JPS632625B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION In multiple blood bags and the like, it is desirable to provide seals in the tubes between the multiple blood bags that can be opened without initially compromising sterility within the system. This has been accomplished in the past by various types of pointed cannulae located within the tube itself and operated from the outside to penetrate the diaphragm or membrane closing the tube. To open the valve, a ball has also been inserted into the tube between the blood bags so that it can be removed by dropping it from the outside of the tube into the squeeze bag.

Other fracture structures within tubes are known in which a rigid closed-end tube-like structure is ruptured in the middle so that a flow path through the tube is opened by manipulation from the outside of the tube.
See U.S. Pat. No. 4,007,738.

However, these structures have the disadvantage that they cannot be resealed once opened. These structures also present some difficulties in handling and use.

That is, all of the above-mentioned known structures have drawbacks, such as requiring time and effort to attach them to a flexible tube, blood bag, etc., or requiring skill to break open the closure. Therefore, the present invention is suitable for mass production, is easy to attach to a bag or flexible tube, and can be relatively easily broken when opening a valve after assembly.
The object is to provide valve means within a flexible tube.

In accordance with the present invention, a flexible tube is provided for connecting tubes between blood bags or in other desired applications where it is desired to valve fluid flow within a flexible tube without contacting the interior of the tube. A valve type seal for the sex tube is provided. The valve of the present invention is preferably resealable, allowing flow through the tube to be reclosed and reopened when desired.

In this invention, a valve means is provided which includes a tube-like member having a closed end in a flexible tube. An elongated generally rigid member is attached to the outside of the closed end and located within the flexible tube.

A weakening means is provided for folding the elongate member from outside the flexible tube to permit opening of the closed end by manual manipulation of the elongate member. The weakening means is an annular thin-walled web connecting the elongated rigid member together to the outside of the closed end and can be formed, for example, by providing an annular groove in the closed end of the tubular member. The elongate member is also preferably adapted to fit in a sealing relationship within the tube-like member so that the valve can be resealed after opening.

The elongate member may be provided with vanes along its length to define a fluid flow path therealong, so that the member does not impede flow within the tube. Preferably, the vanes are of unequal length and a pair of opposing vanes extend rearwardly from the central end of the rigid member. The flexible tube surrounding the rigid member is then positioned to receive and resiliently retain the opposing longer vane after the weakening means has been destroyed and the rigid member has separated from the tubular member. Preferably, it has a conical portion. This maintains the valve in the open position to prevent inadvertent reclosure due to movement of the rigid member interfering with the tubular member.

In the drawings, FIG. 1 is a plan view of a multi-layer blood bag employing the present invention.

FIG. 2 is an enlarged view of the valve of the invention seen in FIG. 1, partially in longitudinal section.

FIG. 3 is a further enlarged view of a portion of FIG. 2, partially in section, showing the closed end of the tubular member and a portion of the elongate member in its original condition;

FIG. 4 is an enlarged view similar to FIG. 3 showing the same structure after the valve of the present invention has been opened and then resealed.

FIG. 5 is an enlarged view similar to FIG. 3, but with a slightly different structure.

FIG. 6 is a cross-sectional view taken along line 6--6 of FIG.

FIG. 7 is an enlarged partially sectional view showing another embodiment of the valve of the present invention, which can be used in the system of FIG. 1.

FIG. 8 is an enlarged view similar to FIG. 7 showing the valve held in the open position of the rigid member.

FIG. 9 is a partially cut away perspective view of the tubular member and rigid member assembly of the present invention.

1-6, the present invention, in a known manner, comprises two blood bags 10, 12 connected together by a length of tube 16.
Shown on the individual bag system. The invention also applies to three-bag and four-bag systems, if desired, or to systems for use in the medical field and elsewhere where it is desired to be able to control the valve operation inside a flexible tube from the outside. It is of course intended that it be used.

Blood bag 10 includes a conventional blood donor tube 22, only a portion of which is shown, similar to those commercially available today, and an access port 24.
and have.

In accordance with the present invention, valve means 26 extends through the heat-sealed wall 28 of the blood bag and is maintained in sealed flow communication with the blood bag 10, as shown in detail in FIG. It is provided.

As previously mentioned, the valve means 26 includes a tube-like member 30, which is shown to be a member that extends through and is retained by a heat-sealed portion of the blood bag. ing. The tubular member 30 is preferably formed from a rigid plastic and integrally molded with an elongated generally rigid member 32 to form a unitary member.

Tubular member 30 has a closed end 34 . An elongated rigid member 32 is mounted outside the closed end and located within the flexible tube 36 as shown in FIG.

The flexible tube 36 is sealed to the tubular member 30 at one end 38 by conventional solvent or heat sealing and crimped at the other end 40 in a conventional manner for sealing connection to the narrower diameter tube 16. can do. Thus, as part of the tube 16 which is also flexible, the flexible tube 36 is an elongated generally rigid member 3.
2 to form an enlarged chamber within the flow line that accommodates the flow line.

The enlarged chamber formed by the tube 36 is slightly longer than the elongated member 32 to form a space 42 for withdrawing the elongated member 32 from its integral connection with the tubular member 30. It will be recognized that this can be done.

Elongate member 32 preferably includes a forwardly located tapered portion 44 connected to closed end 34 of tubular member 30 . Tapered portion 44
A weakening means is provided, embodied in FIG. 3, by a tear line 46 extending all the way around the front end and formed in the closed end 34. The tear line is defined by an annular groove of reduced thickness along the tear line 46 formed between the tapered portion 44 and the tubular member 30. Therefore, valve 26
When it is desired to open the tube 36, the user simply grasps the tube 36 between the fingertips and bends or twists the rigid elongated member 32 until a split is created around the tear line 46. Thereafter, the elongated member 32 is moved rearwardly in the manner shown in phantom in FIG. 2 to remove the end 34 of the tube 30 out of the way and open the flow path through the valve. Can be done.

According to a preferred embodiment of the invention, the tapered portion 44 of the elongated member 32 provides a tight obstruction to fluid flow through the tubular member 32, as shown in FIG. 4, when it is desired to reseal the valve of the invention. The dimensions are such that the tapered portion 44 can be pushed into the open end of the tubular member 30 to form a seal. Accordingly, with this structure, the structure that was originally the end 34 of the tube 30 is forced inwardly from the end of the tube 30 as shown.

Thereafter, the elongated member 32 can be manually manipulated to connect or disconnect sealing relationship with the tubular member 30, as desired, to open and close the valve as needed.

Elongated member 32 is provided with a series of radially disposed, longitudinally extending vanes 48 having a cross-shaped cross section to form longitudinal flow passages between the vanes to facilitate fluid flow. It will be done. Also, the diameter of the outer tube 36, when broken from the tube-like member 30, is such that, when broken from the tube-like member 30, unless the member 32 is positioned as shown in FIG. The elongate member 32 is dimensioned to be larger than its maximum transverse dimension so that fluid can easily flow around the member 32.

Referring to FIG. 5, a slightly modified embodiment of the device described above is shown. This embodiment is identical to the embodiment described above except that an annular groove 52 is formed in the end wall 34a of the tubular member 30a. Accordingly, manipulating the elongate generally rigid member 32a in a manner similar to the embodiments described above, the grooves 52 and the weakened areas 46 may be removed somewhat more easily due to the grooves 52 than in the embodiments previously described.
A tear occurs in the annular area near a. This embodiment can be used if desired with particularly strong plastic materials or when the dimensions of the device are large.

Further, the rigid member 32a is the tube-shaped member 30a.
A stop member 54 may be provided to prevent excessive pushing inward.

The structure according to the present invention is easy to mold and has reliability on a mass production basis.

Referring to FIGS. 7-9, there is shown another embodiment of a valve means according to the present invention, which valve means is operable from outside the tube while controlling flow through the tube. It can be used as the valve handle 26 in the two blood bag system of FIG. 1 or in any other desired application.

A blood bag 50 or any other container is connected to a flexible tube 56 by a flat seal 52.
is surrounded and fixed in a sealing relationship and in communication with the inside of the bag. The tube 56 has a relatively large diameter compared to the flow tube 58 and has two pleated heat seals or a
They are commonly joined together by a four-way heat seal 60 of the general type described in US Pat. No. 2,702,036. The junction between tubes 56 and 58 is preferably provided with a conical hole 62 as shown.

A tubular member 64 having a closed end 66 is secured to the inside proximal end of tube 56 in a manner similar to the previously described embodiments. Closed end 66 retains an elongate, generally rigid member 68 in integral relationship therewith for purposes similar to the previously described embodiments. In this particular illustration, lines of weakness similar to lines 46 or 52 are not formed, but the tearing action may occur by folding elongate member 68. The inner wall of the tube-shaped member 64 and the elongated member 6
When a force is applied to the relatively thin area 70 between the solid mass of the tube 56 and the annular area 70 around the member 68, the elongated member 68 from the outside of the tube 56
ruptures due to the operation of , so that the area constitutes a weak line of sight without the need for special grooves.

Elongated, generally rigid member 68 includes a tapered portion 72, as in the previous embodiment, which is inserted into bore 74 of tubular member 64 for resealing after opening, as shown in phantom in FIG. Can be fitted.

The protrusion 76 projects outwardly to prevent over-insertion of the elongate member 68 into the hole 74, making it difficult for the member 68 to be removed from the rear. The protrusion 76 is pressed against the end of the tubular member 64 to prevent further insertion when the member 68 has been inserted to the appropriate depth.

As in the previous embodiment, elongated generally rigid member 68 includes a plurality of vertical vanes 78,80. However, it is desirable that the vanes 80 be unequal in length and longer than the vanes 78, and of sufficient length to exhibit significant spring resiliency.

Thus, when opening the valve manually by bending the generally rigid member 68 to break the weakened area 70, the tube 56 is axially collapsed and then squeezed and expanded again. The member 68 can be manually moved rearwardly until the member 68 is stopped in a tight resilient retention relationship between the vane 80 and the conical hole portion 62.

Therefore, the rigid member 68
8 and 80, allowing the flow of blood or the like to pass longitudinally around the member 68 while remaining in place. This does not involve the risk of forcing the rigid member 68 into an interfering relationship with the bore 74 of the tubular member 64 until the rigid member 68 is released from the retaining relationship with the bore 62 by positive manual operation. allows bidirectional flow of fluid through the valve as desired.

Therefore, the valve of the present invention reliably opens and remains open as shown in FIG. 8 when desired;
After the first opening, by manipulating the exterior of the flexible tube 56 from the outside, resealing can be ensured even after opening.

For most convenient operation, the flexible tube 56 is made very soft and can be bent outwardly as necessary during the process.
The tube 56 can be axially collapsed during manipulation of the generally rigid member 68. In this way, the rigid member can be grasped and moved due to the flexibility of the tube 56.

Also, if desired, because tube 56 is flexible, an external clamp can be used to hold rigid member 68 in the desired open or closed position.

Another variation is to make the small diameter tube 58 slightly thicker and omit the tapered portion 62 so that the vanes 80 project directly into the small diameter tube 58 and remain in the same type of opening position as before. It can also be made to flex somewhat.

The effects of the present invention are as follows. That is, the valve means of the present invention includes tube-shaped members 30, 6.
4 and the rigid members 32, 68 can be integrally manufactured by injection molding of a suitable plastic material,
Moreover, the means can be attached to bags or flexible tubes with a minimum of effort by heat sealing or otherwise, making it suitable for mass production. Further, the valve means of the present invention can be opened from the outside of the flexible tube by using the closed end of the tube-like member as a fulcrum and folding the elongated rigid member by lever action. Opening does not require skill or great strength. Even after the elongated rigid member is separated from the tube-like member, it can be inserted into the tube-like member to reseal the valve means if necessary, and its shape is similar to that of the flexible tube after the valve means is opened. Separate elongated rigid members can also be secured against movement within the flexible tube without impeding fluid flow therethrough.

The above description has been made for illustrative purposes only and is not intended to limit the scope of the invention as defined by the claims.

[Brief explanation of the drawing]

Figure 1 is a plan view of the blood-rich bag, and Figure 2 is the top view of the blood-rich bag.
3 is an enlarged view of a portion of the valve shown in FIG. 2; FIG. 4 is an enlarged view of the valve after resealing; FIG. 5 is an enlarged view of a modified example of the valve; 6 is a cross-sectional view taken along line 6-6 in FIG. 2, FIG. 7 is an enlarged view showing another embodiment of the valve, and FIG. 8 is an enlarged view similar to FIG. 7 with the rigid member remaining in the open position. FIG. 9 is a perspective view of the tubular member and rigid member assembly. 10 and 12 are blood bags, 16 is tube, 2
6 is a valve means, 30 is a tube-shaped member, 32 is a rigid member, 36 is a flexible tube, 44 is a tapered portion, 46 is a tear line, 48 is a vane, and 52 is an annular groove.

Claims (1)

[Scope of Claims] 1 Valve means in a flexible tube for medical use, comprising a tube-shaped member that is in close contact with the inner wall of the flexible tube and has a closed end at one end, and an outside of the closed end. an elongated rigid member integrally attached to the closed end and located within the flexible tube; and weakening means provided on the closed end for permitting opening of the closed end; comprises an annular thin-walled web integrally connecting the rigid member to the outside of the closed end, and the thin-walled web is formed by manually bending the rigid member near the closed end from outside the flexible tube. Valve means in a flexible tube, characterized in that the valve means is adapted to be pulled and ruptured. 2. The elongated rigid member is adapted to fit within the tubular member to enable resealing of the valve after being pulled away from the tubular member to open the closed end. Valve means of paragraph 1. 3. The end of the generally rigid member adjacent the weakening means is tapered to facilitate sealing engagement within the tubular member. Valve means. 4. Valve means according to any one of claims 1 to 3, wherein said annular thin-walled web is provided with a frangible annular groove provided at said closed end of the tube-like member. 5. Valve means according to any one of claims 1 to 4, wherein said elongated generally rigid member is provided with longitudinal vanes to define a flow path along its length. 6. The valve means according to any one of claims 1 to 5, wherein the flexible tube is a flexible tube for connecting a plurality of blood bags. 7. Valve means according to any one of claims 1 to 6, wherein the tube-shaped member is mounted within the sealed edge of the blood bag with the closed end of the tube-shaped member facing outward. 8. The valve means of claim 4, wherein said annular groove is formed on a side of said closed end opposite said elongate rigid member. 9. The blades on the rigid member are of unequal length, with a pair of opposing blades extending rearwardly from a central end of the rigid member, and the flexible tube includes: when the weakening means is ruptured and the rigid member is separated from the tubular member, such that the rigid member moves to interfere with the tubular member to prevent accidental re-closing of the valve means; 6. Valve means according to claim 5, wherein the valve means is formed with a hole portion positioned to receive and resiliently retain the opposed vanes. 10. The valve means of claim 9, wherein said hole portion is conical. 11. The valve means according to any one of claims 2 to 10, wherein a projection means is provided on the rigid member to limit the insertion range of the rigid member into the tube-shaped member.