter, a precise filter, a mesh filter, a plasma exchange module and an immunoadsorbent cylinder; and a bodily fluid flow passage which connects the basic element and the selective element with each other, and if the bodily fluid purification cassette which incorporates these elements is attached to the bodily fluid purification apparatus body, the pump rotor of the bodily fluid purification apparatus body cooperates with the fluid feed pump tube of the basic element to constitute a roller type pump, so that desired bodily fluid purification such as blood dialysis, peritoneal dialysis, plasma exchange and immune adsorption can be carried out, wherein a synthetic resin hollow container in which the basic element, the selective element and the bodily fluid flow passage are incorporated, and the bodily fluid flow passage are formed such that a cross section of a split-type structure has a predetermined shape by primary molding, the split-type structure is integrally formed by secondary molding to form the bodily fluid purification cassette in which the basic element, the selective element and the bodily fluid flow passage are incorporated in the synthetic resin hollow container, and when the bodily fluid purification cassette is formed, the bodily fluid flow passage is formed by primary molding such that the bodily fluid flow passage includes a pair of first and second semi-molded articles of split-type structure having substantially a semi-circular cross section, butting portions thereof have flange portions and ends of the flange portions have coupling step having increased diameter, connected portions of the basic element and the selective element are inserted into the coupling steps of the first and second semi-molded articles and the molds are clamped, molten resin is injected by secondary molding into a junction space constituted by the flange portions of the first and second semi-molded articles, and into a space between outer peripheries of the connected portions and inner peripheries of the coupling steps of the first and second semi-molded articles, and the basic element and the selective element are liquid-tightly connected to the bodily fluid flow passage.
According to the invention described in claim 3, in the forming method of claim 1 or 2, the primary molding and the secondary molding are carried out using the same mold, and the bodily fluid purification cassette is formed. According to the invention described in claim 4, in the forming method of claim 2, the basic element and the selective element are preheated in the same mold before the secondary molding. According to the invention described in claim 5, in the forming method of any one of claims 1 to 4, when the first and second semi-molded articles are to be formed by the primary molding, they are formed so that a cross section shape of the junction space constituted by the flange portions by butting the butting portions against each other has substantially a triangular shape whose angle portions are rounded, and so that an inner peripheral surface side of the butting portion is recessed radially outward such that its cross section has substantially a triangular shape. According to the invention described in claim 6, in the forming method of any one of claims 1 to 5, the basic element, the selective element and the bodily fluid flow passage are formed such that they can be accommodated in a synthetic resin hollow container having a size equal to or less than 220 mm in vertical length, 300 mm in lateral length and 80 mm in height.
According to the present invention, the bodily fluid purification cassette has a synthetic resin hollow container, the container includes basic elements comprising at least a bodily fluid flow passage, an air trap and a fluid feed pump tube; a selective element selected from bodily fluid purification elements comprising a dialyzer, a blood filter, a precise filter, a mesh filter, a plasma exchange module and an immunoadsorbent cylinder; and a bodily fluid flow passage which connects the basic element and the selective element with each other, the bodily fluid flow passage are formed such that a cross section of a split-type structure has a predetermined shape by primary molding, the split-type structure is integrally formed by secondary molding to form the bodily fluid purification cassette in which the basic element, the selective element and the bodily fluid flow passage are incorporated in the synthetic resin hollow container. When the bodily fluid purification cassette is formed, concerning the bodily fluid flow passage, a pair of first and second semi-molded articles having substantially semi-circular cross section of the split-type structure and a partition member having substantially a plate-like shape are injection molded by primary molding such that the pair of first and second semi-molded articles are provided at their butting portions with coupling flanges, the butting portions of the pair of first and second semi-molded articles sandwich the partition member by secondary molding, molten resin is injected into a junction space constituted by the flange portions of the pair of first and second semi-molded articles, the pair of first and second semi-molded articles and the partition member are liquid-tightly integrally formed together, and the bodily fluid flow passage comprising two f low passages is formed. That is, since the bodily fluid purification cassette is formed by the injection molding, it can be automatized easily, and it can be formed inexpensively. Further, since it is formed by the mold, it can be formed in a sanitary manner. As described above, according to the present invention, it is possible to obtain effect which is unique to the invention that the bodily fluid purification cassette can inexpensively and automatically be formed or produced in a sanitary manner. The bodily fluid flow passage obtained by this forming method can be utilized as reciprocating roads or two-way roads, and there is an effect that the bodily fluid purification cassette can further be reduced in size.
According to another invention, the bodily fluid flow passage of the bodily fluid purification cassette is formed by primary molding such that the bodily fluid flow passage includes a pair of first and second semi-molded articles of split-type structure having substantially a semi-circular cross section, butting portions thereof have flange portions and ends of the flange portions have coupling step having increased diameter, connected portions of the basic element and the selective element are inserted into the coupling steps of the first and second semi-molded articles and the molds are clamped, molten resin is injected by secondary molding into a junction space constituted by the flange portions of the first and second semi-molded articles, and into a space between outer peripheries of the connected portions of the basic element and the selective element and inner peripheries of the coupling steps of the first and second semi-molded articles, and the basic element and the selective element are liquid-tightly connected to the bodily fluid flow passage. Therefore, in addition to the above effect, there is a further effect that the basic element and the selective element are liquid-tightly integrally formed with the bodily fluid flow passage when the bodily fluid flow passage is formed. Further, according to the invention for preheating the basic element and the selective element in the same mold before the secondary molding, heat which must cool the mold for taking out the molded article is effectively utilized to preheat, and the basic element and the selective element can be connected to the bodily fluid flow passage while saving energy. Further, when the first and second semi-molded articles are to be formed by the primary molding, they are formed so that a cross section shape of the junction space constituted by the flange portions by butting the butting portions against each other has substantially a triangular shape whose angle portions are rounded, and so that an inner peripheral surface side of the butting portion is recessed radially outward such that its cross section has substantially a triangular shape. According to this invention, the junction space is expanded or deformed by the pressure of resin which is charged into the junction space at the time of secondary molding, and the inner peripheral surface sides of the butting portions are brought into contact with each other under pressure. With this, a bodily fluid flow passage having extremely small gap between the butting portions, or having no gap therebetween can be obtained.
Embodiments of the present invention will be explained. According to the embodiment, as shown in
As conventionally known, the roller type pump includes a substantially arc pump tube, and a pump rotor which is rotated and driven in the pump tube. Driving sections of the pump rotors are provided in the bodily fluid purification apparatus body T, but the pump rotors PR1 to PR4 project outward from a bottom wall of the mounting recess SB. Since the pump rotors PR1 to PR4 project, if the bodily fluid purification cassettes U1, U2, . . . are mounted, as will be described in detail later, the pump rotors PR1 to PR4 are accommodated in roller type pump elements PY1 to PY4 of the bodily fluid purification cassettes U1, U2, . . . . Therefore, if the pump rotors PR1 to PR4 of the bodily fluid purification apparatus body B are rotated and driven, the pump tubes PT1 to PT4 provided on the side of the bodily fluid purification cassettes U1, U2, . . . are sequentially crushed between a stator and the pump rotors PR1 to PR4, and bodily fluid or dialysate fluid in the pump tubes PT1 to PT4 is sent under pressure.
Other embodiments of the bodily fluid purification cassettes U1, U2, . . . are shown
This will be explained in more detail. In the embodiment shown in
Since the blood dialysis cassette U1 of the embodiment has the above-described structure, the blood dialysis cassette U1 is mounted on the bodily fluid purification apparatus body T, catheters connected to an artery and a vein of a patient are connected to connectors 6 and 7, and an operation switch SW1 for blood dialysis of the bodily fluid purification apparatus body T is pushed. Then, the selected pump rotors PR3 and PR4 are rotated, and the third and fourth roller type pumps P3 and P4 are operated. Blood is sucked from the bodily fluid flow passage R1 by the third roller type pump P3, and is discharged into the bodily fluid flow passage R2. Then, the blood passes through the air trap 1, passes through the branch point J1 from the bodily fluid flow passage R3 and is sent from the bodily fluid flow passage R4 into the dialyzer 2 under pressure, and flows downward in the dialyzer 2. Dialysate fluid is supplied from the upper supply hole 8 of the precise filter 3. The dialysate fluid flows through the dialyzer 2 from below to upward, and is discharged out from the blood dialysis cassette U1 from the upper discharge opening 9 of the dialyzer 2. The dialyzer 2 is provided with the dialysis film as in the conventional technique as described above. Therefore, while blood and dialysate fluid flow in the opposed manner, the blood is dialyzed. Then, it is sent to the mesh filter 4 under pressure through the bodily fluid flow passage R5, the branch point J3 and the bodily fluid flow passage R6. Fibrin cluster generated in the blood is removed by the mesh filter 4, pressure thereof is increased by the fourth roller type pump P4, and the blood is returned toward the vein of the patient from the bodily fluid flow passage R7 through the connector 7. When the pump rotor PR4 of the fourth roller type pump P4 opens the fluid feed pump tube PT4 during the dialysis, the fourth roller type pump P4 can be remain stopping.
According to the blood dialysis cassette U1 of the embodiment, the dialysis treatment of blood can be carried out. The blood dialysis filtering treatment, the blood filtering treatment and the priming operation for using the blood dialysis cassette can also be carried out by appropriately operating or stopping the first to fourth roller type pumps P1 to P4. These treatments are apparent for a person skilled in the art, explanation thereof will be omitted.
The present invention is to form a bodily fluid purification cassette such as the blood dialysis cassette U1 and the peritoneal dialysis cassette U2 by means of primary and secondary injection molding. That is, the invention provides a forming method for forming by means of injection molding while using, as a split-type structure, a synthetic resin hollow container in which a bodily fluid purification element is incorporated and a bodily fluid flow passage which connects the bodily fluid purification element, or provides a forming method for integrally connecting the bodily fluid purification element to the bodily fluid flow passage when the bodily fluid flow passage is to be molded.
First, an embodiment of the forming method of the bodily fluid flow passage R will be explained. Constituent elements of the bodily fluid purification cassettes U1, U2, . . . are accommodated in upper and lower box-like bodies F1 and F2 as shown in
An embodiment of the forming mold of the bodily fluid flow passage R is shown in
Next, a forming example for forming the bodily fluid flow passage R4 shown in
Molten resin is injected from the injection unit into the cavities C1 to C3 through the sprue 47, the runner 48, the sprues 47′, 47′ and 47′ and gates (not shown in
The partition member 25 is taken out by a robot for example and is inserted into the second semi-molded article 20′. That is, an end of the partition member 25 is placed on the coupling step 22 of the second semi-molded article 20′. The slide mold 52 is driven to the secondary molding position shown in
In this embodiment, since the partition member 25 is provided, two first and second flow passages 28 and 29 are formed by the partition member 25, but it is of course possible to eliminate the partition member 25 so that the bodily fluid flow passage comprising one flow passage can be formed by the first and second semi-molded articles 20a and 20′a.
Next, a molding example in which separately obtained insert articles, i.e., bodily fluid purification elements such as the air trap 1, the precise filter 3 and the fluid feed pump tubes PT1 to PT4 which are constituent elements of the roller type pump when the bodily fluid flow passage R is molded are integrally connected to the bodily fluid flow passage R will be explained.
The moving mold 70 pair off with the fixed mold 60. A core 73 having substantially a semi-circular cross section is provided on the side of the parting line P. The core 73 is for forming the second semi-molded article 20′c. A recess 71 having substantially a circular cross section is provided on the right side of the core 73. The recess 71 forms the first semi-molded article 20c. As shown in
A molding example of a molded article as shown in
Although it is not illustrated in the drawing, molten resin for primary molding is injected from the fixed mold 60 toward the cavities C′1 and C′2 from the injection unit. By this primary molding, as shown in
The present invention can be carried out in various forms. For example, although the moving mold 70 rotates in the above embodiment, the moving mold 70 can also slide as explained with reference to
In the above explanation, the mold used for molding the bodily fluid flow passage of the bodily fluid purification cassette such as the blood dialysis cassette and the peritoneal dialysis cassette, and a mold which integrally forms the insert article when the bodily fluid flow passage is to be molded are different from each other, but it is apparent that they can be molded using one mold. It is also apparent that a relatively large recess is separately formed in the parting line of such a mold, an insert article is put into the recess at the time of primary molding, and it can be preheated.
As shown in
It is possible to inexpensively produce, in a sanitary manner, a bodily fluid purification cassette which is reduced in size as small as possible, which is mounted on and cooperates with a bodily fluid treating apparatus body to carry out bodily fluid purification, in which a bodily fluid purification element suitable for use such as blood dialysis or peritoneal dialysis, and a bodily fluid flow passage which is liquid-tightly connected to the bodily fluid purification element are provided.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/JP2007/000189 | 3/9/2007 | WO | 00 | 10/29/2009 |