Patent Grant
8827978
This application is a National Stage application under 35 U.S.C. §371 and claims the benefit under 35 U.S.C. §119(a) of International Application No. PCT/SE2007/050657, having an International Filing Date of Sep. 17, 2007, which is incorporated herein in its entirety.
The present invention relates to an attachable membrane for injection of fluid into a pierceable fluid container, or the withdrawal of fluid therefrom.
Within several applications it is required to transfer pharmaceuticals or medicaments into a fluid container such as an infusion bag. Usually such infusion bags are filled with a transport liquid such as saline solution or glucose solution in order to simplify the drug preparation of such an infusion bag. Infusion bags are generally equipped with an injection port to provide medicaments and a piercing port to extract the fluid from the infusion bag to an infusion system and thereafter usually to a patient. These pre-manufactured ports on the infusion bags make them less flexible for use together with other injection devices. Manufacturing fluid containers having predetermined injection and extraction ports is also complicated in the sense that it adds manufacturing steps to the manufacturing of the fluid container itself.
One way of partly overcoming these drawbacks is described in the publication of WO 94/13247. The document describes a valve device comprising a valve body with a barrier membrane and a surrounding portion. The valve device has an adhesive surface located at the underside of the valve body to attach the valve body to the surface of an infusion bag. The valve device is manufactured in one piece of the same material and its main purpose is to be applied and handled on the occasion of use while retaining aseptic conditions even by persons of impaired sight. However even for persons with good sight the described solution may have drawbacks. Although allowing for any piercing member to be inserted through the membrane the document is completely silent about the drawback that the inserted piercing member may tear, rip, or even puncture the fluid container unless the user is cautious when handling the piercing member.
The publication of WO 82/03776 describes one way of trying to solve a related problem. The publication discloses a device for providing a barrier membrane to the surface of a flexible fluid container. The barrier membrane is adhered to the surface by an adhesive. Additionally the barrier membrane may be arranged with a flexible tube attached to a cylindrical casing. At the other end of the tube, the tube may be tightly connected to a holder for a hollow syringe needle. The syringe needle is surrounded by the tube which is slideable arranged to the syringe needle and is further provided with an arresting shoulder. The arresting shoulder of the syringe needle is in turn connected to connection means of a conventional type for a liquid conduit. The length of the tube is adapted such that its rear end rests against the holder of the syringe needle. When the needle is inserted the tube will also be inserted into the fluid container for as far as the arresting shoulder allows. The described solution provides for a rather complicated mechanism having moving parts for introducing or withdrawing a liquid into a flexible fluid container. There is a need for simpler solutions which maintain or even improve the safety of the process.
It is an object of the present invention to at least partly provide a solution to the above mentioned problems. It is further an object of the present invention to provide a simple attachable barrier membrane device which allows the user to safely introduce or withdraw liquid from a pierceable fluid container. The present objectives are achieved by an attachable membrane device for providing a pierceable liquid barrier membrane at the surface of a pierceable fluid container, such as an infusion bag, i.e. immediately adjacent to the surface of the pierceable fluid container or in the vicinity of said surface. The attachable membrane device have a fastening part comprising a fastening surface adapted to be attached to the surface of the pierceable fluid container and thereby provide a liquid tight seal between the fastening surface and the surface of the pierceable fluid container. The attachable membrane device is further provided with a barrier membrane part adapted to provide a liquid tight seal after penetration by a piercing member. The attachable membrane device is further arranged with connection means to connect and lock a piercing member device to the attachable membrane device from movement in a direction substantially longitudinal with the piercing member. The solution provides for a simple and direct connection to the barrier membrane onto which an injector or similar may be attached. The connection means also allows for a user to actually let go of a piercing member device after assembly with the attachable membrane device, allowing the user to perform other tasks e.g. nursing. Additionally, the connection means provides a grip for the user, which may be utilized when attaching the attachable membrane device to the fluid container.
The barrier membrane part and the fastening part may be separate parts arranged to be attached to each other. This embodiment is particularly advantageous when the fastening part needs specific properties or when the barrier membrane needs to have more pronounced sealing properties. The barrier membrane part and the fastening part may be integrally formed from one material. Such an embodiment may be advantageous from a manufacturing perspective since it allows for the manufacturing of the fastening part and the barrier membrane part in one step by e.g. moulding. The material used in this embodiment is chosen so as to provide for sufficient sealing properties while still impart sufficient strength to the fastening part. Preferably such embodiments are made from thermoplastic elastomers.
In one embodiment of the present invention the fastening surface is arranged with an adhesive to fasten the fastening part to the pierceable fluid container and thereby also provide for the liquid tight seal between the fastening surface and the pierceable fluid container. Although adhesive may be applied separate to the surface of the pierceable fluid container in order to attach the attachable membrane it is preferred that the fastening surface is provided with a binder such as an adhesive. Additionally such thin layer of adhesive may be provided with a protective layer preferably a silicone based release layer which is easy to peel off before attaching the barrier membrane device to the surface of the pierceable fluid container.
In a preferred embodiment of the present invention the connection means comprises a neck element having at least one guiding means, preferably two or more, to guide a piercing member device to a locked position. Preferably the neck element comprises two guiding means having the form of guiding grooves which during assembly with a piercing member device guide the piercing member device to a locked position. Usually such a piercing member device may be in the form of an injector. Once in the locked position the piercing member device is prevented from movement in a direction perpendicular to the fastening surface of the attachable membrane device.
In another embodiment of the present invention the fastening part of the attachable membrane device is arranged with a fluid channel extending from the fastening surface to the barrier membrane part. Such fluid channel has the main purpose of allowing a piercing member that is displaceable with respect to the locked piercing member device, such as a needle, to freely run through the fastening part without the need of penetrating any matter, except for the barrier membrane part, before piercing the fluid container. The embodiment simplifies the insertion of a piercing member while at the same time preventing the piercing member device from disengagement from the attachable membrane device.
In another embodiment of the present invention, the fastening part may comprise a compression volume. The compression volume may be arranged at the end of the fluid channel at the fastening surface of the fastening part. The compression volume is generally a substantially hollow space within the fastening part, or at least partly within the fastening part, which will allow the fastening part to be slightly more compressible. The fastening part may be provided with at least one compression volume, at least two compression volumes or at least three compression volumes. It may be arranged as above, in the proximity of the fastening surface but it may also be arranged at the proximity of the side edge of the fastening part or fully inside the fastening part. This enables a piercing function to the attachable membrane device without actually penetrating the fluid container by means of the piercing member device itself. Instead the actual piercing of the fluid container will take place after assembly with the piercing member device when the fastening part is compressed by a user. After compression the fastening part is preferably restored to its original shape and the piercing member is retracted back from the pierceable fluid container. Fluid may then be injected to the fluid container (or withdrawn). The compression volume will temporarily get filled with the fluid during this action. Leakage is effectively prevented by the liquid tight seal provided by the binding substance, e.g. an adhesive.
A piercing device may be attached to the connection means. Embodiments of the present invention having piercing devices are advantageous in combination with at least one compression volume. The piercing member of the piercing device is equipped with a piercing tip to pierce the pierceable fluid container. The piercing device may be either an integrated part of the connection means as illustrated in
In an additional embodiment of the present invention the connection means comprise a rigid material such as a rigid polymeric material. This allows for a sturdy connection with a piercing member device. In combination, or not, the fastening part may comprise a flexible material. By making the fastening part with a flexible material the risk of inducing damage to the fluid container is less as would otherwise be the case. Further will a force absorbing property be achieved. The fastening part may however comprise a rigid material such as a rigid polymeric material. This is especially advantageous when the connection means and the fastening part is constructed from the same material, i.e. when the fastening part and the connection means are integrally formed from one material. Preferably such an embodiment is formed by injection-moulding.
In one embodiment of the present invention a separate force absorbing material is arranged between the connection means and the fastening part. Such force absorbing material preferably comprises flexible material and is especially useful when the connection means and the fastening part are made of rigid material.
When a separate barrier membrane is used to create the barrier membrane properties, the separate barrier membrane is preferably attached in a slightly compressed state to the connection means. This can be done e.g. by means of the attachment method. The advantage of such an embodiment is that a piercing member of a relative large diameter can be used since the barrier membrane will flex back due to the compression. The barrier membrane is preferably compressed in the radial direction when welding the membrane to the connection means. The barrier membrane may as well be compressed in the direction in which the piercing member is intended to penetrate the barrier membrane, i.e. in a direction towards the centre of the pierceable fluid container.
With the term “piercing member” is meant a needle or a needle like object or a hollow tube like object which is intended to pierce another object such as a membrane or similar for the purpose of transferring a fluid (liquid, gas or combinations thereof).
With the term “piercing member device” is meant any device onto which a piercing member may be arranged, e.g. an injector or a syringe or the like.
The present invention will be described in greater detailed with referral to the following figures wherein;
Referring to
The fastening surface 103 may be equipped with a thin layer of a binder such as an adhesive 103a. In the shown embodiment of the present invention the fastening part 102 can be said to comprise at least a first and a second fastening part section 102a, 102b. The first fastening part section 102a is specifically arranged to adapt the membrane device 101 to be used with piercing members having a determined work length. By the term determined work length it is meant that the length of the piercing member correlates to the length of the first fastening part section 102a so that only a pre-determined length of the piercing member can be inserted into the pierceable fluid container. The second fastening part section 102b is specifically arranged to create a relatively large fastening surface 103.
In the illustrated embodiment of the present invention the first fastening part section 102a has a diameter da which is only approximately 20% of the diameter db of the second connection section 102b. The first fastening section 102a has further a concave form to explicitly form a force absorbing part 106 on the fastening part 102. The force absorbing part 106 is formed in that part of the first fastening section 102a with the smallest diameter. The force absorbing part 106 allows for the fastening part 102 to absorb some of the forces that it is subjected to it by means of the connected fluid container or a user. Such forces may occur during or after connection. The purpose is to absorb forces acting on the attachable membrane device from the pierceable fluid container to reduce the risk of the attachable membrane device detaching from the surface 104 of the pierceable fluid container.
It has also been found that it is advantageous to have a flexible outer rim 107 on the second fastening part section 102b. By having a flexible outer rim the fastening part 102 is effectively prevented, to a certain extent, from causing harm to the pierceable fluid container when e.g. bending forces are applied to the attachable membrane device. Such a flexible outer rim 107 is preferably made from the same material as the fastening part 102 itself, however, in such case the thickness of the rim is small enough to provide for an acceptable flexibility. As indicated above the flexible outer rim 107 can be made from a different material than the fastening part 102.
In
A fluid communication channel 109 arranged in the center of the fastening part 102 extends from the fastening surface 103 to the barrier membrane part 105. The fluid channel 109 is adapted to provide a channel for a piercing member which may be inserted through the channel to pierce the pierceable fluid container. Although a fluid channel is not a necessary feature of the present invention it is preferable since it will simplify the insertion of a piercing member since a piercing member only needs to penetrate the barrier member part 105 and not the whole of the fastening part in order to reach the surface 104 and thereafter the interior of the pierceable fluid container.
In some embodiments of the present invention the fluid channel does not need to extend the whole way from the barrier membrane to the fastening surface. It may well be that the fluid channel ends just above the fastening surface so that a second barrier membrane is created by means of the fastening part. Hence more generally, the attachable membrane device may be equipped with two barrier membranes in order to provide a secure liquid tight seal around the piercing member so as to prevent leakage of fluid. The fluid channel is in such an embodiment arranged between a first and a second barrier membrane.
As mentioned the attachable membrane device 101 comprises connection means 110 to connect and lock a piercing member device 550 to the attachable membrane device 101. Such piercing member device 550 may for instance be an injector assembly such as described in US 2003/0070726 A1 or e.g. as described in WO 2004/004806 (injection component 29). In any case the connection means 110 may comprise a cylindrical neck element 111 as described in greater detail in EP 1,434,549 A1 (in combination with a fluid container). The neck element 111 is in the current embodiment of the present invention equipped with two guiding members in which corresponding guiding means on the piercing member device may enter to connect and lock the piercing member device 550 to the connection means 110 and the attachable membrane device 101.
In the embodiment of the present invention shown in
In
The attachable membrane device 201 is shown having a fastening part 202 with a first fastening part section 202a and a second fastening part section 202b. The connection means 210 similar to the one described with respect to
The fastening part 202 may be formed from a flexible material such as a rubber-like material e.g. natural rubber, styrene rubber, urethane rubber or the like. Other suitable material may be thermoplastic elastomer (TPE) based on e.g. styrene, olefin, urethane, esters or amides. Any functional mixture of the above may also be suitable.
The connection means 210 is suitably formed to be rigid; preferably the connection means 210 is formed from a thermoplastic material such as polyethylene, polypropylene, polystyrene, polyurethane, polyvinyl chloride or the like. The connection means 210 may also be formed of a thermosetting plastic material such as epoxide esters (EP) or any other suitable thermosetting plastic material.
Further illustrated in
In another embodiment of the present invention at least one compression volume 220 is arranged at the end of said fluid channel at the fastening surface 203 of said fastening part 202. The main purpose of such compression volume 220 is to allow for the fastening part 202 to flex in the longitudinal direction of an attached piercing member. It is also possible that the compression volume is located elsewhere as long as it provides for the intended function of allowing the fastening part 202 to be compressed. The feature allows for a piercing member to pierce a pierceable fluid container by simply compressing the attachable membrane device after a piercing member device has been connected and locked onto the attachable membrane device. When using this embodiment of the present invention it is not necessary that such piercing member is maintained inside the pierceable fluid container, it is enough that the piercing member makes a hole in the surface 204. Any fluid which is inserted into the pierceable fluid container may be temporarily maintained inside the compression volume 220 due to the liquid tight seal effectively provided for between the fastening surface 203 and the surface 204 of the pierceable fluid container before it is forced into the fluid container e.g. by pump means used by the user. The barrier membrane 205 prevents any such liquid from escaping out from the fluid communication channel 209.
In the shown embodiment in
The piercing tip 314 preferably extends into the fluid channel 309 as illustrated in
Alternative, the connection means, to connect and lock a piercing member device from movement in a direction substantially longitudinal with the piercing member, may be in the form of a male connection part (not shown). However such male connection part must be equipped with a locking flange, preferably a circumferential locking flange, so that any connecting fluid container or coupling device can lock to said locking flange in order to prevent movement in a direction substantially longitudinal with the piercing member.
Further illustrated is a fastening part 402 having a first fastening part section 402a with a diameter da which is only approximately 20% of the diameter db of the second connection section 402b. The fastening part 402 has a concave form to form a force absorbing section on the fastening part 402. A thin layer of adhesive 403a is shown attached to a fastening surface 403.
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