CA1333704C - Aseptic spike to luer fluid flow adapter - Google Patents

Aseptic spike to luer fluid flow adapter

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Publication number
CA1333704C
CA1333704C CA 552165 CA552165A CA1333704C CA 1333704 C CA1333704 C CA 1333704C CA 552165 CA552165 CA 552165 CA 552165 A CA552165 A CA 552165A CA 1333704 C CA1333704 C CA 1333704C
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CA
Canada
Prior art keywords
containers
container
spike
luer
fitting
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA 552165
Other languages
French (fr)
Inventor
Susan F. Barquist
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Corp
Original Assignee
Miles Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Miles Inc filed Critical Miles Inc
Application granted granted Critical
Publication of CA1333704C publication Critical patent/CA1333704C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Abstract

Device for establishing and maintaining an aseptic fluid flow path between a first container having a luer-type access port and a second container having a spike member.
The device comprises an elongate and generally tubular conduit having two dissimilar end portions. The first end terminates as a luer-type fitting complementary to a luer-type access port of the first container. The second end portion terminates as a spike-receiving fitting adapted to engage a complementary spike connected to the second container. In preferred embodiments, the device includes a transverse membrane within the second end portion. The membrane is adapted to maintain sterility and to be pierced by and assist in retaining the spike member of the second container.

Description

, 133370~ ' SPECIFICATION
Background of the Invention Field: This disclosure is concerned generally with fluid 5 flow connectors and specifically with a fluid flow adaptor having dissimilar end connectors that provide means for establishing and maintaining an aseptic fluid flow path between containers having dissimilar access means.

10 Prior Art: Devices for establishing aseptic fluid flow paths have been available for many years, especially for medical applications. Typical devices include intravenous lI.V.) fluid ~m~nistration sets and blood A~m;nistration or collection sets. See, for example, U.S. Patent No.
15 3,092,106 to Butler and U.S. Patent No. 2,999,499 to Willet. Such devices commonly consist of flexible plastic tubings (e.g., medical grade polyvinyl chloride or PVC) having end portions adapted for a particular function. In the case of I.V. or blood administration sets, the devices 20 typically include at one end a needle or cannula adapted for insertion into an injection site connected to another container or, a vein. The other end commonly includes a spike-like portion adapted for insertion into an I.V. fluid or blood container. All such medical devices should be 25 internally sterile and typically include removeable end protectors for maintaining such sterility.

Other medical devices which permit aseptic fluid flow are multiple blood bag systems which consist of two or more 30 plastic bags already connected via plastic tubing. Typical examples of such systems are shown in U.S. 4,609,372 to Carmen et al, U.S. 4,596,657 to Wisdom and U.S. 4,222,379 to Smith. In such multiple blood bag systems, the flow of a given fluid (e.g. blood or a blood component) from one 35 bag to another is controlled by various valve systems ~e.g.
clamps, rupturable membranes, frangible plastics, etc.) well known to those skilled in the art. See, for e~ample, 13~37~

U.S. Patent No. 4,586,928 to Barnes et al. These valves are externally manipulated and, accordingly, they permit fluid flow within a ~closed" system, an obvious ~afety feature. Although such closed systems are clearly 5 preferred to minimize risks of contAm;n~tion, it is not always possible to use or practical to fabricate such closed systems. This has resulted in various aseptic connectors such as those shown in U.S. 3,945,380 ~plasmapheresis assembly). Since the use of such o connectors involves entering a previously "closed" system, the systems are then considered "open~, even though the entry is made under substantially aseptic conditions.

More recently, so-called sterile-docking devices have been 5 devised to connect conduit tubings connected to two or more containers in a manner said to be sterile. See for example, U.S. 4,507,119 (showing a system which connects tubings from two plastic bags by a sterile heat weld of the tubings) and U.S. 4,157,723 (disclosing dedicated or 20 specially made tubing ends made from materials which open and then fuse to form a closed conduit when exposed to radiant energy).

Although the above systems for assuring transfer of fluids 25 in both open, closed and sterile docking systems are useful in specific applications, there are very few prior art devices that permit a relatively simple aseptic fluid transfer from containers having dissimilar container access means. This is especially true in the case of containers 30 which have a luer-like access means (male or female luer fittings) and containers which have a spike-like access means. See, for general examples of medical fluid flow adapters, the recent U.S. Patent 4,6D7,868 to Harvey et al (showing use of a threaded luer fitting). See also U.S.
35 4,336,802 to Stone et al (showing a solution mixing adapter) and U.S. 4,326,518 to Williams (showing a frangible in-line adapter).

1~33704 The need for a simple adapter for aseptically transferring fluids between containers is well known in plasmapheresis applications. In those cases, it is impractical or difficult to have a truely closed system for processing and 5 then transferring blood components from one container to another. To accomplish such transfers it has been common to employ collection, processing and transfer devices which are compatible in assuring a reasonably safe (although open system) fluid transfer under aseptic conditions. This has 10 limited the user's choice of devices which might be better or less expensive, though not compatible due to lack of a means for connecting dissimilar bag access ports. It also results in th~ need to carry larger inventories due to the lack of flexibility in choices available to the users.
15 Hence, there is a need for a practical adapter for such open systems. I have found that such a versatile adapter can be made. Details are described below.

SUM~ARY OF THE INVENTION
The connecting device or adaptor of this invention is an internally sterile and elongate tubular member having dissimilar ends. One end comprises a luer-type fitting adapted to engage a complementary luer-like fitting of a 25 first container. The other end comprises a spike-receiving member. The spike-receiving member preferably includes an inner, transverse, pierceable membrane adapted to assure sterility within the adaptor prior to and during engagement of the adapter. The membrane also acts to retain a spike 30 in communication with a second container by means of a friction fit. To assure an aseptic fluid flow between the containers, the interior fluid pathway of the connector is sterilized by known means and the respective end portions are covered by removeable end protectors. The protectors 35 are removed just before use, at which time the exposed end portions are available for aseptic engagement of complemen-tary fittings that communicate with the containers.

13~370~

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is a plan view of the preferred adaptor of this invention connecting two blood bags (the bags are not drawn 5 to scale) having dissimilar fluid flow access means.

Figure 2 is an enlarged elevation view of the disconnected adaptor shown in Figure 1.

Figure 3 is an enlarged, cross sectional view of the adaptor, taken along lines 3-3 of Figure 2.

Figure 4 is a plan view of the adapter of Figure 3, drawn to include end protectors.

Figure 5 is a perspective view of the adaptor of Figure 4 with the end protectors shown removed.

SPECIFIC EMBODIMENTS

The parts for the adaptor of this invention may be made from any medical grade materials such as PVC, ABS, silicone, and the like. In practice, a simple PVC tubing may be used as the flexible, central portion of the adapter. To each end of the tubing, there are sealed the relatively hard dissimilar plastic connectors. The sealing may be by methods known to those skilled in the art (e.g.
solvent welding using cyclohexanone, acetone, methyethyl ketone, etc.). The connector at one end is a luer-like fitting, adapted to engage via luer fit a complementary luer-like fitting in a first container. For example, if the luer-like fitting of the adapter is a male luer (as in a preferred adapter described below), the complementary luer-like fitting in the first container (or at the end of a tubing connected to the first container) will be a female luer. The connector at the other end of the adapter is a relatively rigid port adapted to receive and retain a spike ~ 1333704 which, in turn, is in or capable of fluid communication with the second container. Preferably, this end of the adapter also includes an internal, rupturable membrane located about ~ inch into the port and through which the 5 pointed spike is pushed and retained via friction fit.

As used herein, the term luer or luer-like refers to a connector which is tapered and mates with other tapered fittings in a liquid leak-proof and mechanically secure 0 manner. (See ANSI/HI~ 70.1 - 1983, a publication of the American National Standards Institute, Inc. 1430 Broadway, NY, NY 10018). In general, a luer or luer-like fitting has : a 6% taper (or 0.060 inch per inch on diameter). A
preferred luer fitting forms a taper of about 6% or .060 5 inch per inch on the diameter of the luer base.

A spike or spike like fitting means a pointed, hollow device which is used to pierce a membrane and/or fit inside a tube or other receptacle and allow fluid to pass in a 20 leak-proof manner through the hollow interior under aseptic conditions.

Aseptic, as used herein, means a procedure or device the use of which permits no compromise of sterility other than 25 a brief contact with ambient air. Sometimes referred to as "sterile technique", an aseptic technique for a medical procedure is well known to those skilled in the art of medical procedures.

30 The invention can be understood better by reference to the Figures.

Figure 1 shows an adaptor of this invention in place connecting two plastic blood bags. The adaptor, shown 35 generally as 12, is shown providing a fluid flow connection between a first blood bag (on left) having a communicating tubing 14 ending in a luer like fitting 16 engaging a 1~33~4 complementary luer like fitting 18 forming one end of adapter 12. At the other end of adaptor 12 i5 a spike-receiving member 20 shown generally in Figures 1, 2 and 5 and in cross section in Figure 3. Spike receiving 5 member 20 is transparent and shown engaging spike 22 which is connected to PVC tubing 24 which, in turn communicates with the second blood bag (on right). Though not visible in Figure 1, spike 22 is held in place via a friction fit with the inner walls 26 (of Figure 3) after rupture of 10 mem~rane 28 by spike 22. Once made, this combined friction fit, like a luer like fitting, is difficult to disengage.
It is thought that this combination of dissimilar yet difficult to disengage fittings in a single adapter is quite unique in a medical device, especially useful for a 15 device where inadvertent disengagement must be avoided.

~igure 2 shows the adaptor of Figure 1 without the dissimilar fittings 16 and 20 of the bags engaging the adaptor.

Figure 3 shows a cross sectional view of the adaptor, taken at lines 3-3 of Figure 2. This view shows that the preferred adaptor 12 consists of three parts (which may be solvent welded together).

On the left of Figure 3 is the male luer-like fitting 18 shown solvent welded to intermediate flexible tubing 19.
At the right of Figure 3, spike receiving member 20 is shown solvent welded to the opposite end of flexible tubing 30 1 9 . Luer fitting 18 should be relatively rigid and can be made from medical grade, preferably transparent, plastic materials such as medical grade polycarbonate. Inter-mediate tubing 19 is preferably made from a medical grade, flexible, transparent PVC material. Spike receiving member 35 20 is also made from a medical grade PVC but is preferably thicker and more rigid than tubing 19. Member 20 is also transparent and includes a pierceable and relatively thin -13~3704 transverse membrane 28 positioned about ~ inch into the bore and inner walls 26, both of which assist in the friction fit engagement of spike 22 and in maintA;ing sterility prior to and during container-to-container 5 connections (see below).

Figure 4 shows a plan view of the adaptor with sterility protecting caps 32 and 34 in place over the dissimilar ends of the adaptor.

Figure 5 shows the adaptor with protective caps removed.
Protective cap 34 is a frangible cap which, when pulled by member 38, severs at a scored portion 36 leaving a portion (30 on Figure 3) still attached to the adaptor.

The cap for the male luer end of the adapter is made from a plastic such as polyethylene and held in place on the luer by simple friction fit, removable by simply twisting and pulling. The protector at the spike-receiving port can be 20 of any removeable type known in the art. The protector shown in Figure 5 is a frangible PVC material having a scored portion 36 adapted to rupture when top 38 is pulled away from the connector. This exposes inner transverse membrane 28 for penetration by spike 22.

In preferred embodiments, the adapter is relatively short, about 2 inches in length and flexible at the middle to allow easy engagements in the containers (preferably plastic bags) to be connected.

Although the adapter disclosed herein may be used to connect a plasmapheresis bag with a plasma bag or bottle, it can be used in any other application where a container with a luer-like fitting is to be put in fluid 35 communication with a spike-receiving connector (e.g. to connect non-complementary I.V. sets).

It should be noted that the disclosed adaptors can also be used, for example, with a blood cell separator machine.

The presence of the transverse membrane is preferred, 5 especially when the adaptor is used with flexible bags.
When a flexible system is opened, air can be drawn in or liquid forced out depending on the position of the unit.
This results in contaminated units or liquid around the connection or spillage all of which are inconsistant with 0 aseptic technique. If present the membrane thus protects the sterility of the bag until the spike connection is made.

Given the above disclosure, it is thought that variations 15 will occur to those skilled in the art. Accordingly, it is intended that the above example should be considered illustrative and that the invention disclosed herein should be limited only by the following claims.

:.

Claims (23)

1. A device for establishing and maintaining an aseptic fluid flow between a first container having a luer-type container access member and a second container having a spike member, the device comprising an elongate generally tubular body having a sterile interior and two end portions, a first end terminating in a luer fitting complementary to and for engaging via a friction fit the luer access member of the first container under substantially aseptic conditions and a second end portion terminating in a spike-receiving member for aseptically engaging, via a friction fit, a complementary spike member connected to the second container.
2. The device of claim 1 wherein the elongate tubular body includes an inner transverse membrane located toward the end of the second end portion, the membrane capable of being pierced by and assisting in the retention of the spike of the second container by a friction fit.
3. The device of claim 1 or 2 wherein the end portions include removable protective caps adapted to maintain sterility in the interior of the device.
4. The device of claim 1 or 2 wherein the end portions are relatively rigid compared to the remainder of the device.
5. In a device for providing aseptic fluid flow between two containers having dissimilar access means, the device comprising an elongate body for connection under aseptic conditions to each of the containers, the improvement comprising having dissimilar container-adaptor end portions at opposite ends of an elongate member, one of which is a spike-receiving member and the other of which is a luer-type fitting, thereby providing means for providing aseptic fluid flow between containers having dissimilar access means.
6. The device of claim 5 wherein one of the end portions comprises a male luer-type fitting.
7. The device of claim 6 wherein the fitting is a luer-type fitting having sides tapering at 6% when measured on the diameter of the luer bore, thereby assuring a secure friction fit when the fitting engages the access means of the first container.
8. The device of claim 5 wherein the spike-receiving fitting is connected to the luer-like fitting by means of an intermediate flexible tubing.
9. The device of claim 8 wherein the adaptor includes a pierceable interior transverse membrane for assisting in retaining a spike via friction fit.
10. The device of claim 5 wherein at least one of the containers is a plastic bag.
11. A multiple container system comprising at least two containers, the containers being in fluid communication with each other via an elongate adapter having two dissimilar container-adapter end portions, the end portions including a spike-receiving member and a luer-type member.
12. The system of claim 11 wherein the dissimilar container-adapter end portions comprise a male luer-type fitting and a spike-receiving type fitting, the fittings being connected by a relatively flexible tubing.
13. The system of claim 12 wherein the containers are plastic bags.
14. The system of claim 12, wherein one of the containers is a glass bottle.
15. The system of claim 12, wherein the tubing length is greater than the minimum legnth needed to receive and retain the spike.
16. The system of claim 11, wherein the tubing is part of a cell collection machine.
17. A device according to claim 1 or 2, wherein said first and second containers are flexible containers.
18. A device according to claim 3, wherein said first and second containers are flexible containers.
19. A device according to claim 4, wherein said first and second containers are flexible containers.
20. A device according to claim 5, 6, 7, 8, 9 or 10, wherein said two containers are flexible containers.
21. The system of claim 11, 12, 13, 15 or 16, wherein said at least two containers are flexible containers.
22. The system of claim 14, wherein another of said containers if a flexible container.
23. A system comprising first and second containers, said first container having a luer-type container access member and said second container having a spike member, and a device for establishing and maintaining an aseptic fluid flow between said first and second containers, said device being as defined in claim 1 or 2.
CA 552165 1986-11-18 1987-11-18 Aseptic spike to luer fluid flow adapter Expired - Fee Related CA1333704C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US93181686A 1986-11-18 1986-11-18
US931,816 1986-11-18

Publications (1)

Publication Number Publication Date
CA1333704C true CA1333704C (en) 1994-12-27

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA 552165 Expired - Fee Related CA1333704C (en) 1986-11-18 1987-11-18 Aseptic spike to luer fluid flow adapter

Country Status (1)

Country Link
CA (1) CA1333704C (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7942861B2 (en) 2002-10-22 2011-05-17 Baxter International Inc. Fluid container with access port and safety cap

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7942861B2 (en) 2002-10-22 2011-05-17 Baxter International Inc. Fluid container with access port and safety cap

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