Source: http://www.google.fr/patents/US4643715
Timestamp: 2013-06-19 22:20:11
Document Index: 645814391

Matched Legal Cases: ['art 6200', 'art 5700', 'art 8100', 'art 6700', 'art 8900', 'art 8100']

Brevet US4643715 - Artificial organ and method for manufacture thereof - Google�BrevetsRecherche Images Maps Play YouTube Actualit�s Gmail Drive Plus » Recherche avanc�e dans les brevets | Historique Web | Connexion Recherche avanc�e dans les brevets BrevetsMedical permeating membranes in a zone through which a body fluid flows, said membranes having lateral surfaces in said zone, comprising permeable membranes of regenerated cellulose and a film of a fat-soluble vitamin and glycerin on said lateral surfaces of said membranes in said zone for flow of body...http://www.google.fr/patents/US4643715?utm_source=gb-gplus-shareBrevet US4643715 - Artificial organ and method for manufacture thereof Num�ro de publicationUS4643715 AType de publicationOctroi Num�ro de demande06/878,059 Date de publication17 f�vr. 1987 Date de d�p�t24 juin 1986 Date de priorit�9 sept. 1982Autre r�f�rence de publicationDE3378461D1, EP0103816A2, EP0103816A3, EP0103816B1, US4588407, US4634447 Num�ro de publication06878059, 878059, US 4643715 A, US 4643715A, US-A-4643715, US4643715 A, US4643715A InventeursKeinosuke Isono, Keiji Naoi Cessionnaire d'origineTerumo Kabushiki KaishaCitations de brevets (2), R�f�renc� par (28), Classifications (19) Liens externes: USPTO, Cession USPTO, EspacenetArtificial organ and method for manufacture thereofUS 4643715 A R�sum� Medical permeating membranes in a zone through which a body fluid flows, said membranes having lateral surfaces in said zone, comprising permeable membranes of regenerated cellulose and a film of a fat-soluble vitamin and glycerin on said lateral surfaces of said membranes in said zone for flow of body fluid.
2. The medical permeating membranes according to claim 1, wherein said film contains said fat-soluble vitamin in an amount of not less than 0.1 mg per m.sup.2 of said permeable membranes of regenerated cellulose and glycerin in an amount of at least 0.5% based on the weight of said permeable membranes of regenerated cellulose.
This invention is directed to a method for the manufacture of an artificial organ wherein the organic solvent is at least one member selected from the group consisting of a chlorofluorohydrocarbon, a fluorohydrocarbon and a lower alcohol. This invention is directed to a method for the manufacture of an artificial organ wherein the concentration of the fat-soluble vitamin in the solution thereof in the organic solvent is in the range of from 0.01 to 10 w/v%. This invention is further directed to a method for the manufacture of an artificial organ wherein the drying of the deposited solution is effected by passing through the aforementioned body fluid-flowing zone a gas inert to the aforementioned fat-soluble vitamin at a temperature in the range of from 10 invention is also directed to a method for the manufacture of a sterilized artificial organ wherein the aforementioned physiologically harmless liquid comprises water, physiological saline solution, or an aqueous glycerin solution.
Examples of vitamin A include vitamins A such as retinol, vitamin A.sub.1 alcohol, retinal, vitamin A.sub.1 aldehyde, vitamin A.sub.1 acid, 3-dehydroretinal, vitamin A.sub.2 alcohol, 3-dehydroretinal and vitamin A.sub.2 aldehyde; provitamins A such as β-carotene, α,α-carotene, α-carotene, β,ε-carotene, γ-carotene and β,φ-carotene; and cisvitamins A.
Examples of vitamin D include vitamins D such as vitamin D.sub.2, vitamin D.sub.3, vitamin D.sub.4, vitamin D.sub.5, vitamin D.sub.6 and vitamin D.sub.7 ; and corresponding provitamins D.
Examples of vitamin K include vitanins K.sub.1 and vitamins K.sub.2. Examples of ubiquinone include ubiquinone-1 through ubiquinone-12 (Q-1 through Q-12), and oxides and axino-related compounds thereof.
The fat-soluble vitamin is dissolved at a concentration in the range of from 0.01 to 10 w/v %, preferably from 0.05 to 2.0 w/v %, in an organic solvent. The solution thus prepared is caused to flow into the body fluid-flowing zone of the artificial organ (the blood-flowing zone in the case of the artificial kidney illustrated in FIG. 1 and FIG. 2) and allowed to remain in contact with the zone for a stated period such as, for example, 30 seconds to 60 minutes, preferably 1 to 10 minutes so as to have the inner surfaces of the parts in the aforementioned zone such as, for example, the inner surfaces of the tube 14, the cavity defined by the header 10 and the potting ring 6, the hollow fiber, the cavity defined by the header 11 and the potting ring 7, and the tube 15 amply wetted with the aforementioned fat-soluble vitamin. A film of the aforementioned fat-soluble vitamin is deposited on the aforementioned surfaces by subsequently discharging the solution from the artificial organ and introducing into the artificial organ a gas inert to the fat-soluble vitamin such as, for example, air, nitrogen or carbon dioxide gas at a temperature in the range of from 10 from 15 distillation from the solution. When necessary, the artificial organ may be rinsed with water. In this case, the film of the fat-soluble vitamin may be formed particularly in the portion packed with the permeating membranes. Especially in the artificial organ incorporating regenerated cellulose membranes which are liable to induce hemodialysis leukopenia, a notable effect in curbing this detestable phenomenon can be obtained by having the film of fat-soluble vitamin deposited preponderantly on the portion packed with the permeating membranes. Where such permeating membranes are made of regenerated cellulose, particularly regenerated cellulose of the cuprammonium process, the aforementioned solution of fat-soluble vitamin in the organic solvent may additionally incorporate glycerin therein. The addition of glycerin serves the purpose of enhancing the hydrophilicity of the permeating membrane. It is, therefore, effective in artificial organs such as artificial kidney and artificial liver which are required to use hydrophilic permeating membranes. The concentration of glycerin in the aforementioned solution is in the range of from 0.1 to 10 w/v %, preferably from 1 to 5 w/v %.
EXAMPLE 1 A bundle of 368 hollow fibers of regenerated cellulose product of the cuprammonium process each measuring 200 μm in inside diameter, 220 μm in outside diameter, and 14 to 14.5 cm in length was inserted in a tubular main barrel 4, with the opposite ends of the bundle fixed in position with potting rings 6, 7 both of polyurethane as illustrated in FIG. 1. Headers 10, 11 were attached to the opposite ends of the tubular main barrel 4 and caps 12, 13 were helically set to immobilize the headers 10, 11 to the tubular main barrel 4 and complete a dialyzer (artificial kidney) 1. The total inner surface of the membranes in this dialyzer was found to be 300 cm.sup.2.
Separately, an ethanol solution of vitamin E (DL-α-tocopherol) and glycerin was prepared by dissolving 1.0 g of vitamin E and 2.0 g of glycerin in 100 ml of ethanol. A 50-ml syringe was connected to one end of the aforementioned dialyzer 1, with the other end of the dialyzer 1 immersed in the aforementioned solution of vitamin E. By operating the plunger of this syringe, the dialyzer 1 was filled with the vitamin E solution. The dialyzer 1 was then allowed to stand in situ at room temperature for about 5 minutes. Then, the dialyzer 1 was lifted out of the solution and caused to discharge an excess of the vitamin E solution. It was subsequently connected to an aspirator and was dried in a stream of air at a temperature of 25 dialyzer was left standing overnight in an oven kept at 60 dialyzer thus completed was autoclaved at 115 for the purpose of sterilization. Inside the dialyzer thus obtained, the film of vitamin E formed therein was estimated to have a theoretical thickness of about 0.05 μm.
The blood platelet expansion test was conducted by the following procedure. In a syringe made of polypropylene and containing 0.5 ml of 3.8% sodium citrate, 4.5 ml of intravenous blood was taken from a healthy human being. The blood now containing sodium citrate was transferred into a test tube made of polypropylene and centrifuged at 800 r.p.m. for five minutes. The resultant PRP was combined with a diluent (a 9:1 mixture of physiological saline solution and 3.8% sodium citrate) to prepare a suspension of blood platelets. This suspension was dropped on a given test piece (a plate 0.4 mm in thickness). The test piece wetted with the suspension was left standing for a stated length of time to permit deposition and expansion of blood platelets. The blood platelets were fixed with 2% glutaraldehyde, gradually dehydrated with ethanol solutions of serially changed concentrations, then dried, and observed under an electron microscope. The results of the blood platelet expansion test were rated by the count of blood platelets deposited in a unit area of 0.11 mm.sup.2 and the morphological alteration of blood platelets. The morphological alteration was classified into the following three types:
On a rabbit 20 prepared as described above, a varying dialyzer 1 obtained in Examples 1-2 and Control 1 was incorporated to establish an experiment circuit. A catheter 21 connected to the artery of the rabbit 20 was connected to a pump 22. A bypass catheter 23 was connected to the aforementioned catheter 21. This bypass catheter 23 was connected to a chamber 24 which communicated with an outlet 25 side of a manometer. The chamber 24 and the artery of the rabgit 20 were joined with a catheter 26. The pump 22 and the dialyzer 1 were joined with a tube 27, which communicated with an inlet 28 side of the manometer. Further, the dialyzer 1 and the chamber 24 were joined with a tube 29. In the meantime, the outlet and the inlet of the dialyzer 1 for passage of the dialyzing liquid were joined with a tube 30. This tube 30 incorporated therein a pump 31 and was immersed in a water bath 32 kept at 37 formed was subjected to priming purge with the physiological saline solution containing 1 IU of heparin per ml (100 ml).
The blood taken from the rabbit was diluted to twice the original volume with phsiological saline solution containing 1.5% EDTA-3K and calculated with an ELT-8 (Ortho Instrument). The counts of leukocytes (WBC), the counts of blood platelets (PLT), and the hematocrit numbers (HCT) consequently determined were as shown in Tables 3-5. The counts of leukocytes and the counts of blood platelets were compensated for the relevant hematocrit numbers in accordance with the following formula and were reported as the values corresponding to the HCT values existing immediately before start of circulation of the blood through the circuit. ##EQU1## wherein C.sub.x stands for value of compensation, C.sub.o for found value, HCT.sub.x for compensated standard Hct value=initial Hct value, and HCT.sub.o for Hct value existing when the value of C.sub.o was obtained.
TABLE 3______________________________________(Vitamin E 1.0%)WBC            PLT            HCT         PIC              PIC         PICTime  /mm.sup.3         (%)                                (%)    %    (%)______________________________________Start 6200    100.0    61.3    100.0  43.3 100.0 5 min. 5710    92.1     57.3    93.5   39.4 91.010    5530    89.2     56.3    91.8   39.9 92.115    5520    89.0     54.8    89.4   39.2 90.520    5200    83.9     53.4    97.1   39.1 90.330    5240    84.5     50.6    82.5   39.7 91.745    5150    83.1     46.7    76.1   39.5 91.2 1 hr. 6030    97.3     46.1    75.2   38.8 89.6 2    7380    119.0    42.4    69.2   39.3 90.7 3    6650    107.3    34.9    56.9   41.0 94.7 4    6710    108.2    37.1    60.5   41.3 95.4 5    7640    123.2    37.9    61.8   40.8 94.2 6    7490    120.8    36.8    60.0   39.9 92.1______________________________________ PIC means percent of initial count.
TABLE 4______________________________________(Vitamin E. 0.1%)WBC            PLT            HCT         PIC              PIC         PICTime  /mm.sup.3         (%)                                (%)    %    (%)______________________________________Start 5700    100.0    61.6    100.0  45.4 100.0 5 min. 5340    93.7     53.2    86.4   40.8 89.910    5410    94.9     54.4    88.3   40.3 88.815    5030    88.2     53.9    87.5   40.6 89.420    4780    78.6     47.1    76.5   40.6 89.430    4630    81.2     42.4    68.8   42.2 93.045    5080    89.1     38.8    63.0   40.2 88.5 1 hr. 5040    88.4     37.9    61.5   40.5 89.2 2    6320    110.9    32.2    52.3   39.5 87.0 3    7640    134.0    33.8    54.9   39.8 87.7 4    9750    171.1    34.3    55.7   39.1 86.1 5    10590   185.5    32.8    52.4   40.3 88.8 6    11870   208.2    29.9    48.5   39.0 85.9______________________________________
TABLE 5______________________________________(Vitamin E none)WBC            PLT            HCT         PIC              PIC         PICTime  /mm.sup.3         (%)                                (%)    %    (%)______________________________________Start 8100    100.0    86.4    100.0  44.4 100.0 5 min. 4230     52.2    79.8    92.4   39.9 89.910    3850     47.5    76.8    88.9   39.2 88.315    4100     50.6    73.2    84.7   41.2 92.820    4520     55.8    71.4    82.6   40.3 90.830    6820     84.2    69.8    80.8   38.4 86.545    6870     84.8    66.7    77.2   39.4 88.7 1 hr. 8790    108.5    64.8    75.0   38.9 87.6 2    11520   142.2    54.7    63.3   39.7 89.4 3    13720   169.4    47.8    55.3   38.2 86.5 4    18130   223.8    50.3    58.2   38.7 87.2 5    22500   277.8    52.3    60.5   37.1 83.6 6    22690   280.1    55.7    64.5   36.6 82.4______________________________________
EXAMPLE 5 A dialyzer was produced by following the procedure of Example 1, except that the dialyzer which had been left standing overnight in an over at 60 autoclave, and heated therein at a temperature of 115 minutes for the purpose of sterilization.
TABLE 6______________________________________(Vitamin E 1.0%)WBC            PLT            HCT         PIC              PIC         PICTime  /mm.sup.3         (%)                                (%)    %    (%)______________________________________Start 6700    100.0    71.0    100.0  48.0 100.0 5 min. 5830     87.0    68.0    95.8   42.8 89.210    5050     75.4    66.0    93.6   41.8 87.115    4940     73.7    68.5    96.5   44.7 93.120    4950     73.9    63.5    89.4   44.6 92.930    5930     88.5    59.5    83.8   41.3 86.045    6590     98.4    55.1    77.6   43.7 91.0 1 hr. 7650    114.2    58.2    82.0   43.9 91.5 2    9380    140.0    51.8    73.0   43.0 89.6 3    10400   155.2    43.8    61.7   43.4 90.4 4    9950    148.5    36.8    51.8   44.4 92.5 5    10740   160.3    38.5    54.2   43.8 91.3 6    11690   174.5    39.3    55.4   42.7 89.0______________________________________ PIC means percent of initial count.
TABLE 7______________________________________(Vitamin E 0.1%)WBC            PLT            HCT         PIC              PIC         PICTime  /mm.sup.3         (%)                                (%)    %    (%)______________________________________Start 8900    100.0    85.7    100.0  51.7 100.0 5 min. 8210    92.2     93.0    108.5  42.8 82.710    6700    75.2     85.3    99.5   46.3 89.615    6110    68.7     79.7    93.0   47.4 91.720    6080    68.3     74.8    87.3   46.8 90.530    6780    76.2     63.3    73.9   47.3 91.545    7660    85.4     57.8    67.4   48.3 93.4 1 hr. 8180    91.9     53.9    62.9   47.4 91.6 2    7850    88.2     46.5    54.3   48.1 93.0 3    10890   122.4    38.9    45.4   45.3 87.2 4    13120   147.4    32.5    37.9   45.3 87.6 5    13720   154.2    36.6    42.7   45.6 88.2 6    13700   153.9    39.2    45.7   43.4 83.9______________________________________
TABLE 8______________________________________(Vitamin E none)WBC            PLT            HCT         PIC              PIC         PICTime  /mm.sup.3         (%)                                (%)    %    (%)______________________________________Start 8100    100.0    86.4    100.0  44.4 100.0 5 min. 4230     52.2    79.8    92.4   39.9 89.910    3850     47.5    76.8    88.9   39.2 88.315    4100     50.6    73.2    84.7   41.2 92.820    4520     55.8    71.4    82.6   40.3 90.830    6820     84.2    69.8    80.8   38.4 86.545    6870     84.8    66.7    77.2   39.4 88.7 1 hr. 8790    108.5    64.8    75.0   38.9 87.6 2    11520   142.2    54.7    63.3   39.7 89.4 3    13720   169.4    47.8    55.3   38.2 86.5 4    18130   223.8    50.3    58.2   38.7 87.2 5    22500   277.8    52.3    60.5   37.1 83.6 6    22690   280.1    55.7    64.5   36.6 82.4______________________________________
TABLE 9______________________________________(Vitamin E 0.5%)WBC            PLT            HCT         PIC              PIC         PICTime  /mm.sup.3         (%)                                (%)    %    (%)______________________________________ 0    7870    100.0    84.4    100.0  46.7 100.0 5    8030    102.0    84.8    100.5  41.0 87.810    7290     92.6    85.0    100.7  44.7 95.715    6550     83.2    81.2    96.2   42.4 90.820    6300     80.1    77.0    91.2   42.3 90.630    7290     92.6    72.0    85.3   42.7 91.445    8000    101.1    67.1    79.5   41.1 88.060    8930    113.5    62.8    74.4   41.4 88.7120   11800   149.9    62.1    73.6   39.5 84.6______________________________________
TABLE 10______________________________________(Vitamin E none)WBC            PLT            HCTTime          PIC              PIC         PIC(min) /mm.sup.3         (%)                                (%)    %    (%)______________________________________ 0    8880    100.0    66.7    100.0  47.0 100.0 5    7160    80.6     65.1    97.6   39.5 84.010    5900    66.4     63.5    95.2   40.6 86.415    4480    50.5     60.7    91.0   40.8 86.820    5030    56.6     58.5    87.7   40.5 86.230    6530    73.5     52.9    79.3   40.4 86.0 45.  7790    87.7     53.1    79.6   40.4 86.060    8340    93.9     49.7    74.5   40.0 85.1120   9610    108.2    45.4    68.1   38.6 82.1______________________________________
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