Sterilized, unitary container and fluid transfer set

95~;

--1- STERILIZED I UNITARY C~)NTAINER AND FLUID TRANSFER SET _ _ _ Field of the Invention ~rhe invention pertains to an apparatus for dispensing various types of medically related fluids as well as sterilization of same. More particularly, the invention pertains to a method of sterilizing a fluid-filled container and attached fluid transfer set simultaneously while permanently fusing the transfer set to the container.

Back round of the Invention The use of flexible containers filled with sterile fluids is generally known in the art.

Further, the manufacture and use of sterile transfer sets which can be coupled to the flexible containers, usually via a dispensing port, are also generally known in the art.

Such ~luid-i~1ed containers and related transfer set6 are routinely used for a variety of medically-related procedures. These include, dispensing of blood components, and dispensing and receiving peritoneal dialysis fluid. Further, the dispensing of various types of nutritional, parenteral and other medicinal solutions is well known.

The prior art transfer ~ets have often been formed of a medical grade vinyl plasti~. The solution filled containers are often sterilized using steam sterili~ation in an autoclave. How~ver, because of a tendency of the interior surfaces of the lumens of the transfer cets to soften and stick together, thereby blocking the fluid flow passages, such sets have not been routinely sterilized using heat. Rather, the transfer sets have very often been sterili~ed by means of radiation or gas.

It has also been generally known in the art to permanently couple the transfer sets to the fluid dispensing port of the container by means of a plastic softening solvent. The solvent bon~s a selec~ed connector or end of the lumen of t~e transfer 6et to the di~pensing port on the container. There are circumstances where it is undesira~le or not feasible to use ~olvent to bond these two mem~ers together. Ihis is particularly the case where it is desirable to make sure that no solvent or solvent residue can be transfered to the fluid in the containerr Thus, there continues to be a need for a method of coupling a transfer set to a fluid-filled container which does not utilize known solvents.

Further, there continues to be a need for ~terile transfer sets coupled to fluid-filled containers where the sterilization of the container, ~he fluid and the transfer set has been carried out in a single ~tep~ Summar of the Invention In accordance with ~he invention, a method is provided for attaching a fluid dispensing set to a fluid-filled container simultaneously while sterilizing the container, the set and the fluido A fluid-filled container is provided~ The container has a sealed, cylindrical fluid dispensing port. The fluid delivery set is sealed with the exception of a cylindrical spike ~onnector attached to one of the tubular members of the set.

The spike connector has a fluid flow pathway therethrough. The spike connector is thus in ~luid flow communication with the interior lumens of the transfer set.

~ 2~ The spike connector c~n be inserted into the dispensing port. A pointed end of the spike connector pierces the membrane seal in the port.

Part o~ the fluid in the container flows into the sealed set.

In a preferred embodiment, the spike connector is formed of rigid, vinyl plastic with a softening point on the order of the templeratures achievable in an autoclave. The container and set can then be placed in an autoclave and steriliæed.

In the process, ~he fluid is also sterilized. The part of the fluid that flowed into the lumens of the set assists in sterilization of the set. In addition, that portion of the fluid in the lumens of the set keeps the fluid flow pathways open and prevents the interior walls of the lumens from sticking together and blocking fluid flow through the set.

When the container and set are sterilized, the sterilizing heat melds the exterior peripheral surface of the spike connector to he interior surface of the port.

The connector and port fuse together.

On cooling, the vinyl connector and port harden into a single unit.

The method is advan~ageous in that the container, fluid and set can be manufactured in non-sterile conditions, assembled and then sterilized as an integral unit.

In addition, since the seal between the port and connector is formed as a result of sterilization heat, no solvent is used to create the seal. Hence, there will be no residual traces of solvent present to leach into the fluid in the container.

Finally, the present method is advantageous in that only one type sterilization i5 needed for the set, the fluid and the container.

A particular advantage of the present method is that it can be used in conjunction with any fluid that can be sterilized by means o* heat or autoclaving.

Thus, the fluids can include dialysis, parenteral, nutritional or medicinal solutions.

An aspect o this invention is as follows:

~ method of affixing a fluid delivery set to a container of fluid while simultaneously sterilizing the container, the set and the fluid comprising the steps of:

providing a first nonsterile subassembly comprising a fluid-filled container with a sealed, pierceable port, the interior of the port including a material which softens upon exposure to heat sufficient to sterilize the container and its fluid contents;

providing a second nonsterile subassembly comprising a fluid transfer set with a fluid flow conduit sealed at one end and having at another end a hollow spike connector affixed thersto for piercing the container port, the exterior of the spike connector including a material which is sealingly compatible with the interior material of the port and which softens upon exposure to heat sufficient to sterilize the fluid trans~er set;

creating a nonsterile assemblage of the first and second subassemblies by inserting the spike connector into the pierceable port to break the seal permitting fluid to flow from the container into the set toward the closed end thereof; and exposing the nonsterile assemblage to heat sufficient to sterilize the container, the fluid transfer set, and the fluid, thereby softening the interior of the port and the exterior of the spike connector to fuse the spike exteriox with the port interior, thereby bonding the transfer set to the container while simultaneously sterilizing the formerly nonsterile assemblage.

4a Numerous other advantages and features of the present invention will become readily apparent from the following detailed description of the invention and the embodiments thereof, from the claims and from the accompanying drawings in which the details of the invention are fully and completely disclosed as a part of this specification.

Brie~ DescriDtion of ~he Drawinqs FI&URE 1 is an overall planar, schematic view of a flexible, fluid-filled container coupled to a fluid transfer set, FIGURE 2A is a top plan view of a spike connector in accordance with the present invention;

FIGURE 2B is a side view, in section, taken along line 2B-2B of Figure 2A;

FIGURE 3 is a sectional view of the dispensing port of the fluid-filled container of Figure 1;

FIGURE 4 is a view, partly in section, illustrating the connector of Figure 2 and an attached fluid transfer set coupled to the dispensing port o~ the container of Figure 1; and FIGURES 5A through 5D illustrate schematically a method of assembling and sterilizing a container, fluid and a transfer set in accordance with the present invention.

D~tailed Description oE the Preferred Embodiment While this invention is susceptible of embodiment in many di~ferent forms, there is shown in the drawing and will be described herein in detail a 5~Çj specific embodiment thereof with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the specific e~bodiment illustrated. Figure 1 illustrates a fluid dispenslngassembly 10 in accordance with the present invention. The assembly 10 includes a lElexible plastic container 12 at least partly filled with a selected fluid F. The container 12 could be formed as is convention and well known in the art of any flexible, medical grade plastic~ The fluid F contained within the container 12 ca~ be any fluid which can be subjected to ~team sterilization in an autoclave. Neither the exact ~hape nor composition of the container 12 nor the precise fluid F contained therein is a limitation of the present invention.

The container 12 is formed, as îs well known in the art, with a dispensing port 140~ The port 14 is sealed with a pierceable membrane 16, illustrated in Figure 3, which retains the fluid ~ within the container 12.

The port 14 is cylindrical with an interior peripheral surface 18 adjacent the membrane 16.

The fluid dispensing port 14 can be affixed to the container 12 in a variety of ways.

For example, the port 14 can be sealed to the container 12 by means of radio frequPncy energy.

The exact configuration of the port 14 and its manner of being sealed to the container 12 are not a limitation of the present invention. PYeferably, the port 14 will be formed of a selected medical grade vinyl plastic.

Affixed to the container 12 and in fluid flow communication therewith is a fluid trans~er set 3~ 17. The exemplary fluid transfer set 17, shown in Figure 1, includes a first fluid flow conduit 20 coupled by a Y junction 22 to second and third fluid flow conduits 24 and 26. The conduits 20, 24 and 26 can be formed of conventional flexible medical grade plastic of a type that are well known in the ~rt.

Each o the conduits 24 and 26 has an encl 28 and 30.

Each of the ends 2B and 30 terminates in a dispensing port 28a and 30a. Each of the ports 28a and 30a i~ ealed by a pierceable membrane such as ~he membrane 16 in the port 14.

The conduit 20 has an end 38 with a spike connector 40 affixed thereto. m e spike connector 40l illustrated in Figures 2A and 2B, slidably engages the port 14 o~ the bag 12 piercing the membrane 16 at the same time. Once the membrane 16 ha6 been pierced, a portion of the fluid ~ in the container 12 can flow into the tubular members 20, 24 and 26 o the set 17. The me~brane s~als in the ports 28a and 30a prevent the portion of the fluid F therein from leaking from the set 17. As a result, the a~embly 10 of Figure 1 is a closed assembly which could be readily transported or delivered for subsequent useO Access to the fluid F could be obtainea using st~ndard spike connectors to pierce the membranes in the ports 28a ~nd 30a.

It wili be under~tood that the exact configuration of the fluid transfer set 17 is not a limitation of the present invention.

The connector 40, with respect to Figures 2A and 2B includes a cylindrical proximal end 42 on which is affixed the end 38 of the conduit 20.

Adjacent the proximal cylindrical end 42 is an integrally-formed cylindrical flange 44. ~he flange sf~ 44 has a planar surface 44a located distally of the proximal end 42.

A cylindrical ~apered member 46 is integrally~formed adjacent the surface 44a of the flange 44. The tapered member 46 terminates at a distal end 48 with a sharp point 50.

The point 50 is used for piercing the membrane 16 of the port 14. The spike connector 40 is hollow with an interior cylindrical peripheral wall 5~ which defines a fluid flow path through the connector 40.

The substantially cylindrical interior surface 18 of the port 14, a~ illustrated in Figure 3~ has an end diameter 18a that is slightly larger than an interior diameter 18b adjacent the membrane 16. The surface 18 thus defines a ~rusto-conical shaped space into which the tapered distal end 46 of the spike connector 40 can be inserted.

The connector 40 when inserted in~o the port 14, as illustrated in Figure 4, pierces the membrane 16. Part of the fluid F in the container 12 can then flow into the lumens of the tubular members 20, 24 and 26.

Subsequent to the connector 40 being inserted into the port 14, the assembly 10 can then be sterilized in an autoclave. The process of sterilization simultaneously bonds the connector 40 to the port 14.

The bonding or fllsing occurs where the connector 40 has been molded of a rigid vinyl plastic having a relatively low melding point. With such a connector, and assuming the port 14 is ormed of an appropriate vinyl material as wellp when the assembly 10 is heated to sterilization temperatures, the tapered surface of the distal portion 46 of th~ --8-connector 40 melds and fuses with the heat softened interior peripheral surface 18 of the port 14.

It is believed that plasticizers in the vinyl migrate when heated. This migration ~etween the connector 40 and port 14 forms a flllid tight bond.

The presence of a por~ion of the solution F in the lumens 20, 24 and 26 assists in the sterilization process. In addition, that fluid prevents the lumens of the conduits 20, 24 and 26 from sticking together and closing while being sterilized. ~he presence of the portion of the fluid F thus makes it possible to sterilize the set 16, which could be formed completely of vinyl plastic, by means of autoclaving simultaneously with sterilization of the container 1~ and the fluid F.

When the assembly 10 is removed from the autoclave, the connector 40 has become permanently bonded to the port 14.

The assembly 10 is then a single sterile unit which can be packaged for subsequent delivery.

The fused bond between the connector 40 and the port 14 eliminates any need to use a liquid solvent to bond the set to the container. ~ence, there is no solvent residue present which c n leach into the fluid F in the container ~2.

Prior to autoclaving, the container 12, ~he fluid F and the set 17 can be non-sterile. After autoclaving, the unitary assembly 10, including the fluid F, is sterile.

Figures 5A through SD schematically illustrate the present method. Figure 5A : schematically illustrates the ~ontainer 12 prior to assembly with the set 17. Prior to assembly with the set 17, the container 12 has been partially fiLled with fluid F. The set 17 is a s~aled set except for the connector 40 which is coupled ~o the condui~ 20.

~5~ Figure 5B illustrates the container 12 in fluid flow communication with the set 17.

Figure 5C illustrates the assembly 10 being placed in an autoclave A for steam sterilization.

Figure 5D illustratles the unitary assembly 10 af~er sterili~ation. In the assembly 10 of Figure 5D, the connector 40 is permanently bonded to the container 12.

From the foregoing, it will be observed that numerous variations and modiications may be effected without departing from the true spirit and scope of the novel concept of the invention. It is to be .understood that no limitation with respect to the specific apparatus illustrated herein is intended or should be inferred. It is, of course, intended to cover by the appended claims all such modif ications as fall within the scope of the claims.