The present invention relates to a seal and in particular to a seal useful in systems for the sterile transfer of fluids.
Validation and accountability are vital in most scientific industries and especially so in the pharmaceutical and biotechnological industries. A major challenge to these industries is the need to demonstrate accurately and reproducibly that sterility is achieved and maintained throughout production lines within a plant. This must be done in a manner which meets the stringent requirements of regulatory bodies such as the United States FDA. Acceptable standards can be difficult to be met when a substance is transferred from one sterile location to another sterile location by non direct means. Reliable and durable seal means must be employed during such transfer.
The present invention provides a seal for sealing between two members which are mutually movable so as to slide relative to each other, a first one of the members having formed on a surface thereof facing a second of the members at least one deformable plastics rib for contacting the second member and sealing between the two members when they are stationary or moving relative to one another.
Ideally, the first one of the two members is constructed of plastics material and the rib may be formed integrally therewith.
The rib is sufficiently deformable and flexible so that it drags or wipes along the surface of the second member with which it is in contact as the two members slide with respect to one another. A plurality of sealing ribs may be provided, axially spaced apart from one another along the path of relative movement between the members.
In a most preferred embodiment, one of the members comprises a body with a first channel formed therein, the channel having a longitudinal axis and the other member being receivable in the channel so that the two members slide relative to each other in a direction parallel to the longitudinal axis, a first one of the members having formed on a surface thereof facing a second of the members the at least one deformable plastics rib.
The rib itself may have different shapes and configurations, any of which will be suitable provided that they are such as to provide an effective seal between the members. For example, the rib may be formed with its free, sealing edge shaped as a U, V, W, “truncated V”, “truncated W” or any other suitable cross-sectional shape.
Of particular benefit is the use of such a sealing arrangement in a valve where a piston slides within a housing so as to open or close an open end of the valve. In such a case, it is advantageous to form the rib about the radially outwardly facing surface of the piston with the rib extending radially outwardly therefrom to impinge upon the interior surface of the housing.
Furthermore, it is of particular benefit to provide at least two ribs according to the invention on the surface of the first member so that the distance between the ribs along the path of travel of the two members relative one another is greater than a predetermined distance of travel of the two members relative one another along the path. Such an arrangement allows one of the ribs to always remain within a predetermined area on the surface of the second member. Such an area may for example be a sterile area inside a valve for sterile transfer of fluids in which a piston travels along a housing in order to open or close the valve. The above described arrangement of the ribs allows one of the ribs to always remain within the sterile area so as to maintain sterility inside the valve. The above described arrangement of the ribs may be used with various valves for sterile transfer of fluid, such as for example, the valves described in WO 03/090842 and WO 05/012775.
The seal of the present invention may use as an alternative or addition a known sealing means, such as an O-ring seal.
Tolerances for transverse dimensions of the channel in the body, for the receivable member and for the at least one deformable plastics rib may be rather strict in order to enable the rib to seal between the two members. These tolerances therefore may be difficult or costly to meet. In view of this, it is advantageous to provide an adaptor between the wall of the channel and the receivable member, the adaptor comprising an endless skirt provided around a surface of one of the channel or the receivable member facing the other member, the skirt being connected to the member and being movable with the member so that mutually facing surfaces of the skirt and of the member to which the skirt is attached are spaced to define a gap therebetween, the at least one deformable plastics rib being formed around one of the mutually facing surfaces of the skirt and said other member, the skirt being sufficiently deformable and flexible in order to enable adjustment of the skirt to accommodate dimensional irregularities between the skirt and said other member when the two members are engaged so as to allow the at least one rib to seal between the mutually facing surfaces of the skirt and said other member when the two members are stationary or moving relative each other. The provision of such a deformable skirt permits less strict tolerances to be applied in the manufacture of the two members.
Preferably, the skirt comprises a free end portion and a base portion about which the skirt is connected to the member.
In a most preferred arrangement, the skirt is formed around the receivable member and the rib is formed around the external surface of the skirt so that in use the skirt deforms in the channel to adjust to dimensional irregularities between the external surface of the skirt and the wall of the channel to enable the rib to seal therebetween.
Ideally, the skirt is sufficiently resilient to regain its original state upon withdrawal of deformation.
Of particular benefit is the provision of the skirt about the outwardly facing surface of the piston in the above described valve with the rib being formed around the external surface of the skirt.
In a most preferred arrangement, the skirt is provided as an attachment connectable to the member via a coupling means. Preferably, the coupling means comprises a snap-fit arrangement between the skirt and the other member. Ideally, the snap-fit arrangement a series of alternating resiliently deformable ribs and grooves formed around each of the mutually facing surfaces of the skirt and the other member, the ribs of the skirt and the other member being deformable on assembly so as to engage with the corresponding grooves of the member and the skirt. In the arrangement where the skirt is provided as an attachment couplable with the receivable member, the skirt is provided open ended.
In one arrangement, the skirt may be formed integrally with the member, preferably, by forming an endless slot in the material of the member so that the slot is defined by mutually facing endless surfaces of the skirt and the member.
The preferred material for the manufacture of the skirt is plastics, but other suitable resiliently deformable materials may be used.
Ideally, the skirt is configured to be sufficiently resiliently deformable under a predetermined pressure range of fluid supplied into a gap between the mutually facing surfaces of the skirt and the member to which the skirt is attached, so as to deflect towards the other member thus enhancing the sealing action of the at least one rib between the skirt and the other member. This feature of the skirt is particularly useful in an application in a valve for sterile transfer of fluids. Typically, in such valves, fluid being transferred through the valve is supplied under a higher line pressure. It is advantageous therefore to locate the skirt on the piston of the valve with the opening of the gap facing against the direction of the fluid flow so that the part of the fluid that enters the valve also flows into the gap.
In one arrangement, instead of forming a plurality of ribs around the skirt or the other member it is possible to form a thickening on a length of the skirt or the other member parallel the longitudinal axis of the channel which would otherwise be occupied by a pair or more of spaced apart ribs.
It will be appreciated that the above described adaptor is not limited to the use only with the above described sealing ribs. Therefore, in another aspect, the invention provides an adaptor for connecting two members, one of the members comprising a body with a channel formed therein, the channel having a longitudinal axis and the other member being receivable in the channel so that the two members can slide relative to each other in a direction parallel to the longitudinal axis, the adaptor comprising an endless skirt provided around a surface of one of the channel or the receivable member facing the other member, the skirt being connected to the member and being movable with the member; wherein mutually facing surfaces of the skirt and the member to which the skirt is attached are spaced to define a gap therebetween; the skirt being sufficiently deformable and flexible in order to enable adjustment of the skirt to accommodate dimensional irregularities between the skirt and said other member when the two members are engaged thus permitting less strict tolerances to be applied in the manufacture of the two members. The adaptor may advantageously be provided with one or more sealing ribs as herein described.
The invention will now be described with reference to the accompanying drawings which show, by way of example only, several embodiments of the seal according to the invention
In the drawings:—
a is an enlarged view of area S of
a is an enlarged view of area P of
Referring to
In use, when the cylinder 1 is loaded into the channel 2, the most peripheral region 9 of the surface of the rib 4, 5, 6, 7, 8 abuts the wall of the channel 2 and deforms in order to permit the cylinder 1 to enter the channel 2. The abutment is sufficiently close and tight that a seal is formed between the wall 10 and the rib 4, 5, 6, 7, 8. This seal remains intact during subsequent movements of the cylinder 1 along the channel as the deformable rib 4, 5, 6, 7, 8 drags or “wipes” along the wall of the channel 2.
It will be appreciated, that the seal of the invention is not limited to sealing between members which slide relative to one another about a common concentric axis. Rather, the seal of the invention can be used to seal between any two surfaces which slide relative to each other. The sealing rib will be provided substantially perpendicular to the axis which is substantially parallel to that in which the surfaces of the members slide relatively to each other.
Typically the tolerances for the outside diameter of a cylinder 1 and the inside diameter of a channel 2 of body 3 are rather strict and therefore are difficult or costly to meet in order to enable sufficiently close and tight abutment of the deformable ribs with the wall of the channel to be achieved.
It is preferred for the skirt 22 to be sufficiently resiliently deformable to counteract excessive deformation when inserted into the channel 3 and to regain its original shape upon withdrawal of the deformation. In effect, in such an arrangement the skirt 22 acts as a resilient adaptor between the channel 3 and the cylinder 20 and permits less strict tolerances to be applied to the diameter of the channel and the outside diameter of the skirt 22 thus reducing production costs.
In
Although the skirts 22 and 52 are shown having the ribs 30 and 34, respectively, the skirts are equally suitable for any of the ribs 4, 5, 6, 7 and 8, or any combination of them, as well as for other shapes in accordance with the invention.
In an application to valves for sterile transfer of fluids, the skirt 22, 52 is adapted to match particular sizes and shapes of the piston and the housing of a valve. For example, as shown in
As shown in
Another useful feature and function of the skirt 52 in a valve for sterile transfer of fluids will now be described with reference to
The ribs 4, 5, 6, 7, 8, 30, 34 have been described as formed around a cylinder 1 but of course such ribs 4, 5, 6, 7, 8, 30, 34 may be provided around the wall defining the channel 2 of the body 3 in order to form a seal with the external surface 1a of a cylinder 1 received in the channel 2. Similarly, the skirt may be formed around the wall in the channel so that the seal is formed between the inner surface of the skirt and the external surface of the body. Furthermore, the rib or ribs need not necessarily be formed around the skirt. For example the ribs may be formed around the channel whereas the skirt with no ribs thereon may be formed around the body receivable in the channel. Similarly, ribs may be provided around the body whereas the skirt may be provided around the wall in the channel.
Suitable materials other than plastics materials may be utilised in the manufacture of the skirt.
It will be appreciated that the neither the rib nor the skirt of the invention is limited to use only in a cylinder or in a circular channel and indeed can be provided around a body or around a wall of a channel of any cross-sectional shape, such as for example square or any other shape suitable to provide a seal.
Furthermore, it will be appreciated that the skirt 22, 52 of the invention is not limited to the use only in conjunction with the above described sealing ribs 4, 5, 6, 7, 8, 30, 34. The skirt 22, 52 can be used just for connecting two members without sealing therebetween. The two members can comprise for example a first body with a channel formed therein, and a second body receivable in the channel so that the two members can slide relative to each other. The skirt 22, 52 may be provided around the wall of the channel in the first body or around the exterior of second body so that on engagement of the two bodies the skirt will resiliently deform to accommodate dimensional irregularities between the skirt and one of the wall of the channel or the exterior of the second body. The provision of the skirt between the two bodies thus permits less strict tolerances to be applied in the manufacture of the two bodies.
It will of course be understood that the invention is not limited to the specific details as herein described, which are given by way of example only, and that various alterations and modifications may be made without departing from the scope of the invention as defined in the appended claims.
This application is a continuation application of U.S. patent application Ser. No. 11/658,799, filed Jul. 29, 2007; which is the National Stage of International Application No. PCT/US2005/027288, filed Jul. 29, 2005; which claims the benefit of U.S. Provisional Application No. 60/592,698, filed Jul. 30, 2004; the contents of which are incorporated by reference herein.
Number | Date | Country | |
---|---|---|---|
60592698 | Jul 2004 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 11658799 | Jan 2007 | US |
Child | 12836869 | US |