Patent Application
20080262385
The present invention relates to a backflow preventing structure of a blood sampler used for sampling blood, and more specifically, to a backflow preventing structure, and a luer adapter, a blood sampling needle and a blood sampling holder having a backflow preventing structure.
In current blood sampling methods such as vacuum blood sampling, a variety of blood sampling needles and blood sampling holders are used. In sampling of blood, first a tourniquet is attached to an arm of a subject whose blood is to be sampled. Then a needlepoint of a blood sampling hollow needle is inserted into a blood vessel. The blood sampling hollow needle is connected with a communicating hollow needle for piercing a plug member of a vacuum blood sampling tube. Various structures such as a hub having an internal channel have been proposed as the structure that connects the blood sampling hollow needle and the communicating hollow needle.
In conducting vacuum blood sampling, after inserting the needlepoint of the blood sampling hollow needle into the blood vessel as described above, the plug member of the vacuum blood sampling tube is pierced by the needlepoint of the communicating hollow needle. This makes the blood sampling hollow needle and the interior of the vacuum blood sampling tube in communication with each other. Since the interior of the vacuum blood sampling tube is depressurized, blood is introduced from the blood vessel to the vacuum blood sampling tube.
Blood sampling completes when the internal pressure of the vacuum blood sampling tube and the pressure of the blood vessel come are almost nearly equivalent with each other. After completion of blood sampling, the communicating hollow needle is withdrawn from the vacuum blood sampling tube, and the tourniquet is removed. However, if the tourniquet is erroneously removed in first, the blood in the blood sampling tube may possibly backflow toward the blood vessel due to a sudden drop in internal pressure of the blood vessel. When the blood sampling tube is placed at a higher position than the blood vessel, the potential energy may cause backflow. On the other hand, a vacuum blood sampling tube often contains an anticoagulant, a medical agent and the like. Therefore, if backflow occurs, such an anticoagulant and a medical agent move toward the blood vessel to exert an adverse effect. In view of the above, various structures for preventing backflow have been proposed heretofore.
For example, Patent document 1 recited blow discloses a blood sampling needle 101 shown in
Therefore, when blood flows within the internal channel 104a from the first hollow needle 102 toward the second hollow needle 103, a gap of the check valve 105 opens to allow the blood pass through. To the contrary, when blood is about to flow in the counter direction, the gap in tip end is closed by the pressure of blood, whereby backflow of the blood is prevented.
In the meanwhile, Patent document 2 recited below discloses a blood sampling needle 111 equipped with a backflow preventing structure shown in
FIG. 4 of Patent document 3 recited blow discloses a backflow preventing structure in a blood sampling part utilizing a valve made of an elastic material. Here, the valve made of an elastic material is formed with a slit extending in the flow path direction of the blood sampling part, namely in the axial direction of the tubular body. This ensures that the slit is closed by backflow if such backflow occurs.
Patent document 1: Japanese Patent Application Laid-open Publication No. 03-129111
Patent document 2: Japanese Patent Application Laid-open publication No. 2003-260132
Patent document 3: Japanese Patent Application Laid-open publication No. 50-12892
In the blood sampling needle 101 disclosed in the Patent document 1, backflow was prevented by providing the backflow preventing valve 105 in the internal channel 104a. However, when the backflow preventing valve 105 has a conical shape, an outlet for blood is very narrow, so that hemolysis is likely to occur during passage of blood although backflow is prevented. Additionally, when such check valve 105 is made by molding, another problem arises that miniaturization is difficult to be achieved.
In the blood sampling needle 111 disclosed in Patent document 2, the backflow preventing member 114 having the cross cut 114a formed by cutting the tip end in a cross shape is used. In this case, it is necessary to accurately cut an elastic member from bottom end side into a crossing cut. This increases the processing steps, and hence such measure is not appropriate for production of blood sampling needles that are consumed in the order of 0.5 to 10 billions every year. Additionally, since a blood sampling needle is a disposable component, the cost of blood sampling needle necessarily rises when such a needle that has a crossing cut as is the case of the backflow preventing member 114 is used. Additionally, as shown in
In the structure disclosed in Patent document 3 in which a valve of elastic material having a slit is used, when the pressure of backflow is high, the valve parts on each end of the slit is pushed inside by backflow to open the slit, which leads failure in secure prevention of backflow.
It is an object of the present invention to provide a backflow preventing structure of a blood sampler which solves the problems of conventional arts, and securely prevents backflow during blood sampling, while eliminating a risk of hemolysis and enabling provision at low cost without causing increase in process steps.
It is another object of the present invention to provide as a blood sampler equipped with the above backflow preventing structure of a blood sampler, a luer adapter, a blood sampling needle and a blood sampling holder.
A blood sampler according to the present invention is a backflow preventing structure for preventing backflow of blood in a blood sampler, and includes a tubular body having an internal channel extending from a first end part toward a second end part through which blood flows, and a backflow preventing member contained in the internal channel of the tubular body, made of a material having rubber elasticity. The backflow preventing member is a bottomed tube closed on the second end part side and having an opening that opens toward the first end part. The blood sampler is characterized in that an outer circumferential wall of the backflow preventing member is secured liquid-tightly to an inner wall of the internal channel, and a cut is made in the backflow preventing member at a part closer to the second end part side than the secured part.
In one specific aspect of the backflow preventing structure of a blood sampler according to the present invention, the cut is provided in at least two positions in the backflow preventing member.
In another specific aspect of the backflow preventing structure of a blood sampler according to the present invention, the cut formed in the backflow preventing member extends in a direction that intersects with a direction connecting the first end part and the second end part.
In other specific aspect of the backflow preventing structure of a blood sampler according to the present invention, the cut formed in the backflow preventing member extends in a direction inclined at an angle ranging from 15 to 165 degrees with respect to the direction connecting the first end part and the second end part, i.e., with respect to the extending direction of the internal channel.
In a further specific aspect of the backflow preventing structure of a blood sampler according to the present invention, the cut formed in the backflow preventing member extends in a direction perpendicular to the direction connecting the first end part and the second end part.
In other specific aspect of the backflow preventing structure of a blood sampler according to the present invention, a part that serves as a hinge for opening/closing achieved by the cut has a relatively smaller thickness than the remaining part.
A luer adapter according to the present invention includes a hollow needle used for piercing a plug member of a blood sampling tube in blood sampling, and a hub secured to one end of the hollow needle, wherein the hub has the backflow preventing structure of a blood sampler configured according to the present invention, and the hollow needle is in communication with the second end part side of the internal channel of the backflow preventing structure of a blood sampler.
A blood sampling needle according to the present invention includes a hollow needle for collecting blood; and a hub secured to one end of the hollow needle, wherein the hub has the backflow preventing structure of a blood sampler configured according to the present invention, and the hollow needle is in communication with the first end part side of the internal channel of the backflow preventing structure of a blood sampler.
A blood sampling holder of the present invention includes a tubular holder main body formed with an opening for inserting a blood sampling tube at its one end, and closed at the other end; a hub provided on the other end side of the holder main body; and a hollow needle secured at its one end to the hub, for piercing a plug member of the blood sampling tube, wherein the hub has the backflow preventing structure of a blood sampler configured according to the present invention, and the hollow needle is in communication with the second end part side of the internal channel of the backflow preventing structure of a blood sampler.
In one specific aspect of the blood sampling holder according to the present invention, a blood sampling hollow needle having one end secured to the hub and the other end extended outside the holder is further included, wherein the blood sampling hollow needle is in communication with the first end part side of the internal channel of the backflow preventing structure of a blood sampler.
In the backflow preventing structure of a blood sampler of the present invention, the backflow preventing member is contained in the internal channel of the tubular body having the internal channel extending from the first end part toward the second end part through which blood flows, and the backflow preventing member is made of a material having rubber elasticity, and has a shape of a bottomed tube closed on the second end part side and having an opening that opens toward the first end part; and the outer circumferential wall of the backflow preventing member is secured liquid-tightly to the inner wall of the internal channel; and the cut is made in the backflow preventing member at a part closer to the second end part side than the secured part.
Accordingly, when blood flows from the first end part toward second end part in the internal channel, the cut provided in the backflow preventing member made of a material having rubber elasticity is opened by being pushed by the blood, to allow passage of the blood. In this case, since the backflow preventing member is made of a flexible material having rubber elasticity, the cut is readily opened, so that hemolysis is unlikely to occur.
On the other hand, when the blood is about to backflow from the second end part toward the first end part, the cut is closed by force of blood flow. Also in this case, since the backflow preventing member is made of a flexible material having rubber elasticity, the cut is securely closed by force of blood flow, so that backflow is securely prevented.
Since all that is necessary is to form a cut in the backflow preventing member which is a bottomed tube made of a material having rubber elasticity, and to secure it in the internal channel, it is possible to provide an inexpensive backflow preventing structure without causing a significant increase in number of process steps and components.
In the backflow preventing member, when cuts are provided in at least two positions, the backflow preventing member is secured aslant in the internal channel of the tubular body, and at least one of the cuts comes into close contact with the inner wall of the tubular body. Accordingly, even if one of the cuts fails to open, the remaining at least one cut will securely open to enable blood sampling.
When the cut is formed in the backflow preventing member in the direction that intersects with the direction connecting the first and the second end parts, the cut part is closed more securely by force of blood flow in the case of backflow. Additionally, only by forming a cut in the direction that intersects with the direction connecting the first and the second end parts, it is possible to readily form a backflow preventing cut.
Furthermore, when the direction in which the cut extends is inclined so as to form an angle ranging from 15 to 165 degrees with respect to the direction connecting the first and the second end parts, namely, the direction of blood flow in the internal channel, an opening area is increases when the corresponding portion is open. Consequently, the blood will flow smoothly via the opening, and the blood flow resistance will be reduced. Therefore, even when the backflow preventing member is used, it is possible to prevent the blood sampling time from being undesirably extended.
In the situation that the cut extends in the direction that is perpendicular to the direction connecting the first and the second end parts, when blood is about to backflow from the second end part toward the first end part, the cut part is more securely closed by backflow force. Therefore, it is possible to prevent backflow from occurring more effectively.
In the above backflow preventing member, when the part functioning as a hinge during opening/closing achieved by the cut has smaller thickness than the remaining part of the backflow preventing member, the cut will securely open only with application of a relatively small pressure, so that rapid blood sampling is realized. Furthermore, by making only the hinge part thinner, the area of the part opposing via the cut is large enough. Therefore, even if the cut part is closed while the opposite parts slightly misaligned, the cut can be securely closed.
According to the luer adapter of the present invention, in the luer adapter having a hollow needle used for piercing a plug member of a blood sampling tube and a hub secured to one end of the hollow needle, the hub has the backflow preventing structure configured in accordance with the present invention, and the hollow needle is communicated with the second end part side of the internal channel of the backflow preventing structure. Therefore, it is possible to securely prevent backflow in the luer adapter by the backflow preventing structure of the present invention, and to provide a luer adapter equipped with a backflow preventing structure at low cost without significantly increasing the number of components.
According to the blood sampling needle of the present invention, in a structure having a hollow needle with one end to be inserted into a blood vessel or container containing blood for sampling blood, and a hub to which one end of the hollow needle is secured, the hub has the backflow preventing structure configured according to the present invention, and the hollow needle is communicated with the first end part side of the internal channel.
Therefore, when blood flows from the second end part side toward the first end part side, namely flows back, the cut provided in the backflow preventing structure is securely closed by force of the blood flow, so that backflow is securely prevented. In addition, since the backflow preventing structure of the present invention can be obtained without causing significant increase in number of process steps and components, the blood sampling needle having the above backflow preventing structure can be provided at low cost.
According to the blood sampling holder of the present invention, in the blood sampling holder including a holder main body formed with an opening for insertion of a blood sampling tube at one end side and closed at the other end side; a hub provided on the other end side; and a hollow needle for piercing a plug member of the blood sampling tube, the hub has the backflow preventing structure configured according to the present invention, and the hollow needle is communicated with the second end part side of the internal channel of the backflow preventing structure of the blood sampling part. Therefore, it is possible to securely prevent backflow by means of the backflow preventing structure, and to prevent backflow without causing a significant increase in number of components. Therefore, it is possible to provide an inexpensive and safe blood sampling holder.
The shape of the cut is not limited to those described above. Examples are shown in attached drawings. For these shapes, the cut may also be formed at only one position or at plural positions. Further, the cut may be rotated axially at any angle. The cut amount is appropriately adjusted to optimum depending on the shape and number of cut.
When the blood sampling holder of the present invention further includes a blood sampling hollow needle having one end secured to the hub and the other end extending outside the holder, and the blood sampling hollow needle is communicated with the first end part side of the internal channel of the backflow preventing structure, it is possible to provide a blood sampling holder having excellent safety in which the hollow needle is integrated with the hollow needle provided for connection to the blood sampling tube according to the present invention.
a) and 1(b) are views for explaining a blood sampler according to a first embodiment of the present invention, wherein
a) and 2(b) are respectively, a perspective view of a backflow preventing member used in the first embodiment, and a perspective view in a state that a cut is opened by blood.
a) and 5(b) are partially cutaway front section views respectively showing the state in which blood is collected while the cut of the backflow preventing member according to the first embodiment is open and the state that the cut is blocked by backflow.
a) and 9(b) are schematic front section views for explaining a luer adapter according to a fourth embodiment of the present invention.
a) and 10(b) are schematic front section views for explaining a luer adapter according to a fifth embodiment of the present invention.
a) and 12(b) are partially cutaway views for explaining an alternate example of the luer adapter shown in
a) and 13V are partially cutaway views for explaining an alternate example of the luer adapter shown in
a) to 16(c) are schematic section views showing alternate examples of shape of cut in the backflow preventing member according to the present invention.
The present invention will be more apparent by referring the following explanation of concrete embodiments of the present invention taken together with the attached drawings.
a) and 1(b) are a front view and a front section view for explaining a blood sampling holder equipped with a backflow preventing structure of a blood sampler according to one embodiment of the present invention.
A blood sampling holder 1 shown in
A hollow needle 4 is secured to the hub 3 in such a manner that it is in communication with the second end part 3c of the internal channel 3a. The hollow needle 4 is arranged such that a needlepoint 4a at its distal end extends inside the holder main body 2. On the periphery of the hollow needle 4, a rubber sheath 5 is attached.
The hollow needle 4 is provided for piercing a plug member of a vacuum blood sampling tube. To be more specific, in conducting a vacuum blood sampling, by piercingly inserting the hollow needle 4 through a plug member, communication between the interior of the blood sampling tube and the above internal channel 3a, and therefore communication between a later-described blood sampling needle and a blood vessel are established.
The rubber sheath 5 is made of a rubber material having flexibility, and provided for preventing blood from leaking outside at the needlepoint 4a at the distal end of the hollow needle 4. When the plug member is pierced with the needlepoint 4a, the rubber sheath 5 is also pierced with the needlepoint 4a. As a result, the rubber sheath 5 comes into close contact with the outer circumferential face of the hollow needle 4, so that it is possible to prevent blood from leaking outside the blood sampling tube. It is to be noted that the rubber sheath 5 is not necessarily provided.
The internal channel 3a contains a backflow preventing member 6. As shown in an enlarged scale in
In the present embodiment, the backflow preventing member 6 has a substantially circular tubular shape, and has near its open end a thickened part 6a having an extended outer diameter. The diameter of a main body part 6b that is downwardly subsequent to the thickened part 6a is designed to be relatively small, and the main body part 6b is formed with a cut 6c. The cut 6c is provided so as to penetrate through a lateral surface of the backflow preventing member 6. The cut 6c may be readily formed by simply cutting the backflow preventing member 6 formed of a material having rubber elasticity with a cutter or the like, for example.
In the present embodiment, the cut 6c is formed so as to extend in the direction perpendicular to the longitudinal direction of the backflow preventing member 6.
Referring again
The backflow preventing member 6 is inserted and pressed into the internal channel 3a through a closed portion on the opposite side of the thickened part 6a. As a result, the outer circumferential surface of the thickened part 6a comes into close contact with the inner circumferential surface of the internal channel 3a.
Accordingly, the backflow preventing member 6 can be secured within the internal channel 3a only by insertion into the internal channel 3a.
The cut 6c is situated at a position closer to the second end part 3c than the part where the backflow preventing member 6 is secured to the internal channel 3a, or than the thickened part 6a in the present embodiment. Since the cut 6c is formed in a direction perpendicular to the longitudinal direction of the backflow preventing member 6, it also extends in a direction perpendicular to the direction connecting the first end part 3b and the second end part 3c of the internal channel 3a.
Examples of the rubber elastic material forming the backflow preventing member 6 include synthetic rubbers such as silicone rubber, butyl rubber, and thermosetting elastomer, as well as natural rubber.
Through explanation of a blood sampling method using the blood sampling holder 1 of the present embodiment, an operation and an effect of the backflow preventing structure equipped with the above backflow preventing member 6 will be explained.
Prior to blood sampling, a hollow needle 11 is attached to the hub 3 of the blood sampling holder 1 as shown in
For blood sampling, a tourniquet is wore on an arm of a subject whose blood is to be sampled. After securing the hollow needle 11 on the hub 3 of the blood sampling holder 1, the needlepoint 11a of the hollow needle 11 is inserted into a blood vessel. Then as shown in
The backflow preventing member 6 has a bottomed circular tubular shape that opens toward the first end part. The cut 6c is opened by the pressure of blood that is guided thereto as shown in
When the inner pressure of the blood sampling tube 21 comes into equilibrium with the inner pressure of the blood vessel, the blood sampling completes. Then, blood sampling can be finished by drawing the blood sampling tube 21 out of the blood sampling holder 1. In such a situation, if the tourniquet is erroneously removed in first, and the blood collected in the blood sampling tube 21 is about to flow back due to a sudden pressure drop in the blood vessel, the backflow is securely prevented by the backflow preventing member 6.
That is, as shown in
Therefore, by using the blood sampling holder 1 of the present invention, it is possible to securely prevent blood from flowing back because of provision of the backflow preventing structure within the hub. According to this backflow preventing structure, all that is needed is to arrange the backflow preventing member 6 made of a material having rubber elasticity within the internal channel 3a, and the backflow preventing member 6 can be formed only by forming the cut 6a in the rectangular circular tubular body. Therefore, increases in processing steps and in number of components are difficult to be caused.
In the above embodiment, the backflow preventing structure is provided in the hub 3 that is formed in integration with the main body 2 of the blood sampling holder 1. However, the backflow preventing structure of the present invention may be applied to various types of blood samplers. This will be explained with reference to
In a second embodiment shown in
As is the case of the internal channel 3a in the first embodiment, the backflow preventing member 6 is pressed into the internal channel 33a, and the thickened part 6a of the backflow preventing member 6 is in close contact with an inner circumferential surface of the internal channel 33a in a liquid tight manner.
In the present embodiment, by inserting the luer adapter 32 into the blood sampling holder 31 from the hollow needle 34 side, and screwing the male screw 33d into the female screw 31c, the luer adapter 32 is secured to the blood sampling holder 31. As a result, a structure similar to that of the blood sampling holder 1 of the embodiment shown in
Therefore, by attaching the hollow needle 11 shown in
In this manner, the backflow preventing structure of a blood sampler may be provided in the luer adapter 32 having the hollow needle 34 that pierces a plug member of a blood sampling tube.
That is, the blood sampling needle 41 has a hub 43. The hub 43 has an internal channel 43a. The internal channel 43a is formed in the direction connecting a first end part 43b and a second end part 43c. The internal channel 43a contains a backflow preventing member 6. The backflow preventing member 6 is configured similarly to the backflow preventing member 6 shown in
To one end of the hub 43, a proximal end of a first hollow needle 44 is secured. A needlepoint 44a of the first hollow needle 44 is a portion that is to be inserted into a blood vessel, and the proximal end is in communication with the internal channel 43a on the first end part 43b side. On the other hand, to the other end of the hub 43, a proximal end of a hollow needle 45 is secured, and the proximal end is in communication with the second end part 43c of the hollow needle 43. The hollow needle 45 is used in such a manner that it is pierced toward a plug member of a blood sampling tube from the side of a needlepoint 45a.
Therefore, it can be seen that the blood sampling needle 41 has a structure that is obtained by securing the blood sampling needle 11 shown in
a) and 9(b) are schematic front section views showing a luer adapter 51 according to a fourth embodiment of the present invention, and
The luer adapter 51 shown in
A significant difference between the luer adapter 51 and the luer adapter 32 is that a rubber sheath 52 is provided so as to cover the hollow needle 34. The rubber sheath 52 is made of a material similar to that of the rubber sheath 5 shown in
Also in the luer adapter 51, the backflow preventing member 6 is pressed into the hub 33, and the backflow preventing member 6 is formed with the cut 6c. Therefore, the luer adapter 51 may be used similarly to the luer adapter 32 described above.
However, the backflow preventing member 6 may possibly be secured while being inclined relative to the extending direction of the internal channel as shown in
In order to solve such a problem, it is preferable to secure the backflow preventing member 6 in a proper orientation within the hub 33 as shown in
In a luer adapter 61 according to the fifth embodiment shown in
In the backflow preventing member 6 of the luer adapter 6l shown in
Therefore, when the backflow preventing member 6 is secured aslant, and the hinge part 6d of one of the cuts 6c is in abutment with the inner wall of the hub 33, as shown in
Therefore, as is the case with the luer adapter 61 of the fourth embodiment, in the backflow preventing member of the present invention, the backflow preventing member 6 is preferably provided with the plural cuts 6c, 6f.
More preferably, when the plural cuts cut 6c, 6f are provided as in the above embodiment, a hinge part of at least one cut and a hinge part of at least other one cut are provided in circumferentially different positions of the backflow preventing member 6. However, even when the hinge parts are provided in the circumferentially same positions of the backflow preventing member 6, one of the hinge parts can be securely separated from the inner wall of the hub on the condition that the plural cuts are provided at different height positions.
Therefore, the hinge parts of the plural cuts are not necessarily provided in circumferentially different positions of the backflow preventing member 6.
In the fourth embodiment, two cuts 6c, 6f are provided, however, three or more cuts may be provided.
Therefore, as is the case with the luer adapter 62 according to the sixth embodiment, it is preferred that a dimension along the extending direction of the internal channel, of the part where the outer circumferential surface of the backflow preventing member 6 is brought into close contact with the inner circumferential surface of the internal channel is set to at such a length that restricts the inclination as described above.
In the aforementioned embodiment, the blood sampling holder has a circular tubular shape, however, it may be other tubular shapes such as rectangular tubular shape.
The cut 6c formed in the backflow preventing member 6 should extends in the direction that intersects with the direction connecting the first and the second end parts, but not necessarily be provided in the direction perpendicular to the direction connecting the first and the second end parts as is the case of the above embodiment. Nevertheless, the cut 6c is preferably formed in the direction perpendicular to the direction connecting the first and the second end parts of the internal channel from the view point of securely closing the cut 6c by backflow.
a) and 12(b) are partially cutaway front section views showing an alternate example of the luer adapter 51 shown in
In this alternate example, the extending direction of the cut 6c is inclined at an angle of 60 degrees with respect to the direction connecting the first and the second end parts, i.e. the direction in which the internal channel extends. Appropriate inclination at an angle ranging from 15 degrees to 165 degrees as well as at an angle of 60 degrees will realize the effect of increasing the opening area of the part where the cut 6c opens.
a) and 13(b) are partial cutaway front section views showing a luer adapter according to a further alternate example of the luer adapter 51.
According to a luer adapter 54 shown in
As shown in
The amount of cut formed in the backflow preventing member 6, that is, the size of the cross section of the cut part formed by cutting may be adjusted depending on hardness and thickness of the backflow preventing member. A preferred example of such size of the cut 6c will be explained with reference to
Taking as a standard the case where an elastic material formed of butyl rubber having a Shore A hardness ranging from 40 to 45, and a thickness of about 0.8 mm is used, it is preferred that the cut 6c has a cut part which is one-half or more of a traverse section of the backflow preventing member 6 as shown in
According to the “Standard for sterile injection syringe” announced by Ministry of Health, Labor and Welfare of Japan, in the luer adapter 51 as shown in
In general, the backflow preventing member 6 has a thickness ranging from 0.1 to 1.0 mm in the vicinity of the cut 6c. If the thickness is less than 0.1 mm, when it closes during a backflow preventing operation, the contacting surface in the cut 6c misaligns, which may hinder prevention of backflow. To the contrary, if the thickness is more than 1.0 mm, the force necessary to close for prevention of backflow is large, so that there is a fear that closing occurs before the sampling amount of blood reaches a predetermined amount. In practice, when an outer diameter of a luer adapter W2 is 4.0 mm, an inner diameter W3 is 3.0 mm, and when it is desired that a gap between the inner circumferential surface of the hub 33 and the backflow preventing member 6 is 0.5 mm, the outer diameter of the backflow preventing member 6 should be 2.0 mm. Therefore, it is practically difficult to provide a backflow preventing member 6 having a thickness larger than 1.0 mm according to the above dimensional relationship.
The facts that the inner diameter of the backflow preventing member 6 is preferably 0.2 mm or larger, and that the thickness is preferably in the range of 0.1 to 1.0 mm premise the luer adapter in conformance with the aforementioned “Standard for sterile injection syringe” announced by Ministry of Health, Labor and Welfare of Japan. When dimensions of a luer adapter and a blood sampler are different from those described above, the above dimensions also change accordingly. Next, concrete test examples producing luer adapter 51 of various dimensions will be explained.
A luer adapter having a dimension in conformance with the “Standard for sterile injection syringe” announced by Ministry of Health, Labor and Welfare of Japan was prepared.
To be more specific, a backflow preventing member 6 having an overall length L of 6.0 mm, an outer diameter W4 of 2.0 mm, an inner diameter W1 of 1.0 mm, and a thickness of 0.5 mm was set with respect to a hub having an inner diameter of 2.5 in the hub 33 shown in
Example 1 was followed except that the part where the cut 6c of the backflow preventing member was provided had an outer diameter W4 of 1.8 mm, an inner diameter W1 of 1.2 mm, and a thickness of 0.3 mm.
Example 1 was followed except that the part where the cut 6c of the backflow preventing member 6 was provided had an outer diameter W4 of 1.8 mm, an inner diameter W1 of 1.2 mm, and a thickness of 0.3 mm, and that the cut 6c was inclined at an angle of 45 decrees with respect to the direction connecting the first and the second end parts which is the extending direction of the internal channel.
Example 1 was followed except that the backflow preventing member 6 had an outer diameter W4 of 1.8 mm, an inner diameter W1 of 1.2 mm, and a thickness of 0.3 mm, and that two cuts were provided that extend horizontally in different height positions, i.e., extend in the direction perpendicular to the extending direction of the internal channel.
A luer adapter having a hub as same as Example 1 except that the backflow preventing member was not inserted was prepared.
With respect to the luer adapter of Examples 1 to 4 and Comparative example, a backflow amount and an amount of absorbed water were evaluated in the following manner. The results are shown in Table 1.
Backflow amount: As shown in
Weight of collected water: A test tube with a capacity of 7 cc was sealed with a rubber plug under a reduced pressure, and a vacuum blood sampling tube was prepared. The above luer adapter was attached to the blood sampling holder. A burette was filled with water, and a tub of the burette was opened. The water in the burette through which a spring clip is passed was made to flow into a silicone tube connected to the burette, and the water flow was stopped by clipping at a burette scale of 0.
A hollow needle outside the blood sampling holder to which the luer adapter was attached was pierced into a silicone tube, and a needlepoint was placed within the silicone tube. Then on the side of the opposite hollow needle of the blood sampling holder, the aforementioned blood sampling tube was inserted, and water absorption was started by a pressure difference. After the interior of the blood sampling tube was filled with water, it was left for at least one minute. Thereafter, the highest water surface of the burette was made coincidence with the level of the liquid surface of the blood sampling tube at an accuracy of ±0.1 mL, and then an amount of absorption was determined.
As is apparent from Table 1, Examples 1 to 4 securely prevent backflow in comparison with Comparative example.
Also the amount of water absorption falls within the range of 95 to 97.5% by weight based on 100% for Comparative example, and reduction in amount of water absorption resulting from insertion of the backflow preventing member 6 was not observed.
In the above Examples, a linear cut is formed in the backflow preventing member 6, however, the shape and number of cut provided in the backflow preventing member according to the present invention may be appropriately changed. Such alternate examples are exemplarily shown in
| Number | Date | Country | Kind |
|---|---|---|---|
| 2004-146985 | May 2004 | JP | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/JP2005/008895 | 5/16/2005 | WO | 00 | 11/14/2006 |
