The disclosed subject matter generally pertains to blood lines having useful application in an extracorporeal circuit. More specifically, the subject matter pertains to a connector and a blood line.
As illustrated in
According to one aspect, a blood line assembly comprises a first tube possessing an end, a second tube comprised of a second tube body possessing an end and two branch tubes branching from the end of the second tube body, with each of the two branch tubes possessing an end, and a connector comprising first, second and third connections each provided with a through passage, with the end of the first tube being removably fitted to the first connection, and the end of each of the branch tubes being removably fitted to the second and third connections respectively. The first tube and the branch tubes are removable from the respective connections of the connector for subsequent connection to respective catheters positioned in a patient.
According to another aspect, a connector comprises a connector body possessing a lumen, a plurality of connections provided on the connector body, with each connector possessing a through passage communicating with the lumen of the connector body and with each of the connections being adapted to be removably connected to a respective tube to communicate a lumen of each tube to the lumen of the connector body, and opening-and-closing means for opening and closing the passages of all of said plurality of connections together. The opening-and-closing means is operable to selectively position the connector in a communication state in which the passages of all of said plurality of connections are in communication with the lumen and a non-communication state in which the passages of all of said plurality of connections are blocked from communicating with the lumen.
In accordance with a further aspect, a method of using a blood line comprises connecting a blood line assembly to a source of priming liquid. The blood line assembly comprises a connector, a first tube and a second tube, with one of the first and second tubes being comprised of a tube body and two branch tubes branching from the tube body, and the connector comprising first, second and third connections each provided with a through passage, with the first tube being removably fitted to the first connection and each of the branch tubes being removably fitted to the second and third connections respectively. The method also comprises introducing the priming liquid from the priming liquid source into the first tube so that the priming liquid in the first tube flows into the second tube by way of the connector, disconnecting the first tube from the first connection and disconnecting each of the branch tubes from the second and third connections respectively, and connecting the first tube and the branch tubes to a respective catheter positioned in a patient.
With the blood line assembly, connector and method disclosed here, it is possible to provide a blood line that is relatively easy to prepare for extracorporeal circulation of blood without the need for cutting tubing.
As shown in
In the extracorporeal circuit 1, a blood reservoir 102, a pump 101 and an oxygenator 104 are arranged in that order from the upstream end, thus being connected in a line through several tubes 113, 114. This arrangement of medical devices 102, 113, 101, 114, 104 are collectively identified as 2′ in
In the extracorporeal circuit 1 thus arranged, the blood from the patient enters the blood reservoir 102 from the second tube 4, from which the blood is sent by the pump 101 to the oxygenator 104 where oxygen is added, and then the oxygenated blood is returned to the patient.
The first tube 3 is formed as an elongated tubular element (tube) possessing flexibility. The first tube 3 has a base 32 connected to a blood outlet port of the oxygenator 104.
During extracorporeal blood circulation, the tip 31 (see
As illustrated in
By virtue of the first label 7, the first tube 3 is able to be connected, rapidly and positively to the catheter 10a previously positioned in the patient during set-up of an extracorporeal circuit by connecting the blood line 2 with the patient. Thus, the first tube 3 (blood line 1) is relatively easy to handle and appropriately connect.
The material forming the first tube is not particularly limited. As an example, the material can be a flexible polymeric material, e.g., a non-rigid polyvinyl chloride.
The second tube 4 comprises a second tube body 43 and two branch tubes 41, 42 that branch from the second tube body 43 through a bifurcation 44 provided at the tip of the second tube body 43. The second tube body 43 is formed as an elongated tubular element (tube) which possesses flexibility. The base end of the second tube body 43 is connected to the blood reservoir 102 as shown in
The bifurcation 44 at the tip of the second tube body 43 is preferably V-shaped or Y-shaped. Through the bifurcation 44, the second tube body 43 communicates with each of the branch tubes 41, 42. The branch tubes 41, 42 are each formed as an elongated tubular element (tube) possessing flexibility.
During extracorporeal blood circulation, the tip 411 (see
During extracorporeal blood circulation, the tip 421 (see
As shown in
The tip 411, 421 of each branch tube 41, 42 is provided with a second label (marking) 8 specifying that the tube is the second tube or is for use as a venous line as shown in
By virtue of the second label 8, when the blood line 2 is connected to the patient during set-up of an extracorporeal circuit, the branch tubes 41, 42 are able to be relatively rapidly and positively connected to the catheters 10b, 10c respectively previously positioned in the patient. Thus, the second tube 4 is relatively easy to handle and appropriately connect.
As shown in
By making the lengths L3, L4 equal, the first and second tubes 3, 4 are less likely to slacken when bundled together. If the lengths L3, L4 differ from one another and the first and second tubes 3, 4 are bundled together, a slackening can result which degrades the appearance. In addition, should a tube kink occur, it is possible that a local decrease of blood-passage cross-sectional area could arise, making it quite difficult to carry out sterilization due to non-transmission of the sterilizing gas.
The material forming the second tube body 43 (second tube element), inclusive of the bifurcation 44, and the branch tubes 42, 43 is not limited. By way of example, the same material as that used to fabricate the first tube can be employed.
When the blood line 2 is packaged in the package 6 together with the connector 5, and during priming, the connector 5 is preferably attached to the first tube 3 and to the branch tubes 41, 42 of the second tube 4. After priming, and before connecting the first and second tubes 3, 4 to the respective catheters 10a, 10b, 10c, the connector 5 is removed from the first and second tubes 3, 4.
The blood line 2 is received in (packaged) in the package 6 together with the connector 5 as shown in
By virtue of this packaging arrangement, the first and second tubes 3, 4 can be easily taken out of the package 6 by holding the connector 5 and pulling it in the direction of the arrow shown in
As shown in
As shown in
In the illustrated embodiment, the first cylinder 50 has a shell or wall that is cylindrical in form. The shell or wall of the first cylinder 50 need not be cylindrical in form, but may alternatively configured such a polygonal cylindrical form, e.g., quadrilateral, hexagonal in cross-section.
As mentioned, the end of the first cylinder 50 opposite the closed end is open in that it is provided with an opening 503. The inner peripheral surface of the first cylinder 50 in an area adjacent the opening 503 is provided with a groove 501 that is ring-shaped or annular in form. An O-ring (ring-formed resilient member) 55 is positioned in the groove 501. The O-ring 55 is adapted to closely contact the outer peripheral surface of the second cylinder 54 and the outer peripheral surface of a connection 562 of a manipulator 56, described in more detail below. This helps ensure liquid-tightness at the inside of the connector 5 (lumen 500). The O-ring 55 maintains the liquid-tightness in the connector 5 regardless of the displacement or amount of movement of the second cylinder 54 and the connection 562 of the manipulator 56.
The material forming the O-ring 55 is not necessarily limited, though is preferably a resilient material, for example natural rubber or isoprene rubber.
The first cylinder 50 is preferably made substantially transparent (transparent and colorless, transparent and colored, or semi-transparent). This permits visual observation of the tip of the second cylinder 54 and the position of the through-holes 541, 542, described in more detail below, through the first cylinder 50. This helps facilitate the change-over of the connector 5 between a communication state, as shown in
As mentioned above, the shell of the first cylinder 50 is provided with three plugs or connectors 51, 52, 53 that are preferably formed integrally and in one-piece with the first cylinder 50. The plugs 51, 52, 53 are arranged intermittently on the first cylinder 50, meaning that they are spaced apart from one another at equal intervals along the lengthwise or axial extent of the first cylinder 50.
As shown in
The plugs 51, 52, 53 are each cylindrical in form, having an outer diameter that gradually decreases upward. In the illustrated embodiment, all of the plugs 51, 52, 53 protrude or extend in the same direction (i.e., upward as seen with reference to
By virtue of the configuration and positioning of the plugs 51, 52, 53, pulling the connector 5 toward the tip (leftward) in
As shown in
The first cylinder 50 is also provided, in the neighborhood of the plugs 52, 53, with respective second labels (markings) 8 similar to the second labels 8 on the branch tubes 41, 42. These labels can specify the tubes connected respectively to the plugs 52, 53, as the second tube(s) 4. Accordingly, when forming an extracorporeal circuit by connecting the blood line 2 with the patient, upon removing the connector 5, the branch tubes 41, 42 separated from the connector 5 can be connected, relatively rapidly and positively, to the respective catheters 10b, 10c previously positioned in the patient.
The plugs 51, 52, 53 are each provided with a respective through passage 510, 520, 530. The passages 510, 520, 530 open to and communicate with the lumen 500 of the first cylinder 50.
The second cylinder 54 is slidably received in the first cylinder 50 for sliding movement in the lengthwise direction of the first cylinder 50.
The second cylinder 54 is constructed as bottomed cylindrical member that is closed at one end (the base end) and open at the opposite end. The second cylinder 54 has a cylindrically shaped shell or wall similar to the first cylinder 50. The outer diameter of the second cylinder 54 is equal to or somewhat smaller than the inner diameter of the first cylinder 50.
The shell or wall of the second cylinder 54 is provided with two through-holes 541, 542 that are spaced apart from one another along the lengthwise direction of the second cylinder 54. The center-to-center distance between the through-holes 541, 542 is equal to the center-to-center distance between the passages 520, 530 in the connections or plugs 52, 53. The length of the second cylinder 54 is less than the length of the lumen 500 of the first cylinder.
This construction of the second cylinder 54 provides opening-and-closing means to open and close the passages 510, 520, 530 all together.
More specifically, as shown in
When the second cylinder 54 is moved toward the tip relative to the first cylinder 50 (i.e., toward the left in
As shown in
The convex pieces 544, 544 are respectively received in the grooves 502, 502 when the second cylinder 54 is positioned in the first cylinder 50 (i.e., the assembled state of the connector 5). By virtue of the positioning of the convex pieces 544, 544 in the grooves 502, 502, the convex pieces 544, 544 are guided in the respective grooves 502, 502 when the second cylinder 54 is slidably moved relative to the first cylinder 50. This can help prevent the second cylinder 54 from rotating relatively to the first cylinder 50.
In this manner, the grooves 502, 502 and the convex pieces 544, 544 serve as rotation preventing means that prevents the second cylinder 54 from rotating relative to the first cylinder 50. It is to be recognized that other forms of the rotation preventing means are possible. For example, the first and second cylinders 50, 54 can be made polygonal in cross-section to form rotation preventing means.
In the communication state, the second cylinder 54 is in a position closest to the tip end side of the first cylinder as shown in
As mentioned, the base end of the second cylinder 54 is provided with the manipulator 56. The manipulator 56 is mushroom-shaped comprising a grip (head) 561 for fingers to grasp and a connection 562 connecting the grip 561 to the second cylinder 54.
The connection 562 is configured as a cylindrical member having an outer diameter equal to the outer diameter of the second cylinder 54, it being understood that the term equal encompasses near equality. The outer surfaces of the second cylinder 54 and the connection 562 thus form together a continuous outer surface.
As shown in
By visually confirming the position of the label 563, it is possible to positively know (visually confirm) the state of the connector 5, i.e., whether the connector 5 is in the communication state or the non-communication state.
The material forming the various parts of the connector 5 (i.e., the first cylinder 50, the plugs 51, 52, 53 and the second cylinder 54) is not limited. By way of example though, the material can be resin, e.g. polyvinyl chloride, polyethylene or polypropylene.
A method of connecting the blood line 2 with the catheters 10a, 10b, 10c positioned in the patient is as follows.
Initially, with the blood line assembly (the blood line 2 together with the connector 5) packaged in the package 6 as shown by way of example in
Once priming is completed, clamps (forceps) are respectively arranged around the tip 31 of the first tube 3, the tip 411 of the branch tube 41 and the tip 421 of the branch tube 42. This prevents the priming liquid from being discharged out of the tubes when the connector 5 is removed.
Thereafter, the connector 5 is removed from the first tube 3 and the branch tubes 41, 42. Prior to removing the tubes 3, 41, 42 from the connector 5, the second cylinder 54 is moved toward the base of the first cylinder 50 relative to the first cylinder 50, thus placing the connector 5 in the non-communication state shown in
In an operation field, the catheters 10a, 10b, 10c are positioned in the patient. Upon removing the connector 5 from the tubes 3, 41, 42, the tip 31 of the first tube 3 and the tips 411, 412 of the branch tubes 41, 42 are able to be connected to the respective catheters 10a, 10b, 10c.
Then, the catheters 10a, 10b, 10c are respectively connected to the tip 31 of the first tube 3, the tip 411 of the branch tube 41 and the tip 421 of the branch tube 42. After this, the clamps applied to the tips of the tubes are removed.
The connector 5 described above and illustrated in the drawing figures is relatively simple in structure and can be relatively easily changed from the communication state to the non-communication state by a single-action manner. Advantageously, this does not impose a significant burden on the perfusionist. That is, the operation can be performed in a relatively simple way.
In this manner, in the blood line 2 disclosed here, the first and second tubes 3, 4 are able to be placed in a state connectable respectively with catheters 10a, 10b, 10c by merely removing the connector 5 from the first and second tubes 3, 4. In addition, the subsequent connections to the catheters 10a, 10b, 10c are relatively easy to perform, thus permitting a relatively rapid transition to extracorporeal circulation. Thus, the blood line 2 can be handled quite easily.
The description which follows primarily discusses features associated with the second embodiment of the connector and blood line that differ from the first embodiments described above. Features in the second embodiment of the connector that are the same as those in the first embodiment are identified by the same reference numerals and a detailed description of such features is not repeated. The second embodiment of the connector 5A differs from the first embodiment primarily in that the second cylinder 54′ can be moved by rotation.
In the connector 5A shown in
In this embodiment, the communication state is obtained by aligning the through-holes 541, 542, 543 with respective ones of the passages 520, 530, 510 as shown in
As shown in
The outer surface of the second cylinder 54′ is provided with a circumferentially extending and outwardly projecting convex portion or projection 546. The convex portion 546 has a vertical cross-sectional form corresponding to the vertical cross-sectional form of the concave 504.
In the connector 5A, the convex portion 546 of the second cylinder 54′ is fit or positioned in the concave portion or groove 504 of the first cylinder 50. By virtue of this arrangement, when rotating the second cylinder 54′ relative to the first cylinder 50, the second cylinder 54′ is prevented from unintentionally moving in the lengthwise direction relative to the first cylinder 50. In this way, the concave portion 504 and the convex portion 546 serve as movement preventing means that prevents the second cylinder 54 from axially moving relative to the first cylinder 50.
As shown in
In the illustrated example, the first and second cylinders 50, 54′ have respective shells or walls that are cylindrical in form. However, the first and second cylinders can alternatively be a polygonal cylindrical form, e.g., octagon, in cross-sectional form. This can provide a click feeling while rotating the second cylinder 54 relative to the first cylinder 50, thus providing an indication that rotation is effected positively.
The connector 5A according to this second embodiment provides benefits and advantages similar to those described above in connection with the connector 5 of the first embodiment. In addition, a rotation-angle regulating means can be provided to regulate the rotation angle of the second cylinder 54′ relative to the first cylinder 50.
The connector 5A′ shown in
By positioning the communication passage 581 underneath the passages 510, 520, 530, the connector 5A′ is placed in a communication state, as shown in
During priming of the blood line, the connector 5A′ requires a smaller amount of priming liquid than that associated with using the connector 5A of the second embodiment.
The connector 5B in this embodiment is similar to those of the first, second and third embodiments except that the connector is provided with a grip portion 57. The grip portion 57 constitutes a portion of the connector which is gripped by the user when attaching/detaching the connector 5B to/from the tubes. The grip portion 57 has a rounded exterior surface. This makes it relatively easy to hold the grip portion 57 and hence to attach/detach the connector 5. The grip 57 may also be in a ring form.
The connector 5B of the fourth embodiment can achieve benefits and advantages similar to the connectors 5, 5A of the earlier embodiments.
The combination of the connecter and blood line, as described above and illustrated in the various drawing figures, together form a blood line assembly.
The connector and blood line disclosed here is illustrated and described in connection with the various embodiments. However, the invention is not limited to the disclosed elements, and the structure of the blood line and connector can be varied, and other features can be added.
For example, the connector's connections are not limited to projections or plugs (structured as a convex element), or a male configuration, but may be, for example a concave element providing a female configuration. Also, the connections of the connector are not limited to three in number as two or four (or more) may be provided.
The connector may be provided with state-maintaining means that maintains the connector in the communication or non-communication state.
Also, the connector and the blood line may be a combination of two or more structures (features) from amongst the foregoing embodiments.
The first and second labels may be the same color or different in color. In the described embodiments, the first and second labels are provided on both the first and second tubes and the connectors. However, the connector and blood line are not limited in this regard as they may be placed on only one of those.
Further, the blood reservoir may be replaced with a bubble removing device that removes bubbles from a circuit, and the centrifugal pump may be replaced with a roller pump.
Thus, it is to be understood that the principles, preferred embodiments and other disclosed aspects have been described in the foregoing specification. However, the invention which is intended to be protected is not to be construed as limited to the particular embodiments disclosed. Further, the embodiments described herein are to be regarded as illustrative rather than restrictive. Variations and changes may be made by others, and equivalents employed, without departing from the spirit of the present invention. Accordingly, it is expressly intended that all such variations, changes and equivalents which fall within the spirit and scope of the present invention as defined in the claims, be embraced thereby.
Number | Date | Country | Kind |
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2006-195503 | Jul 2006 | JP | national |
2007-083100 | Mar 2007 | JP | national |