HK1082437B - Prefilled and sealed medicament bag, port and method for establishing fluid connection between the bag and administration set - Google Patents

Description

Formed, filled, sealed solution container, port and method of establishing flow between the container and an administrative set

Technical Field

The present invention generally relates to a container, an access port and a method of establishing fluid flow between a container and an administration set. The access port is capable of establishing fluid flow from the container into a suitable administration set. More particularly, a valve or base is provided that is sealed to a container. A perforator or plunger in the valve punctures the container and provides access to the solution in the container.

Background

Containers for supplying medical liquids are well known. Typically, the container is made from a flexible film material which is folded and sealed together along the peripheral side edges thereof. Furthermore, the container typically has an inlet and an outlet. The container also typically has a means for piercing the outlet and establishing fluid communication between the means and the solution inside the container. At which time the solution may be expelled from the device and delivered to the administration set and/or patient.

It is extremely important to maintain the sterility of the medical fluid being delivered to the patient. However, contamination may occur when handling the medical fluid container. In an emergency situation, rapid manipulation of the various components of the container may result in the introduction of bacteria or other pathogens into the container, thereby increasing the risk of contamination of the container. For example, an operator may inadvertently contact and/or contaminate a sterile end surface of an input port or an output port. This contamination can then in turn lead to contamination of the contents of the container.

Moreover, the container for supplying the liquid medicine is generally flexible. It is therefore difficult to form a sterile connection with the flexible container and extract the substance therein in a sterile manner. For example, in U.S. patent No.29,656 to Chittenden et al, an additive delivery unit is disclosed having a tubular member sealed to a solution container. The unit has a needle for piercing the stopper of the solution container. It is difficult to use conventional medical connectors such as needles or piercing needles to obtain a liquid-tight and gas-tight connection through the flexible container.

Furthermore, the administration port is firmly bonded to the flexible container. However, the administration port of existing flexible solution containers is often the weakest part of the container. Thus, certain medical fluids that are sensitive to oxygen and/or other permeating gases may be compromised. Furthermore, preformed administration ports are formed as areas where leakage may occur and where ingress of contaminants may occur.

Other means for establishing fluid communication between the container and the administration set are also known. Generally, known access ports require two-handed operation and do not produce audible or visual signals when the access port is fully engaged. Moreover, many known access ports do not provide substantial protection against contact or air-borne contamination.

Accordingly, there is a need for a formed, filled, sealed solution container having an access port and a method for establishing flow between the container and an administrative set. Accordingly, there is a need for a medical fluid container having improved inlet and outlet ports to reduce the likelihood of contamination during storage and/or use. Moreover, there is a need for a medical fluid container and access port having improved ease of operation. Still further, there is a need for a solution container and access port having a liquid-tight seal to avoid leakage, reduce the level of contact and/or airborne contamination, and prevent the ingress of oxygen and/or other gases.

Disclosure of Invention

The present invention provides a formed, filled, sealed solution container having an access port and a method for establishing flow between the container and an administrative set. More specifically, the port is sealed to the container and has means for puncturing the container. Through which the liquid in the container is expelled from the container into the administration line. The administration catheter further delivers the liquid to an administration set.

The port may have a valve and a perforator. The valve has a peripheral sealing flange or ring that is capable of sealing to the container. The valve may form a cylindrical opening for receiving and slidably coupling with a perforator or plunger. The cylindrical opening is used to guide a perforator or plunger to puncture the container and provide access to the solution contained therein. The perforator or plunger has a hollow shaft with a tri-slope bevel at its end facing the container film. The tri-slope bevel of the perforator or plunger pierces and tears the tensioned film underneath the sealing flange of the valve.

The present invention can provide a one-handed operation and provide an audible and visual signal when the tri-slope bevel has punctured the membrane to allow the solution to flow out. Moreover, the present invention can completely close the flow forming path to avoid contact and airborne contaminants. The present invention also reduces the force required to pierce the film of the container. Also, the perforator or plunger of the present invention may not be removed from the liquid bonding site after the joint is made.

To this end, in one embodiment of the present invention, a container is provided. The container has a film, a port, and a sheet. The film is folded to define a side edge and the side edge is sealed to form a container interior space. The port has an outlet opening through which fluid communication with the interior space of the container is established. The tab is connected to the port and the tab can be positioned to establish fluid communication with the interior space of the container.

In another embodiment, the tab of the container is detached from the port after fluid communication is established.

In another embodiment, the container further has a perforator connected to the port, wherein the tab is connected to the perforator and further connected to the port and the tab is detached from the perforator after fluid communication is established.

In another embodiment, the container further has a housing, a first portion of the housing being connected to a second portion forming the sheet, wherein separation of the first portion from the second portion determines that fluid communication is established.

In another embodiment, the container further comprises a cock coupled to the port, wherein the tab is coupled to the cock and wherein the tab is removed from the cock before fluid communication is established.

In another embodiment, the sheet member determines that fluid communication is established and generates an audible signal.

In another embodiment, the container further comprises a conduit having a first end and a second end, wherein the first end is connected to the port.

Moreover, in another embodiment of the present invention, a port for establishing fluid flow from a container to an administration set is provided. The port includes a valve having a housing defining an interior space therein, a shoulder on the housing, a cock, a catch, and a plunger. The tap is connectable with the valve and is guided axially by a shoulder of the housing. The catch on the valve locks the tap and the tap sounds when locked. The plunger has a hollow shaft portion and a tip. The plunger is located inside the valve and the rotational movement of the tap forces the plunger to protrude from the interior of the valve to force its tip to pierce the container. When the tap is locked, the tip of the plunger is locked in the container.

In another embodiment, the port further has a gasket on the ram.

In another embodiment, the port further has a removable tab on the cock, wherein the tab blocks rotation of the cock.

In another embodiment, the port further has a knob connected to the plunger, wherein the knob guides the plunger within the valve and the knob also prevents rotation of the plunger.

In another embodiment, the port further has a peripheral base integrally formed with the valve, wherein the peripheral base is sealed to the container.

Moreover, in another embodiment of the present invention, a method for establishing fluid flow from a container to an administration set is provided. The method comprises the following steps: providing a port having a valve, a cock, and a plunger, wherein the valve has an interior for receiving the cock and the plunger; connecting a valve to the container; sealing the valve of the port to the container; rotating the plug such that the plug exerts a force on the plunger; piercing the container with a plunger; locking the cock and the plunger in a certain position; and generates an audible signal when the cock and plunger are locked in place.

In another embodiment, the method further comprises the step of providing a gasket, wherein the gasket maintains a seal between the plunger and the valve.

In another embodiment, the method further comprises the step of providing a tab on the tap.

In another embodiment, the method further comprises the step of removing the tab from the tap.

In another embodiment, the method further comprises the step of providing a conduit connectable to the tap.

In another embodiment, the method further comprises the step of inserting the plunger into the container.

In another embodiment, the method further comprises the step of locking the cock into the valve.

In another embodiment of the present invention, a port for establishing fluid flow from a container to an administration set is provided. The port includes: the perforator includes a valve having a shaft, a perforator having an arm and guided by the shaft of the valve in an axial direction, and a cantilever beam protruding from the valve and the housing. The cantilever beam prevents the perforator from disengaging from the valve. The housing has a first portion and a second portion connected. The shell engages the valve and forces the perforator to pierce the container, and after the perforator pierces the container, the first portion of the shell separates from the second portion of the shell.

In another embodiment, the port further has a gasket on the perforator, wherein the gasket provides a seal between the perforator and the valve.

In another embodiment, the port further has a finger pad on the first portion of the housing.

In another embodiment, the port further has a slot on the valve for receiving an arm of the perforator.

In another embodiment, the port further has a flange on the perforator for guiding the perforator in the shaft of the valve.

In another embodiment, the port further has a protrusion on the valve, wherein the protrusion mates with the housing.

In another embodiment, the port further has a tab on the housing, wherein the housing is operated by applying a force to the tab.

In another embodiment of the present invention, a method for establishing fluid flow from a container having a port to an administration set is provided. The method comprises the following steps: providing a valve, a perforator, and a shell, wherein the valve has an interior space and the perforator is located in the interior space of the valve, and the perforator protrudes from the valve; sealing the valve to the container; connecting the housing to the valve; forcing the perforator to pierce the container by rotating the shell; piercing the container bag with a perforator; locking the perforator in a position; and maintaining a seal between the perforator and the valve.

In another embodiment, the method further comprises the step of rotating the shell, wherein rotating the shell causes an axial stroke of the perforator.

In another embodiment, the method further comprises the step of embedding the perforator in the container.

In another embodiment, the method further comprises the step of locking the perforator in the valve.

In another embodiment of the present invention, a port for establishing fluid flow from a container to an administration set is provided. The port includes: a valve having a shaft, a perforator in the shaft of the valve, a beam on the perforator, and a latch on the valve. The valve is sealed to the container. The beam has a catch and the latch on the valve mates with the catch on the beam. The engagement of the latch with the catch locks the perforator.

In one embodiment, the engagement of the latch and the catch may produce a sound.

In one embodiment, the port also has a conduit connected to the shaft portion of the valve.

In one embodiment, the perforator is hollow.

In one embodiment, the port further has an arm on the beam for locking the perforator in the valve.

Furthermore, in one embodiment of the present invention, a method for establishing fluid flow between a container and an administration set is provided. The method comprises the following steps: providing a port having a gasket, a valve, and a perforator, wherein the valve has an interior space and the perforator is located in the interior space of the valve; sealing the valve of the port to the container; applying pressure to the perforator and forcing the perforator to pierce the container; locking the perforator and the valve in an activated position; and maintaining a seal between the perforator and the valve via a gasket.

In another embodiment, the method further comprises the step of breaking the seal between the valve and the container.

In another embodiment, the method further comprises the step of connecting the conduit to a valve.

In another embodiment, the method further comprises the step of locking the perforator in the valve to prevent rotation of the perforator.

In another embodiment of the present invention, a port for establishing fluid flow from a container to an administration set is provided. The port has: a valve having a shaft, a perforator in the shaft of the valve, a first tab and a second tab, a latch on the first tab, and a catch on the second tab. The valve seals to the container and the latch locks to the catch. The first and second fins are diametrically opposed and connected to the valve. Further, the first tab and the second tab are in contact with the perforator, wherein rotation of the first tab and the second tab forces the perforator to move toward the container.

In one embodiment, the latch and catch lock to produce an audible signal.

In one embodiment, the port further has a slot on the valve, wherein the slot has a lock for locking the perforator.

In another embodiment of the present invention, a method for establishing fluid flow between a container having a port and an administration set is provided. The method comprises the following steps: providing a valve having a shaft portion, wherein the valve is sealed to the container; providing a perforator in a shaft of the valve; rotation of the first and second tabs toward each other, wherein the first and second tabs are diametrically opposed and connected to the valve, and the first and second tabs are also in contact with the perforator; piercing the container with the perforator; locking the first and second flaps.

In another embodiment, the method further comprises the step of locking the perforator to the valve.

It is, therefore, an advantage of the present invention to provide a formed, filled, sealed solution container, port and method for establishing flow between the container and an administrative set that are capable of one-handed operation.

Another advantage of the present invention is to provide a formed, filled, sealed solution container, port and method for establishing flow between the container and an administrative set that generates an audible signal when the access port is fully engaged.

Another advantage of the present invention is to provide a formed, filled, sealed solution container, port and method for establishing flow between the container and an administrative set that generates a visual signal when the access port is fully engaged.

Still another advantage of the present invention is to provide a formed, filled, sealed solution container, port and method for establishing flow between the container and an administrative set wherein the access port is blocked from contact and the ingress of airborne contaminants.

It is yet another advantage of the present invention to provide a formed, filled, sealed solution container, port and method for establishing flow between the container and an administrative set wherein the access port provides a design having an activation mode and placement of the operator's fingers and/or hands is readily apparent.

It is yet another advantage of the present invention to provide a formed, filled, sealed solution container, port and method for establishing flow between the container and an administrative set wherein the access port reduces the force required to access the container.

Still another advantage of the present invention is to provide a formed, filled, sealed solution container, port and method for establishing flow between the container and an administrative set wherein the perforator may not be withdrawn from the container.

A further advantage of the present invention is to provide a formed, filled, sealed solution container, port and method for establishing flow between the container and an administrative set wherein the access port reduces the force required to penetrate the container.

Still another advantage of the present invention is to provide a formed, filled, sealed solution container, port and method for establishing flow between the container and an administrative set wherein the access port allows for the selection of different raw materials for the perforator and the valve.

Further features and advantages of the present invention, which will become apparent from the following detailed description of the presently preferred embodiments, are described in connection with the accompanying drawings.

Brief description of the drawings

FIG. 1 illustrates a perspective view of a container having an access port according to one embodiment of the present invention.

Figure 2A illustrates a perspective view of an access port in an embodiment of the present invention.

Figure 2B illustrates a perspective view of an access port in an embodiment of the present invention.

Figure 2C illustrates a perspective view of a valve of an access port in an embodiment of the present invention.

Figure 2D illustrates a perspective view of a cock of an access port in an embodiment of the present invention.

Figure 2E illustrates a perspective view of a plunger of an access port in an embodiment of the present invention.

Figure 3A illustrates a perspective view of an access port in an embodiment of the present invention.

Figure 3B illustrates a perspective view of a valve of an access port in an embodiment of the present invention.

Figure 3C illustrates a perspective view of a perforator and a valve of an access port in an embodiment of the present invention.

Figure 3D illustrates a perspective view of a perforator and a valve of an access port in an embodiment of the present invention.

Figure 3E illustrates a perspective view of a perforator of an access port in an embodiment of the present invention.

Figure 3F illustrates a perspective view of a housing of an access port in an embodiment of the present invention.

Figure 3G illustrates a perspective view of a housing of an access port in an embodiment of the present invention.

Figure 3H illustrates a perspective view of a housing of an access port in an embodiment of the present invention.

Figure 4A illustrates a perspective view of a perforator and a valve of an access port in an embodiment of the present invention.

Figure 4B illustrates a perspective view of an access port in an embodiment of the present invention.

Figure 4C illustrates a perspective view of an access port in an embodiment of the present invention.

Figure 5A illustrates a front view of an access port in an embodiment of the present invention.

Figure 5B illustrates a perspective view of a valve of an access port in an embodiment of the present invention.

Figure 5C illustrates a cross-sectional view of a perforator and an O-ring of an access port in an embodiment of the present invention.

Figure 5D illustrates a perspective view of an access port in an embodiment of the present invention.

Detailed Description

The present invention generally relates to a container having an access port and a method of establishing fluid flow between the container and an administration set. The port may be sealed to the container and may puncture the container to access the solution within the container. The solution can be drawn from the container into the interior of the port, wherein a conduit connecting the port to the administration set can further draw the solution into the administration set.

Referring now to the drawings, in which like numerals refer to like parts, FIG. 1 shows a container 100. The container 100 may be constructed by folding a film and sealing the film along the sides of the film. The folded film may then be filled with a medical fluid and sealed along its top to form a sealed fluid-filled container. The container 100 may be made of a transparent material such as Clearflex^TMAnd (4) preparing. The container 100 may contain a solution such as peritoneal dialysis solution. The container 100 may have an input port 120 for inputting additives into the container. The input port 120 may have an injection site protected by a plastic cap.

The container 100 may also have an output 130 for providing medical fluid to a patient. The output port 130 may have a liner of elastomeric material, such as a film 150, interposed between an end surface of the output port 130 and the access port 160. The membrane 150 of the output port 130 is engageable by the access port 160 to establish fluid communication between the access port 160 and the container 100. Furthermore, the administration line 140 connects the container 100 to an object, such as a patient, other bag, etc. A fluid path may be formed by connecting the administration line 140 to the container 100 and the target. The administration line 140 may be connected to the container 100 through an access port 160.

Referring now to FIG. 2A, the access port 200 is generally shown. To draw the solution from the container 100, the access port 200 may establish a fluid flow from the container 100 to the administration line 140 through the output port 130. In one embodiment of the present invention, the access port 200 has a valve 202, a cock 204, a plunger 206, and a gasket 208. The plunger 206 of the access port is shown in a standby position.

Referring to FIG. 2B, the plunger 206 of the access port 200 is in an activated position. The access port 200 may be activated by rotating the cock 204 from a substantially horizontal position (standby position) to a substantially vertical position. Rotating the cock 204 may depress the plunger 206 and/or puncture the container 100.

Referring to FIG. 2C, the valve 202 may be molded from a blend having a variety of different properties, such as having an elastic modulus of about 900MPa, for example. The valve 202 may be surrounded by a peripheral base 210, which base 210 may be ultrasonically welded to the membrane 150 of the solution container 100. The base 210 prevents the medical fluid from leaking out of the container 100. The valve 202 may provide a cylindrical housing 212 having two shoulders 214a and 214 b. The cock 204 may be axially guided by two shoulders 214a and 214b of the cylindrical housing 212. On the inside of the valve 202, an internal catch 209 is provided to establish the standby and activated positions of the plunger 206 as shown in fig. 2A and 2B, respectively. Preferably, a locking member may be provided to lock the plunger 206 in either the standby position or the activated position.

Referring again to FIG. 2A, the plunger 206 of the access port 200 is in a standby position, i.e., the cock 204 is in a substantially horizontal position, and the plunger 206 is enclosed within the valve 202. Referring to FIG. 2B, the access port 200 is shown with the plunger 206 locked in the activated position, i.e., the cock 204 is in a substantially vertical position, and the plunger 206 is protruding from the valve 202. Also, the valve 202 may have a latch that can lock the cock 204 in the activated mode. The locking of the cock 204 may be audible, thereby providing a signal that the cock 204 has been locked.

Referring to FIG. 2E, the plunger 206 may be molded from a blend, for example, having an elastic modulus greater than 1500 MPa. The ram 206 may provide at least three functions. First, the plunger 206 may puncture the membrane 150 of the container 100 and open a path for drawing the solution. The tip 216 of the plunger 206 may be designed to puncture and/or tear the film 150 located below the peripheral foot section 210 of the valve 202. More particularly, the plunger 206 may be shaped as a hollow cylinder that tapers from the first end 203 toward the second end 205 of the plunger 206. The outer surface 215 of the plunger 206 may have a first notch 217 and a second notch 219 positioned at an angle to each other at the second end 205 of the plunger 206 to form a tip 216. The second end 205 with the first and second notches 217 and 219 forms a tri-slope bevel 218 of the tip 216. Also, the design of the tip 216 of the plunger 206 as a tri-slope bevel 218 may produce minimal friction.

Second, the plunger 206 enables solution to flow from the container 100 into the valve 202 through the hollow shaft portion of the plunger 206. Third, the plunger 206 may have an axially outer beam 222 to guide the plunger 206 into the valve 202 during actuation of the access port 200. The axially outer beam 222 may have two lobes (knobs) 224a and 224 b. The axially outer beam 222 and the two lobes 224a and 224b can be used to guide the ram 206. The knobs 224a and 224b can prevent the plunger 206 from rotating. Also, the knobs 224a and 224b can position the plunger 206 in the standby position and the activated position. Preferably, a locking member is also provided to lock the plunger 206 in the standby or activated position.

Referring to FIG. 2D, the cock 204 may be molded from a blend, for example, having a modulus of elasticity of about 1000 MPa. The cock 204 provides a drain function for the valve 202 to allow liquid to drain from within the valve 202. A tear-off safety tab 211 is provided on the rotational path 223 of the cock 204 for blocking any inadvertent movement of the cock 204 to prevent inadvertent actuation of the access port 200. The safety tab 211 can block rotation of the cock 204 to lock the plunger 206 of the access port 200 in a standby position. The rupture disc 211 may be made of the same material as the cock 204. The rupture disc 211 is removably connected to the cock 204. The cut-out 213 between the rotational path 223 of the cock 204 and the disc 211 enables the disc 211 to be removed from the cock 204. Of course, the rupture disc 211 may also be removably connected to the cock 204 by other means, such as adhesive, etc.

The cock 204 can provide four functions. First, the cock 204 may establish a fluid path by connecting the administration line 140 to the container 100 as shown in FIG. 1. The cock 204 is hollow and has a press-fit shaft portion 225 at one end thereof for engagement with the administration line 140. Second, by providing the lever 226, the cock 204 may generate the force required to pierce the film 150 of the container 100. The operator's hand or fingers may be placed on the lever 226. Third, the cock 204 may act as a cam. For example, as shown in FIG. 2B, the cock 204 may activate the plunger 206 by rotating the lever 226 from a substantially horizontal position to a substantially vertical position. Fourth, the cock 204 may have a washer groove 228 and a snap catch 230. The gasket 208 has an annular shape. The gasket 208 may ensure the liquid-tight properties of the assembly and may prevent contaminants from entering the sterile fluid path. The snap catch 230 enables assembly of the cock 204 into the valve 202 without affecting the relative degree of rotation of the cock 204.

The access port 200 is assembled after the valve 202, plunger 206, gasket 208, and cock 204 are coupled. Removing the safety disc 211 and rotating the cock 204 approximately 90 degrees may cause an axial stroke of the plunger 206. When the plunger 206 is actuated or fully extended, the plunger 206 may be embedded within the body of the valve 202. After the plunger 206 is inserted into the body of the valve 202, the plunger 206 is not removed from the container 100. Also, the cock 204 may be locked into the body of the valve 202 to prevent rotation of the cock 204.

Rotation of the cock 204 may generate a reaction force within the access port 200. The reactive force within the access port 200 enables one-handed operation. The access port 200 enables the administration line 140 to be parallel to the side of the container 100 in the standby position.

Referring now to FIG. 3A, in another embodiment of the invention, an access port 300 may have four different portions, a valve 302, a threaded shell 304, a perforator 306, and a gasket 308. The perforator 306 of the access port 300 may be in a standby position. Any of the four different portions of the access port 300 will be described in greater detail below.

Referring to FIG. 3B, the valve 302 may be molded from a blend, for example, having an elastic modulus of about 900MPa, which provides six functions. First, the valve 302 is capable of sealing the access port 300 to the film 150 of the container 100. The valve 302 may be surrounded by a peripheral base 310. The peripheral base 310 has a thickness 311 and is ultrasonically welded to the film 150 of the container 100. Second, the valve 302 may enable axial guidance of the perforator 306. The valve 302 may have a cylindrical hollow shaft 312 for axially guiding the perforator 306. Third, the valve 302 may be capable of placing the perforator 306 in a standby position and an activated position. Two cantilever beams 314a and 314b extend from a top 316 of the valve 302. The two cantilever beams 314a and 314b may prevent the perforator 306 from being withdrawn from the valve 302.

Referring to FIG. 3C, the two cantilever beams 314a and 314b may clamp the perforator 306 in a standby position in the open position shown. Fourth, a perforator guiding system may be used in the valve 302. Two slots 318a and 318b are provided for receiving the arms 320a and 320b of the perforator 306. Arms 320a and 320b are shown in fig. 3C, 3D, and 3E. The slots 318a and 318b may prevent the perforator 306 from rotating within the valve 302. Fifth, the valve 302 has a threaded portion 319 for guiding and/or mating with the threaded housing 304. Finally, as shown in FIG. 3C, the perforator 306 may have two tabs 321 for securing the assembly in the activated position. The two tabs 322 on the valve 302 may prevent the threaded shell 304 (see FIG. 3A) from rotating, either in the standby position or during translation of the perforator 306 to the activated position, as shown in FIG. 3D.

Referring to FIG. 3E, the perforator 306 may be molded from, for example, a blend having a modulus of elasticity greater than 1500 MPa. The perforator 306 may have at least five functions. First, the perforator 306 may puncture the film 150 of the container 100 and open a path for the solution within the container 100 to be drawn. The tip 323 of the perforator 306 may have a tri-slope bevel 324. The tri-slope bevel 324 may puncture and/or tear the film 150 below the perimeter base 326 of the valve 302. Also, the tri-slope bevel 324 can generate minimal friction.

Second, the perforator 306 may connect the container 100 to the administration line 140. The perforator 306 may have a press-fit shaft 307 for press-fitting and/or bonding with the administration line 140. The perforator 306 may be hollow. After puncturing the film 150, the perforator 306 may create a fluid path from the container 100 to the administration line 140.

Third, the perforator 306 may have axially external beams or cantilever beams, or arms 320a and 320b that lock into the slots 318a and 318b of the valve 302 to prevent any rotation of the perforator 306 during activation. Fourth, the perforator 306 may have a gasket groove 327, a gasket 308 and a guiding flange 328. The gasket groove 327 and the guide flange 328, in combination with the cylindrical hollow shaft portion 312 of the valve 302, ensure the axial guidance of the assembly and the liquid-tightness of the assembly.

Fifth, the perforator 306 may have a stop ring 340 that may axially engage the threaded shell 304 of the valve 302, where the threaded shell 304 is substantially fixed but has rotational freedom. Moreover, the gasket 308 may ensure the liquid-tight performance of the assembly and avoid any contaminants from entering the sterile fluid path.

Referring to fig. 3F, 3G, and 3H, the threaded shell 304 may be molded from a blend, for example, having an elastic modulus of about 1000 Mpa. The threaded shell 304 serves at least three functions. First, the threaded housing 304 can reduce the force required to puncture the membrane 150 of the solution container 100 by providing two threaded wings 340a and 340 b. Fingers and/or hands of an operator may be placed on the threaded wings 340a and 340 b. Second, the threaded shell 304 may activate the perforator 306 when rotated by engaging an internal thread 342 in the threaded shell 304 with a thread on the valve 302.

Third, the threaded shell 304 may have a crown 345 removably attached to the threaded shell 304, wherein the crown 345 may provide shielding. More specifically, in the standby position, as shown in FIG. 3A, the crown 345 of the threaded shell 304 is located on the upper surface of the valve 302 and is connected to the body of the threaded shell 304 by the frangible portion 344. The threaded shell 304 will cause the frangible portion 344 to tear as it is threaded. The frangible portion 344 can provide evidence that the threaded housing has been screwed through. The frangible portion 344 may remain connected to the access port 300 after the crown 345 is separated from the threaded shell 304.

Accordingly, rotating the threaded shell 304 in a clockwise direction can tear the frangible portion 344 thereby separating the protective crown 345. Rotating the threaded shell 304 may engage the valve 302 and the perforator 306. After detaching the protective crown 345, an axial stroke of the perforator 306 may be induced. The axial stroke of the perforator may cause the perforator 306 to puncture and embed in the container 100. After the perforator 306 pierces the container 100, the access port 300 may be locked in an activated position and the perforator 306 may not be withdrawn.

The threaded shell 304 may be locked to the valve 302 such that the threaded shell 304 may rotate without affecting the perforator 306 and the valve 302. A reactive force may be created within the access port 300 due to the axial stroke of the perforator 306. The reaction force developed within the access port 300 enables one-handed operation during actuation of the access port 300.

Referring now to FIG. 4A, an access port 400 in another embodiment of the present invention is shown. The access port 400 may be constructed from three components, a valve 402, a perforator 404, and a gasket 406. The valve 402 may be molded from a blend, for example, having an elastic modulus of about 900 Mpa. And the valve 402 has at least five functions. First, the valve 402 can seal the access port 400 to the film 150 of the container 100. The valve 402 has a peripheral base 408 having a thickness 409, the peripheral base 408 being ultrasonically welded to the film 150 of the container 100.

Second, the valve 402 may enable axial guiding of the perforator 404. The valve 402 may have a cylindrical hollow shaft 410 surrounded by a crown 412. Third, the valve 402 has a perforator locking system 405 in both the standby and activated positions as shown in figures 4B and 4C, respectively. On the outside of the valve 402, external latches 416 are provided for establishing the standby position and the activated position. In the activated position, the access port 400 may be locked.

Fourth, the valve 402 may form a fluid path and connect the administration line 140 with the container 100. The valve 402 has a press-fit shaft portion 418 for engaging the administration line 140. Finally, the valve 402 may have a finger pad 420 for indicating where the operator's finger is placed. The finger pad 420 is capable of concentrating the force applied around the valve 402.

The perforator 404 may be molded from, for example, a blend having an elastic modulus greater than 1500Mpa and may have at least six functions. First, the perforator 404 may puncture the film 150 of the container 100 and open a path for the solution within the container 100 to be drawn. The tip 421 of the perforator 404 may have a tri-slope bevel 422. The tri-slope bevel 422 may be designed to puncture and tear the film 150 under the peripheral base 408 of the valve 402 with minimal friction. Second, the perforator 404 may have a gasket groove 426 and a guide 428. The gasket groove 426, gasket 406, and boot 428, in combination with the cylindrical hollow shaft portion 410 of the valve 402, may provide guidance in the axial direction and ensure fluid-tight sealing of the access port 400. Third, the perforator 404 may have a blunt hollow shaft 430 from the tip 421 through a middle 431 of the axial extension of the perforator 404. Also, a window 432 in the hollow shaft 430 enables solution to flow from the container 100 into a body 434 of the valve 402.

Fourth, the perforator 404 may have an integrally formed cantilever beam 436, the cantilever beam 436 having a catch 438 that mates with the external latch 416 provided on the valve 402. Rotation of the shaft 430 of the perforator 404 inside the valve 402 may be avoided. Further, an arm 442 may be provided on the outside of the perforator 404 to maintain the perforator 404 in a standby position and an activated position, as shown in figures 4B and 4C, respectively. In the activated position, the access port 400 may be locked.

Fifth, the arm 442 may have a safety tab 444 that may lock the perforator in a standby position and prevent inadvertent activation of the perforator. The rupture disc 444 is removably attached to the arm 442 and can be removed by breaking the connection between the disc 444 and the arm 442. Finally, the catch 438 and the latch 416 of the perforator 404 when snap-fit may generate an audible signal and/or prevent further withdrawal of the perforator 404. The gasket 406 can maintain the liquid-tight properties of the assembly and/or can prevent contaminants from entering the sterile fluid path.

Removal of the safety tab 444 may allow an axial stroke of the perforator 404. After the perforator 404 is activated, the perforator 404 may be embedded into the valve 402 such that the perforator 404 may not be easily withdrawn. A reactive force may be generated within the access port 400 due to the axial stroke of the perforator 404. The reactive force within the access port 400 may allow for one-handed operation in making the connection and may also avoid the additional need to hold the container.

Referring to FIG. 5A, in another embodiment of the present invention, an access port 500 is shown. The access port 500 may be constructed from a valve 502, a perforator 504, a gasket 506, and a shell 508. The perforator 504 of the access port 500 is in a standby position.

Referring to FIG. 5B, the valve 502 may be molded from a blend, for example, having an elastic modulus of about 900 MPa. The valve 502 has at least four different functions. First, the valve 502 is capable of sealing the access port 500 to the film 150 of the container 100, as shown in FIG. 5D. The valve 502 may be surrounded by a peripheral base 510 having a thickness 511 to ultrasonically seal the access port 500 to the film 150 of the container 100. Second, the valve 502 may axially guide the perforator 504. The valve 502 provides a cylindrical hollow shaft portion 516 having four axially outer flanges 514. The axially outer flange 514 may form two axial runners 512.

The axially outer flange 514 and the axial runner 512 are described in more detail below.

Third, as shown in figures 5A and 5D, respectively, the valve 502 may lock the perforator 504 in a standby position and an activated position. At the ends of the two axial slots 512, two catches 548 may lock the perforator 504 in a standby position.

Fourth, the valve 502 may connect two housings 508. The valve 502 may have two diametrically opposed knuckles 540 at right angles to the groove 512. The articulation 540 may provide an axis 546 about which the shell 508 rotates.

Referring to FIG. 5C, the perforator 504 may be molded from, for example, a blend with a modulus of elasticity greater than 1500 MPa. The perforator 504 may provide five functions. First, the perforator 504 may puncture the film 150 of the container 100 and open a path for the solution within the container 100 to be drawn. The tip 518 of the perforator 504 may have a tri-slope bevel 520 designed to puncture and/or tear the film 150 located below the peripheral base 510 of the valve 502. The tri-slope bevel 520 of the tip 518 may provide minimal friction between the perforator 504 and the film 150.

Second, the perforator 504 may create a fluid path between the container 100 and another object, such as a patient or a second container, etc. Further, the perforator 504 may connect the administration line 140 to the container 100. The perforator 504 is hollow and has a shaft 522 for engaging the administration line 140. Third, the perforator 504 may have a gasket groove 526, a gasket 506 and a guiding flange 528, which in combination with the cylindrical hollow shaft 516 of the valve 502 may ensure that the guiding is provided in the axial direction and that the liquid sealing between the perforator 504 and the valve 502 is ensured. Moreover, the gasket 506 may ensure a fluid-tight seal between the perforator 504 and the valve 502 and may prevent contaminants from entering the sterile fluid path from the container 100 to the administration set

Fourth, the perforator 504 may have a plateau 550 perpendicular to the axis of the perforator 504. Also, the perforator 504 may have two sliding grooves 552 that translate the clamping motion of the shell 508 into a force exerted on the perforator 504. Fifth, the two cantilever beams 554 are capable of mating with the slots 512 of the valve 502. The cantilever beams 554, in cooperation with the slots 512, prevent the perforator 504 from rotating within the cylindrical hollow shaft 516 of the valve 502. More specifically, the catches 548 at the ends of the slots 512 can form a lock with the latches 556 on the cantilever beams 554. The latches 556 of the cantilever beams 554 may lock the perforator 504 in the standby and activated positions in the valve 502. Prior to use, the two tabs 549 (shown in FIG. 5C) lock the perforator 504 in a standby position.

Referring to FIG. 5A, the shell 508 may be molded from a blend having, for example, a modulus of elasticity greater than 2000 MPa. The housing 508 serves five functions. First, the housing 508 is provided with finger pads 558. In use, the finger pads 558 can focus the clamping force applied by the operator. Second, the housing 508 has an articulation 560 for mating the housing 508 with the valve 502. The knuckle 560 has two protrusions 562 for limiting the position of the shell to an angled standby position, as shown in FIG. 5A.

Third, the shell 508 has a beam 564 that rests within the sliding grooves 552 of the plateau 550 of the perforator 504. The beam 564 can translate the force applied by the operator into a translational motion. More specifically, the tip 566 of the beam 564 can slide into the sliding slot 552 of the plateau 550.

Fourth, the latch and catch 568 are disposed inside the housing 508 at the distal end 570 of the housing 508. When each shell 508 is snap-fit together, the latch and catch 568 latch and rattle. The sound provides an audible message that the housing 508 has been locked. Also, when snap-fit together, the latch and catch 568 prevent the housing 508 from being reopened and/or separate the housing 508. Fifth, when closed together, the shell 508 may form a cylinder around the activated perforator 504, which encloses the access port 500, as shown in figure 5D.

Closing the shell 508 may cause an axial stroke of the perforator 504. Separating the shell 508 or moving the shell 508 after the shell 508 is locked may not move the perforator 504. The ratio of the pivot lengths (ratio of a pivot lengths) enables the access port 500 to reduce the force required to puncture the membrane 150 of the container 100. The reaction force is enhanced at the access port 500 due to the locking of the housing 508. The reaction force in the access port 500 enables one-handed operation.

The present invention can allow for one-handed operation and can provide an audible and visual cue when a tri-slope bevel has punctured the film 150 to allow solution to flow from the container 100. Moreover, the present invention can prevent contamination by completely closing the fluid forming passage from contact and contamination from airborne contaminants and not allowing the perforator or plunger to be removed from the fluid engagement position after engagement is made. Even more, the present invention can reduce the amount of force required to puncture the film of the container.

It should be understood that various changes and modifications to the current embodiments described herein will be apparent to those skilled in the art to which the invention pertains. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended scope. It is therefore intended that such changes and modifications be included within the scope of the appended claims.

Claims (18)

1. A container, comprising:

a film folded to form side edges and sealed to define an interior space; and

a port having an outlet port through which fluid communication is established with the interior space; characterized in that the port comprises:

a valve having a housing defining an interior space, the valve surrounded by a peripheral base sealed to the membrane;

a shoulder on the housing;

a cock connected to the valve and guided axially by a shoulder of the housing; and

a plunger having a hollow shaft portion and a tip, wherein the plunger is located inside the valve, and wherein rotational movement of the cock forces the plunger to protrude from the inside of the valve and forces the tip to pierce the membrane; and the container further comprises:

a flap releasably connected to the port, wherein separation of the flap establishes fluid communication with the interior space and allows the plunger to pierce the membrane.

2. The container of claim 1, wherein the plunger is in fluid communication with the interior space when the membrane is pierced by the plunger.

3. The container of claim 1, wherein the tab is connected to the plunger and is separated from the plunger after the plunger pierces the film.

4. The container of claim 1, further comprising:

a housing having a first portion coupled to a second portion forming a sheet, wherein the first portion is separated from the second portion to provide fluid communication with the interior space.

5. The container of claim 1, wherein when the plunger is locked in an activated position, the cock is locked in an activated mode, thereby generating an audible signal.

6. The container of claim 1, further comprising:

a conduit having a first end and a second end, wherein the first end is connected to the port.

7. A port for establishing fluid flow from a container to an administration set, the port comprising:

a valve having a housing defining an interior space thereof;

a shoulder on the housing;

a cock connectable to the valve and guided axially by a shoulder of the housing;

a catch on the valve for locking the plug, wherein locking the plug produces a sound; and

a plunger having a hollow shaft portion and a tip, wherein the plunger is located inside the valve and rotational movement of the tap forces the plunger to protrude from the interior of the valve and force its tip to pierce the container, and wherein when the tap is locked the tip of the plunger is locked in the container.

8. The port of claim 7, further comprising:

a washer located on the ram.

9. The port of claim 7, further comprising:

a removable tab on the cock that blocks rotation of the cock.

10. The port of claim 7, further comprising:

a knob connected to the plunger and which guides the plunger within the valve and which also prevents the plunger from rotating.

11. The port of claim 7, further comprising:

a peripheral base integrally formed with the valve, wherein the peripheral base is sealed to the container.

12. A method for establishing fluid flow between a container and an administration set, the method comprising the steps of:

providing a port as claimed in claim 1;

connecting the port with the container;

sealing the valve of the port to the container;

rotating the plug such that the plug exerts a force on the plunger;

piercing the container with a plunger;

locking the cock and the plunger in a certain position; and

an audible signal is generated when the cock and the plunger are locked in place.

13. The method of claim 12, further comprising the steps of:

a gasket is provided wherein the gasket is used to maintain a seal between the plunger and the valve.

14. The method of claim 12, further comprising the steps of:

a tab is provided on the tap.

15. The method of claim 14, further comprising the steps of:

the tab is removed from the tap.

16. The method of claim 12, further comprising the steps of:

a conduit is provided that is connectable to the faucet.

17. The method of claim 12, further comprising the steps of:

the plunger is inserted into the container.

18. The method of claim 12, further comprising the steps of:

locking the cock into the valve.