HK1167591B - Access port - Google Patents

Description

Access port

The present application is a divisional application of the invention patent application having application number 200680018256.9, filing date 23/5/2006 entitled "access port with safety tab and fluid container employing the same".

Technical Field

The present invention relates generally to a container, an access port and a method for establishing flow between the container and an administration set. The access port may provide for the flow of fluid from the container into the appropriate administration set. More specifically, a valve or base is provided that seals to the container. A perforator or plunger in the valve pierces the container and provides access to the solution in the container.

Background

Containers for the infusion of medical solutions are well known. Generally, these containers are made of flexible films that are folded and sealed together along the peripheral side edges. In addition, these containers typically have an inlet and an outlet. These containers also typically have a means for piercing the output port and establishing fluid communication between the device and the solution within the container. The solution may then be expelled from the device to an infusion set and/or patient.

Maintaining the sterility of the medical solution to be infused into the patient is extremely important. However, handling of medical solution containers can pose a risk of contamination. In emergency situations, the risk of such contamination may increase, wherein rapid manipulation of the various components may introduce bacteria or other pathogens into the container. For example, a user may inadvertently contact and/or contaminate a sterile face of an input port or an output port. The contamination may then be transferred to the contents of the container.

In addition, containers for the infusion of medical solutions are generally flexible. Thus, aseptic connection to a flexible container to extract the contents in an aseptic manner can be difficult. For example, U.S. patent No. re.29,656 to Chittenden et al discloses an additional transfer unit having a tubular member sealed to a solution container. The unit includes a needle that pierces the stopper of the solution container. It is difficult to obtain a liquid-tight and leak-proof connection through a flexible container using conventional medical connectors, such as needles or piercing pins.

In addition, the infusion port is fixedly coupled to the flexible container. However, the infusion ports of known flexible solution containers are often the weakest part of the container. Thus, certain medical solutions that are sensitive to oxygen and/or other permeating gases may be damaged. In addition, pre-formed infusion ports constitute potential leak sites and potential contaminant entry points.

Other means for establishing fluid communication between the container and the administration set are also known. Generally, known access ports require a two-handed access port and do not produce audible or visible notifications when the access port is fully engaged. In addition, many of the known access ports are substantially incapable of preventing contact and airborne contaminants.

Accordingly, a need exists for a formed, filled, sealed solution container with an access port and a method for establishing flow between the container and an administration set. Accordingly, there is a need for a medical solution container having improved inlet and outlet ports to reduce the likelihood of contamination during storage and/or use. In addition, there is a need for a medical solution container and access port having improved ease of handling. Additionally, there is a need for a solution container and access port having a liquid-tight seal to avoid leaks, reduce contact and/or airborne contamination, and reduce permeation of oxygen and/or other gases.

Disclosure of Invention

The present invention provides a formed, filled, sealed solution container with an access port and a method for establishing fluid communication between the container and an administration set. More specifically, the access port is sealed to the container and has means for piercing the container. Fluid in the container moves from the container through the port to the administration line. The infusion line further transports the fluid to an infusion device.

The port may have a valve and a perforator. The valve may include a peripheral sealing flange or ring that may allow sealing to the container. The valve may define a cylindrical opening that may receive and slidingly engage a perforator or plunger. The cylindrical opening may guide the perforator or plunger to pierce the container and open access to the solution contained within the container. The perforator or plunger may have a hollow shaft comprising a tri-slope bevel (tri-slope) on the end facing the container film. The tri-slope bevel of the perforator or plunger pierces and tears the stretched film of the container below the sealing flange of the valve.

The present invention can provide one-handed operation and provide audible and visible notification when the tri-slope bevel pierces the film allowing solution flow. In addition, the present invention can completely cover the fluid generation path to exclude contact and airborne contamination. The present invention can further reduce the amount of force required to penetrate the container film. Additionally, the perforator or plunger of the present invention may not be removed from the fluid engagement position after engagement is achieved.

In a preferred embodiment, an access port is provided that enables access to a container holding a solution (such as a plastic bag holding sterile medical fluid). The container may be constructed in a forming, filling and sealing operation and may be constructed, for example, from clearflex (tm) material. The container may include, for example, a peritoneal dialysis solution or other solution for use in continuous kidney replacement therapy ("CRRT"). The access port provides for the flow of fluid from the container into, for example, a corresponding administration set.

The access port includes: (i) a perforation assembly and (ii) a valve. The valve may be sealed to the container. The valve may include a peripheral sealing flange or ring that allows for the acoustic sealing of the access port (for example) to the container membrane. The valve receives and slidingly engages the perforation assembly. The perforation assembly includes a perforator and a shell. The perforator moves within the shell of the perforation assembly to pierce the container and open access to the solution contained within the container.

The perforator is a hollow shaft comprising a beveled cone on the end facing the container. The beveled cone of the perforator pierces and tears the wall of the container contained within the valve.

The access port allows for one-handed operation and provides audible and visible notification when the bevel cone pierces the container to allow solution flow. The access port completely covers the fluid generation path to exclude contact and airborne contamination. The access port reduces the amount of force required to penetrate the container and prevents removal of the perforator from the fluid engagement position after engagement is achieved.

The access port operates with a medical fluid container that contains a valve sealed to the wall of the container. The access port includes a housing. The housing is secured to the valve of the container. Specifically, the housing includes a snap-fit base on a valve sealed to the solution container.

The shell 12 encloses the perforator. The perforator extends out of the top of the shell and includes a threaded end that is initially protected by a nut. The perforator also includes a removable safety or tamper proof tab. When the tab is connected to the perforator, the operator is prevented from pressing the rotatable arm of the shell inward, which action pushes the perforator downward relative to the shell of the access port. With the access port installed in the valve and the safety tab (safety tab) removed, the arms may be pressed inward to cause the perforator to move and pierce the valve of the solution container. The operator may then connect a device, such as an infusion set, with a luer connector (luer connector) in a fluid tight manner to the perforator by removing the screw cap and connecting the device via threads on the top of the perforator.

The safety tab includes a ring extending around a circular flange that projects radially outward from the hollow shaft of the perforator. The ring is connected to the flange at a plurality of (e.g., eight) weak points. The ring of the safety tab is also connected to the handle. The operator grasps the handle and tears the ring from the circular flange by breaking the eight points or fixtures. The flange has a diameter less than the inner diameter of the hollow shell such that the flange and associated perforator can move within the shell after the ring and the handle are removed from the flange.

For the purposes described above, in one embodiment a container is provided. The container has a film, a port, and a tab. The film is folded to define sides and the sides are sealed to define an interior. The port defines an output port through which fluid communication is established with the interior. The tab is attached to the port and the tab confirms the formation of fluid communication with the interior.

In this first embodiment, the tab of the container may be separated from the port after fluid communication is established. The container may have a perforator attached to the port, wherein the tab is attached to the perforator and attached to the port, and further wherein the tab is detached from the perforator after fluid communication is established. The container may also have a housing having a first portion attached to a second portion defining the tab, wherein separation of the first portion from the second portion confirms formation of fluid communication. The container additionally has a cock attached to the port, wherein the tab is attached to the cock, and further wherein the tab is removed from the cock before fluid communication is established. Confirming the formation of fluid communication through the tab may produce an audible notification. In addition, the container may have a line having a first end and a second end, wherein the first end is attached to the port.

In a second embodiment, a port for establishing fluid flow from a container to an administration set is provided. The port has a valve with a housing defining an interior, a shoulder on the housing, a cock, a catch, and a plunger. A tap may be attached to the valve and may be axially guided by a shoulder of the housing. A bayonet on the valve locks the cock and locking the cock produces a sound. The plunger has a hollow shaft and a tip. The plunger is inside the valve and rotation of the cock forces the plunger to protrude from the valve interior and forces the tip to penetrate the container. The tip of the plunger is locked in the container after the tap is locked.

In this second embodiment, the port may have a washer on the plunger and/or a removable tab on the cock, wherein the tab prevents rotation of the cock. The port may also have a protrusion (knob) associated with the plunger, wherein the protrusion guides the plunger in the valve and, in addition, the protrusion prevents the plunger from rotating. The port may also have a peripheral foot integrally formed with the valve, wherein the peripheral foot is sealed to the container.

In a third embodiment, a method for establishing flow between a container and an administration set is provided. The method comprises the following steps: (i) providing a port having a valve, a cock, and a plunger, wherein the valve has an interior for receiving the cock and the plunger; (ii) attaching the port to the container; (iiii) sealing the valve of the port to the container; (iv) rotating the cock such that the cock exerts a force on the plunger; (v) piercing the container with the plunger; (vi) locking the cock and plunger in place; and (vii) an audible notification when the rotation is locked in place with the plunger.

In this third embodiment, the method may further comprise: (viii) providing a gasket, wherein the gasket is utilized to maintain a seal between the plunger and the valve; (ix) a tab provided on the cock; (x) Removing the tab from the cock; (xi) Providing a line attachable to a tap; (xii) Inserting the plunger into the container; and/or (xiii) locking the cock into the valve.

In a fourth embodiment, a port for establishing fluid flow from a container to an administration set is provided. The port has a valve with a shaft, a perforator with an arm, wherein the perforator is axially guided by the shaft of the valve, a cantilever beam protruding from the valve, and a shell. The cantilever beam prevents the perforator from leaving the valve. The housing has a first portion attached to a second portion. The shell engages the valve and forces the perforator to pierce the container and the first portion of the shell separates from the second portion of the shell after the perforator pierces the container.

In this fourth embodiment, the port may further include: (i) a gasket on the perforator, wherein the gasket provides a seal between the perforator and the valve; (ii) a finger pad on the first portion of the housing; (iii) a slot on the valve for receiving an arm of a perforator; (iv) a flange on the perforator for guiding the perforator in the shaft of the valve; (v) a protrusion on the valve, wherein the protrusion mates with the housing; and/or (vi) a flap on the shell, wherein the shell is manipulated by applying a force to the flap.

In a fifth embodiment, a method for establishing flow between a container with a port and an administration set is provided. The method comprises the following steps: (i) providing a valve, a perforator and a shell, wherein the valve has an interior and the perforator is inside the valve, and further wherein the perforator protrudes from the valve; (ii) sealing the valve to the container; (iii) attaching the housing to a valve; (iv) forcing the perforator to pierce the container by rotating the shell; (v) piercing the bag with a perforator; (Vi) locking the perforator in place; and (vii) maintaining a seal between the perforator and the valve.

In this fifth embodiment, the method may further comprise: (viii) rotating the shell, wherein rotation of the shell produces an axial stroke of the perforator; (ix) embedding the perforator in the container; and/or (x) locking the perforator in the valve.

In a sixth embodiment, a port for establishing fluid flow from the container is provided. The port has a valve with 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 detent and a latch on the valve mates with the detent of the beam. The cooperation of the latch and the catch locks the perforator.

In this sixth embodiment, the cooperation of the latch with the catch may generate a sound and the perforator may be hollow. Also, the port may further comprise a line attached to the shaft of the valve and/or an arm on a beam for locking the perforator in the valve.

In a seventh embodiment, a method for establishing fluid flow between the container and an administration set is provided. The method comprises the following steps: (i) providing a port having a gasket, a valve, and a perforator, wherein the valve has an interior and further wherein the perforator is in the interior of the valve; (ii) sealing the valve of the port to the container; (iii) applying pressure to the perforator and forcing the perforator to pierce the container; (iv) locking the perforator with the valve in an activated position; and (v) maintaining a seal between the perforator and the valve with a gasket.

The method may further comprise: (vi) breaking the seal between the valve and the container; (vii) attaching a line to the valve; and/or (viii) locking the perforator in the valve to prevent rotation of the perforator.

In an eighth embodiment, a port for establishing fluid flow from the container to an administration set is provided. The port has a valve defining a shaft, a perforator in the shaft of the valve, a first side wing and a second side wing, a latch on the first side wing, and a catch on the second side wing. The valve is sealed to the container and the latch locks onto the catch. The first wing is diametrically opposed to the second wing and is attached to the valve. Additionally, the first and second wings contact the perforator, wherein rotation of the first and second wings forces the perforator to move toward the container.

In this eighth embodiment, the locking of the latch with the detent may produce an audible notification. The port may also include a slot on the valve, wherein the slot has a lock for locking the perforator.

In a ninth embodiment, a method for establishing flow between a ported container and an administration set includes: (i) providing a valve having a shaft, wherein the valve is sealed to the container, (ii) providing a perforator in the shaft of the valve; (iii) rotating a first wing and a second wing toward each other, wherein the first wing and the second wing are diametrically opposed and attached to the valve, and further wherein the first wing and the second wing contact the perforator; (iv) piercing the container with the perforator; and (v) locking the first side wing and the second side wing. The method may also include locking the perforator to the valve.

In a tenth embodiment, an access port is provided and includes: (i) a housing; (ii) a perforator within the shell, the perforator comprising an end configured to pierce a medical fluid container; and (iii) a safety tab connected to the perforator, the safety tab preventing the perforator from piercing the medical fluid container, the safety tab manually removable to enable the perforator to pierce the medical fluid container.

In this tenth embodiment: (i) the housing may include a portion configured to attach to the valve, wherein the valve is sealed to a fluid container; (ii) if the end of the perforator is a first end, the perforator may include a second end configured to connect to a fluid delivery tube; (iii) a protective cap may be placed over the second end; and (iv) wherein at least one arm may be pivotally connected to the shell, the arm contacting the perforator such that when pivoted the arm moves the perforator relative to the shell.

Also in this tenth embodiment, the safety tab may comprise a ring that initially prevents the perforator from piercing the fluid container. The ring may be connected to the perforator by a plurality of frangible fixtures. The geometry of each anchor may be configured such that the tear strength caused by the anchor is minimal in a direction at least substantially parallel to the perforator.

Also in this tenth embodiment, a flange may extend from the perforator, wherein the ring is connected to the flange by a plurality of frangible fixtures. Here, the geometry of each retainer may be configured such that the tear strength caused by the retainer is minimal in a direction at least substantially perpendicular to the flange. The flange may be sized to pass through the housing and wherein the ring connected to the flange is sized not to pass through the housing. The safety tab may include a handle connected to the ring, the handle configured to be manually grasped and pulled.

In an eleventh embodiment, a medical fluid container assembly is provided and includes: (i) at least one flexible membrane forming a fluid tight container; and (ii) an access port configured to be engaged to the container, the access port including a safety tab that prevents a film from being pierced, the safety tab including a plurality of frangible fixtures that collectively provide a suitably high tamper resistance force, the fixtures individually providing a suitably low removal force.

In this eleventh embodiment, the access port may include a perforator and a shell, wherein the safety tab is removably connected to the perforator, and the shell is configured to connect to the container. The assembly may be provided to a customer in a non-assembled manner, wherein the access port is separate from the container. The container may hold a medical fluid selected from dialysate, saline. At least one of the fixing portions may: (i) has a tetrahedral shape; (ii) configured to narrow toward the point contact frangible interface; (iii) connecting the safety tab to the perforator, wherein the safety tab abuts against the shell to prevent the perforator from piercing the film; and (iv) provide a portion of the total resistance to the intervention force.

In a twelfth embodiment, an access port is provided and includes: a perforator comprising an end configured to pierce a medical fluid container; and a shell external to the perforator, the shell including a shell and a pair of arms (i) hingedly connected to the shell and (ii) extending angularly offset from the shell toward a piercing end of the perforator, the shell further including members each having a first end hingedly connected to one of the arms and a second end adjacent the perforator, the members being operable to push the perforator toward the medical fluid container when the arms are pushed toward the shell of the shell.

In this twelfth embodiment, the members are each configured to perform at least one of the following: (i) attached to the middle section of one of the arms; and (ii) abutting a flange extending from the perforator. The perforator and the shell may be configured to provide at least one of: (i) audible feedback when the perforator is moved relative to the shell; (ii) tactile feedback when the perforator is moved relative to the shell; and (iii) a locking engagement when the perforator is moved to a piercing position relative to the shell.

It is therefore an advantage of the present invention to provide a formed, filled, sealed solution container, port and method of one-handed flow between the container and an administration set.

Another advantage of the present invention is to provide a formed, filled, sealed solution container, port and method of establishing flow between the container and an administration set in which an audible notification is generated when the access port is fully engaged.

It is a further advantage of the present invention to provide a formed, filled, sealed solution container, port and method of establishing flow between the container and an administration set in which a visual notification is provided when the access port is fully engaged.

It is a further advantage of the present invention to provide a formed, filled, sealed solution container, port and method for establishing flow between the container and an administration set in which the access port excludes contact and airborne contaminants.

It is a further advantage of the present invention to provide a formed, filled, sealed solution container, port and method of establishing flow between the container and an administration set wherein the access port provides a design having an activated mode and wherein the user's fingers and/or hand position is direct (straight forward).

It is 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 administration set wherein the access port reduces the force required to access the container.

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

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

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

It is a further advantage of the present invention to provide an access port connectable to a medical fluid bag, wherein the access port includes a safety tab that prevents inadvertent puncturing of the bag prior to removal of the safety tab and punctures the bag after removal of the safety tab.

A further advantage of the present invention is to provide a visual indication of whether a medical fluid bag can be pierced by an access port.

Additionally, it is an advantage of the present invention to provide an access port with a safety tab that provides an effective inhibitor of inadvertent puncturing of the bag, yet is relatively easy to remove.

Additional features and advantages of the present invention are described in, and will be apparent from, the detailed description of the presently preferred embodiments and the accompanying drawings.

Drawings

FIG. 1 illustrates a perspective view of a container with an access port in an embodiment of the present invention.

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

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

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

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

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

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

FIG. 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.

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

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

FIG. 3H illustrates a perspective view of the housing of the 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.

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

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

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

FIG. 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.

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

FIG. 6 is a perspective view of one embodiment of a medical fluid container, valve, and access port with a safety tab of the present invention.

Fig. 7 is another perspective view of the fluid container, valve, and access port with a safety tab of fig. 6.

Fig. 8 is a side view of the access port of fig. 6 and 7 with a safety tab.

FIG. 9 is a side cross-sectional view of the access port with the safety tab of FIGS. 6, 7, and 8 in a non-piercing position.

FIG. 10 is a side cross-sectional view of the access port with the safety tab of FIGS. 6, 7, and 8 in a piercing position.

FIG. 11 is a plan view showing a plurality of frangible fixtures of the safety tab of the access port of FIGS. 6-10.

Fig. 12 is a perspective view of one example of the frangible fixation portion of fig. 11.

Detailed Description

The present invention relates generally to a container with an access port and a method for establishing flow between the container and an administration set. The port may be sealed to the container and may pierce the container to provide access to the solution in the container. The solution may be withdrawn from the container into the interior of the port, wherein a line connecting the port to the administration set may further withdraw the solution into the administration set.

Referring now to the drawings, in which like numerals refer to like parts, FIG. 1 illustrates a container 100 a. The container 100a 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 solution and then sealed along the top to form a sealed fluid-filled container. The container 100a may be constructed of a transparent material, such as clearflex. The container 100a may include a solution, for example, a peritoneal dialysis solution. The container 100a may have an input port 120 for receiving an additive. The input port 120 may have an injection site protected by a plastic cap.

The container 100a may also have an output 130 for providing medical solution to a patient. The output port 130 may have a liner constructed of an elastomeric material (e.g., a membrane 150) inserted between an end face of the output port 130 and the access port 160. The membrane 150 of the output port 130 may be engaged by the access port 160 to establish fluid communication between the access port 160 and the container 100 a. In addition, an infusion line 140 may connect the container 100a to a subject, such as a patient, other bag, or the like. A fluid path may be created by connecting the administration line 140 to the container 100a and the subject. Infusion line 140 may be connected to container 100a through access port 160. As illustrated in fig. 1, the container 100a may be operable with different access ports, such as the access ports 10, 200, 300, 400, and 500 described herein.

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

Referring now to fig. 2B, the plunger 206 of the access port 200 is shown 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. Rotation of the cock 204 may force the plunger 206 downward and/or pierce the container 100 a.

Referring to fig. 2C, the valve 202 may be molded from a mixture that ensures a variety of different functions, e.g., an E-modulus of about 900MPa, for example. The valve 202 may be surrounded by a peripheral foot 210, which peripheral foot 210 may be sonically sealed to the membrane 150 of the solution container 100 a. The foot 210 may prevent leakage of medical solution from the container 100 a. 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 may be designed to create a standby position and an activated position of the plunger 206, as shown in fig. 2A and 2B, respectively. Preferably, a lock 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 shown 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 illustrated with the plunger 206 locked in an activated position, i.e., the cock 204 is in a substantially vertical position and the plunger 206 protrudes from the valve 202. Additionally, the valve 202 may include a latch that may lock the cock 204 in the activated mode. Locking the cock 204 may generate a sound to provide an audible notification that the cock 204 is locked.

Referring to fig. 2E, the plunger 206 can be molded from a mixture that includes an E-modulus greater than 1500MPa, for example. The plunger 206 may provide at least three functions. First, the plunger 206 may pierce the membrane 150 of the container 100a and may open an inlet to the solution. The tip 216 of the plunger 206 may be designed to pierce and/or tear the membrane 150 under the peripheral foot 210 of the valve 202. More specifically, the plunger 206 may be shaped as a hollow cylinder that tapers from a first end 203 to a second end 205 of the plunger 206. The outer surface 215 of the plunger 206 may have a first cut 217 and a second cut 219, the first cut 217 and the second cut 219 being disposed at an angle to each other at the second end 205 of the plunger 206 to define a tip 216. The second end 205 with the first cut 217 and the second cut 219 define a tri-slope bevel (vevel)218 of the tip 216. Additionally, the design of the tri-slope bevel 218 of the tip 216 of the plunger 206 may produce minimal friction.

Second, the plunger 206 may allow solution to flow from the container 100a into the valve 202 through the hollow shaft 220 of the plunger 206. Third, the plunger 206 may have axial and external beams 222 that may guide the plunger 206 into the valve 202 during activation of the access port 200. The axial and outer beams 222 may have two protrusions 224a and 224 b. The axial and outer beams 222 and the two projections 224a and 224b may guide the plunger 206. The protrusions 224a and 224b prevent the plunger 206 from rotating. In addition, the protrusions 224a and 224b may position the plunger 206 in the standby position and the activated position. Preferably, a lock may be provided to lock the plunger 206 in either the standby position or the activated position.

Referring to FIG. 2D, the cock 204 may be molded from a blend having, for example, an E-modulus of about 1000 MPa. The cock 204 may provide for venting of the valve 202, allowing fluid to be evacuated from the valve 202. On the path 223 of the cock 204, a tearaway tamper proof tab 211 may prevent any inadvertent movement of the cock 204 to prevent inadvertent activation of the access port 200. The tamper proof tab 211 may prevent the cock 204 from rotating to lock the plunger 206 of the access port 200 in the standby position. The tamper proof tab 211 may be constructed of the same material as the cock 204. The tamper proof tab 211 is removably attached to the cock 204. The cut-out 21 between the running path 223 of the cock 204 and the tamper proof tab 211 may provide for removal of the tamper proof tab 211 from the cock 204. Of course, the tamper proof tab 211 may be removably attached to the cock 204 by other methods, such as using adhesive or the like.

The cock 204 may provide four functions. First, the cock 204 may create a fluid path by connecting the administration line 140 to the container 100a, as shown in FIG. 1. The cock 204 may be hollow and may have a press-fit shaft 225 at one of its ends for engagement to the administration line 140. Second, the cock 204 may generate the force required to pierce the film 150 of the container 100a by providing the lever 226. A user's hand or finger may be positioned on the lever 226. Third, the cock 204 may act as a cam. For example, the cock 204 may activate the plunger 206 by rotating the lever 226 from a substantially horizontal position to a substantially vertical position (as shown in fig. 2B). Fourth, the cock 204 may have a washer groove 228 and snap catch 230. The gasket 208 may be annular. The gasket 208 may ensure liquid tightness of the assembly and may prevent contaminants from entering the sterile fluid path. The snap bayonet 230 may allow the components of the cock 204 to enter the valve 202 without affecting the relative degree of rotation of the cock 204.

The access port 200 is assembled after the valve 202, the plunger 206, the gasket 208, and the cock 204 may be connected. Removing the tamper proof tab 211 and rotating the cock 204 substantially ninety degrees may allow for an axial stroke of the plunger 206. After the plunger 206 is activated 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 may not be removed from the container 100 a. Additionally, the cock 204 may be locked into the valve body of the valve 202 so that rotation of the cock 204 may be prevented.

Rotation of the cock 204 may create a force in the access port 200. The force in the access port 200 may allow for one-handed operation. The access port 200 may enable the administration line 140 to be parallel to the side of the container 100a in the ready position.

Referring now to FIG. 3A, in another embodiment of the invention, the 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 is shown in a standby position. Each of the four different portions of the access port 300 will be discussed in more detail.

Referring to fig. 3B, the valve 302 can be molded from a mixture having, for example, an E-modulus of about 900MPa, the valve 302 providing six functions. First, the valve 302 may have the ability to seal the access port 300 to the film 150 of the container 100 a. The valve 302 may be surrounded by a surrounding foot 310. The peripheral foot 310 may have a thickness 311 sonically sealed to the film 150 of the container 100 a. Second, the valve 302 may allow for axial guiding 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 position the perforator 306 in a standby position and an activated position. Two cantilever beams 314a and 314b may protrude from a top 316 of the valve 302. The two cantilever beams 314a and 314b may prevent removal of the perforator 306 from the valve 302.

Referring to FIG. 3C, the two cantilever beams 314a and 314b, shown in the open position, may hold the perforator 306 in a standby position. Fourth, the valve 302 may allow for a perforator guiding system. Two slots 318a and 318b are provided to receive 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 in the valve 302. Fifth, the valve 302 may have threads 319 to guide and/or mate with the threaded housing 304. Finally, as shown in FIG. 3C, the perforator 306 may have two tabs 321, the tabs 321 positioned to secure the assembly in the activated position. Whether in the standby position or during the transition of the perforator 306 to the activated position, the two tabs 322 on the valve 302 prevent the threaded shell 304 from rotating (see fig. 3A), as shown in fig. 3D.

Referring to FIG. 3E, the perforator 306 may be molded from a mixture with an E-modulus greater than 1500MPa, for example. The perforator 306 may have at least five functions. First, the perforator 306 may pierce the film 150 of the container 100a and may form an inlet to the solution in the container 100 a. The tip 323 of the perforator 306 may have a tri-slope bevel 324. The tri-bevel 324 may puncture and/or may tear the film 150 under the peripheral foot 326 of the valve 302. Additionally, tri-slope bevel 324 may generate minimal friction.

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

Third, the perforator 306 may have axial and external beams or cantilever beams or arms 320a and 320b that lock into the slots 318a and 318b of the valve 302 and may 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 guiding flange 328, in combination with the cylindrical hollow shaft 312 in the valve 302, ensure the axial guiding and the liquid tightness of the assembly.

Fifth, the perforator 306 may have a snap 340 that may engage the threaded shell 304 with the valve 302 in an axial position that is substantially fixed but may allow some rotational freedom. Additionally, the gasket 308 may ensure liquid tightness of the assembly and may prevent any contamination from entering the sterile fluid path.

Referring to fig. 3F, 3G, and 3H, the threaded shell 304 may be molded from a mixture having, for example, an E-modulus of about 1000 MPa. The threaded shell 304 may have at least three functions. First, the threaded outer shell 304 may reduce the force required to pierce the membrane 150 of the solution container 100a by providing two threaded wings 340a and 340 b. The user's fingers and/or hands may be positioned on the threaded wings 340a and 340 b. Second, the threaded shell 304 may activate the perforator 306 during rotation by engaging built-in threads 342 in the threaded shell 304 with threads on the valve 302.

Third, the threaded shell 304 may have a crown (crown)345 removably attached to the threaded shell 304, wherein the crown 345 may provide an indication of tampering (tapping). 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 may be connected to the body of the threaded shell 304 by the frangible section 344. Initiating a tightening motion on the threaded shell 304 may tear the breakable sections 344. The rupture section 344 may provide evidence of tampering. The breakable section 344 may remain attached to the access port 300 after the crown 345 is separated from the threaded shell 304.

Thus, rotating the threaded shell 304 clockwise may tear the breakable sections 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 provided. The axial stroke of the perforator may force the perforator 306 to pierce and become embedded in the container 100 a. After the perforator 306 pierces the container 100a, the access port 300 may be locked in an activated position and retraction of the perforator 306 may not be possible.

The threaded shell 304 may lock onto the valve 302 such that rotation of the threaded shell 304 is possible but the perforator 306 and the valve 302 may not be interfered with. A force may be created in the access port 300 due to the axial stroke of the perforator 306. The force developed in the access port 300 may allow for one-handed operation during activation of the access port 300.

Referring now to fig. 4A, in another embodiment of the present invention, an access port 400 is generally illustrated. The access port 400 may be constructed from three pieces, namely, a valve 402, a perforator 404, and a gasket 406. The valve 402 may be molded from a blend having an E-modulus of about 900Mpa, for example. Additionally, the valve 402 may ensure at least five different functions. First, the valve 402 may have the ability to seal the access port 400 to the film 150 of the container 100 a. The valve 402 may have a peripheral section 408 with a thickness 409 and may allow the peripheral section 408 to be sonically sealed to the film 150 of the solution container 100 a.

Second, the valve 402 may allow for axial guiding of the perforator 404. The valve 402 may have a cylindrical hollow shaft 410 that may be surrounded by a crown 412. Third, the valve 402 may have a perforator locking system 405 in a standby position and an activated position as shown in figures 4B and 4C, respectively. On the outside of the valve 402, the external latch 416 may be designed to create a standby position and an activated position. In the activated position, the access port 400 may be locked.

Fourth, the valve 402 may create a fluid path and may connect the administration line 140 to the container 100 a. The valve 402 may have a press fit shaft 418 to engage the administration line 140. Finally, the valve 402 may have a finger pad 420, which finger pad 420 may indicate a location where a user's finger may be positioned. The finger pad 420 may concentrate the forces that may be applied around the valve 402.

The perforator 404 may be molded from a compound having an E-modulus greater than 1500MPa, for example, and the perforator 404 may provide at least six functions. First, the perforator 404 may pierce the film 150 of the container 100a to provide access to the solution in the container 100 a. 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 foot 408 of the valve 402 with minimal friction. Second, the perforator 404 may have a gasket groove 426 and a guiding cap 428. The gasket groove 426, gasket 406, and guide cap 428, in combination with the cylindrical hollow shaft 410 of the valve 402, may provide axial guidance and liquid tightness of the access port 400. Third, the perforator 404 may include a blunt hollow shaft 430 from the tip 421 through a middle 431 of the axial extension of the perforator 404. Additionally, a window 432 in the blunt hollow shaft 430 may allow solution to flow from the container 100a into the body 434 of the valve 402.

Fourth, the perforator 404 may include an integral cantilever beam 436 with a detent 438 that may cooperate with an external latch 416 designed on the valve 402. The shaft 430 of the perforator 404 may be prevented from rotating within the valve 402. In addition, the arms 442 on the inside of the perforator 404 may be designed to form the perforator 404 in the standby and activated positions 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 tamper proof tab 444 that may lock the perforator in a standby position and may prevent any inadvertent activation. The tamper proof tab 444, which is removably attached to the arm 442, may be removed by breaking the attachment between the tab 444 and the arm 442. Finally, the catch 438 and latch 416 of the perforator 404 may produce an audible notification when snapped together and/or may also prevent further withdrawal of the perforator 404. The gasket 406 may ensure liquid tightness of the assembly and/or may prevent any contamination from entering the sterile flow path.

Removal of the tab 444 may allow for axial stroke of the perforator 404. After the perforator 404 is activated, the perforator 404 may be embedded within the valve 402 such that the perforator 404 may be difficult to retract. A force may be created in the access port 400 due to the axial stroke of the perforator 404. The force in the access port 400 may provide one-handed operation when the connection is enabled and may also prevent the need to maintain an additional container.

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

Referring to fig. 5B, the valve 502 can be molded from a mixture having an E-modulus of about 900MPa, for example. The valve 502 may have four different functions. First, the valve 502 may seal the access port 500 to the film 150 of the container 100a, as shown in fig. 5D. The valve 502 may be surrounded by a surrounding foot 510, the surrounding foot 510 having a thickness 511 to sonically seal the access port 500 to the membrane 150 of the container 100 a. Second, the valve 502 may axially guide the perforator 504. Valve 502 may provide a cylindrical hollow shaft 516 having four axial and external flanges 514. The axial and outer flanges 514 may form two axial sliding slots 516. The axial and outer flanges 514 and the axial slide slots 516 are discussed in more detail below.

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

Fourth, the valve 502 may attach two housings 508. The valve 502 may have two diametrically opposed hinge axes (articulation)540 at right angles to the slot 512. The hinge axis 540 may provide an axis 546 about which the housing 508 may rotate.

Referring to FIG. 5C, the perforator 504 may be molded from a mixture with, for example, an E-modulus greater than 1500 MPA. The perforator 504 provides five functions. First, the perforator 504 may pierce the film 150 of the container 100a and may open access to the solution of the container 100 a. The tip 518 of the perforator 504 may have a tri-slope bevel 520, the tri-slope bevel 520 being designed to puncture and/or tear the film 150 under the surrounding foot 510 of the valve 502. The tri-slope bevel 520 of the tip 518 may result in minimal friction between the perforator 504 and the film 150.

Second, the perforator 504 may create a fluid path between the container 100a and another object (such as a person or a second container or the like). In addition, the perforator 504 may connect the administration line 140 to the container 100 a. The perforator 504 is hollow and has a shaft 522 that may be engaged to 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 in the valve 502 may ensure axial guiding and liquid tightness between the perforator 504 and the valve 502. In addition, the gasket 506 may ensure a liquid-tight seal between the perforator 504 and the valve 502 and may prevent contaminants from entering the fluid path from the container 100a to the administration set.

Fourth, the perforator 504 may have a landing 550, and the landing 550 may be orthogonal to the axis of the perforator 504. In addition, the perforator 504 may have two sliding grooves 552 that translate the pinching motion of the shell 502 into a force directed onto the perforator 504. Fifth, two cantilever beams 554 may mate in the slot 512 of the valve 502. The cantilever beams 554, after mating with the slots 512, may prevent rotation of the perforator 504 within the cylindrical hollow shaft 516 of the valve 502. More specifically, a detent 548 at the end of the slot 512 can lock with a latch 556 on the cantilever beam 554. The latches 556 of the cantilever beams 554 may lock the perforator 504 in the standby and activated positions in the valve 502. The tabs 549 (shown in figure 5C) lock the perforator 504 in a standby position prior to use.

Referring again to fig. 5A, the housing 508 can be molded from a mixture having an E-modulus greater than 2000MPa, for example. The housing 508 may provide five functions. First, the housing 508 may provide finger pads 558. When in use, the finger pads 558 may focus the pinching force applied by the user. Second, the housing 508 may have a hinge axis 560 for mating the housing 508 to the valve 502. The hinge shaft 560 may have two protrusions 562 that may block the position of the housing in an angled standby position, as shown in fig. 5A.

Third, the shell 508 has a beam 564 that rests into a sliding groove 552 on the platform 550 of the perforator 504. The beam 564 may translate the force applied by the user into a translational motion. More specifically, the tip 566 of the beam 564 may slide into the sliding groove 552 of the platform 550.

Fourth, a latch and catch 568 are provided within the outer shell 508 at the distal end 570 of the outer shell 508. When each shell 508 is snapped together, the detent and latch 568 may lock and produce a sound. The sound may provide an audible notification that the housing 508 is locked. Additionally, the latch and catch 568, when snapped together, may prevent reopening and/or separation of the outer shell 508. Fifth, the shells 508, when closed together, may form a cylinder around the activation perforator 504 such that the access port 500 is covered by a lid, as shown in figure 5D.

Closing the shell 508 may provide an axial stroke of the perforator 504. Separating the shell 508 or otherwise moving the shell 508 after the shell 508 is locked may not move the perforator 504. The ratio of the pivot lengths may enable the access port 500 to reduce the force required to pierce the film 150 of the container 100 a. The force in the access port 500 may increase due to the housing 508 being locked. The force in the access port 500 may provide for one-handed operation.

The present invention can provide one-handed operation and can provide audible and visible notification when the tri-slope bevel pierces the film 150 to allow the solution to flow from the container 100 a. Additionally, after engagement is achieved, the present invention may inhibit contamination by fully capping the fluid generation path to exclude contact and airborne contamination and not allowing removal of the perforator or plunger from the fluid engagement location. In addition, the present invention may reduce the amount of force required to penetrate the film of the container.

Referring now to fig. 6-12, one embodiment of an access port with a safety tab is illustrated by a piercing assembly 10, the piercing assembly 10 being connected to a solution container 100b, such as a dialysate bag. Solution container 100b, like solution container 100a, 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 solution and then sealed along the top to form a sealed fluid-filled container. The container 100b may be made of a transparent material (e.g., Clearflex)^TMMaterial) is constructed. The container 100b in one embodiment includes a medication port 120 that receives a medication additive. As illustrated, the medication port 120 in one embodiment includes an injection site protected by a plastic cap.

The container 100b also includes a flap 110 having a reinforced hanger 112 that enables the container 100b to be vertically suspended as desired. A hang port 112 is placed at the top of the container 100b so that the perforation assembly 10 extends downward to enable the solution to be gravity fed and/or to assist with aspiration when aspirating the solution.

As illustrated, the container 100b is a multi-compartment container including a first compartment 114 and a second compartment 116. Compartment 114 holds a first fluid, such as an electrolyte for peritoneal dialysis. Compartment 116 holds a second fluid, such as bicarbonate for peritoneal dialysis. When the seal 118 is ruptured or ruptured, the first fluid mixes with the second fluid to form dialysate that is delivered to the patient's peritoneal cavity. One suitable multi-compartment pouch is described in U.S. patent No. 6,663,743, assigned to the ultimate assignee of the present application, the entire contents of which are incorporated herein by reference.

The container 100b includes a valved output 30 that outputs the medical solution to the patient. The valve 30 in one embodiment has a liner constructed of, for example, the same elastomeric material as used for the compartments 114 and 116. The piercing assembly 10 is connected (e.g., snap-fit) to a port extending from the valve 30. An infusion line (such as tube 140 in fig. 1) is connected to the opposite end of the perforation assembly 10, while the opposite end of the perforation assembly 10 is connected to a subject, such as a disposable cassette, patient, other bag, or the like.

The perforation assembly 10 comprises a housing 12. Housing 12 includes a base 14, base 14 snap-fitting over a port extending from valve 30 sealed to solution container 100 b. As best seen in fig. 7-10, the bottom 14 of the housing 12 includes a plurality of individual flange sections 14a through 14 d. The individual segments may flex to snap fit over the port extending from the valve 30 of the container 100 b.

Shell 12 encloses perforator 16. Shell 12 and perforator 16 are made of any suitable medically compatible material, such as plastic that may be sterilized by gamma radiation or ethylene oxide. Specifically, suitable plastics include.

As seen in fig. 9 and 10, perforator 16 includes a threaded end 32 extending from the top of shell 12. The threaded end 32 is configured to fluidly connect to a luer or other type of fitting that is connected to a tube or hose 140 (fig. 1) of an infusion set. The threads of the threaded end 32 also engage the nut 18 (fig. 6-8), which nut 18 protects the threaded end 32 prior to use of the piercing assembly 10.

At its opposite end, perforator 16 includes beveled tip 34. The bevel angle may be any suitable angle, such as thirty to sixty degrees relative to a longitudinal axis of stem 36 of perforator 16. The angled tip 34, in one embodiment, includes a rib 38 that extends longitudinally with the tip 34 and provides rigidity to the tip 34 to penetrate the container 100 b.

A series of flanges extend radially outward from stem 36 of perforator 16. From the top, circular flange 26 extends outwardly from a top portion of stem 36 of perforator 16. Flange 26 is discussed in more detail below and is configured to be removably attached to safety tab 20. For rigidity, the plurality of gussets 40 support the flange 26. Gusset 40 serves to stabilize perforator 16 when safety tab 20 is torn away from perforator 16.

A series of locking flanges 42 are provided on the rod 36 below the flange 26. When perforator 16 is moved to the piercing position (fig. 10), locking flange 42 engages a protrusion 44 extending inwardly from the inner wall of shell 12. Although not specifically illustrated, projection 44 is tapered or rounded along its upper perimeter to enable ramped engagement with flange 42 as perforator 16 moves toward the bag piercing position. Projection 44 is substantially perpendicular to the wall of shell 12 along its lower perimeter to provide a locking engagement with flange 42 when perforator 16 is moved or snapped to its pouch piercing position.

As seen in fig. 6-10, the housing 12 includes a plurality of U-shaped cut-out flaps (cutoutflaps) 46. The cut out flap 46 may be slightly curved relative to the rest of the housing. The projections 44 are located on the inner surface of the wing 46. As the perforator 60 moves relative to the shell 12, the wings 46 flex slightly outward to allow the locking flange 42 to move past the projections 44 and eventually snap-fit between the projections 44 and/or around the projections 44. Engagement between the flange 42 and the projection 44: (i) provide tactile and/or audible feedback to the user indicating that container 100b is pierced and (ii) prevent removal of perforator 16 from container 100b after the container is pierced.

As can be seen in fig. 7, 9 and 10, a drive flange 48 is provided on the lever 36 below the locking flange 42. The member 50 is hingedly coupled at a first end to the arm 22 of the housing 12. The member 50 extends through an aperture 52 defined by the housing 12 and contacts the top surface of the drive flange 48 at its second end. And arm 22 is hingedly coupled to the top of the housing of housing 12.

Fig. 9 and 10 illustrate the piercing movement of the piercing assembly 10. Once safety tab 20 is removed, manual pressure is applied to the exterior of arm 22. As illustrated by the arrows of fig. 9, manual pressure causes the arm 22 to rotate toward the housing of the housing 12. Rotation of the arms 22 causes each member 50 to rotate toward its respective arm 22. Rotation of member 50 causes drive flange 48 and perforator 16 to move downward (toward container 100 b).

As seen in fig. 9 and 10, when perforator 16 is in a piercing position, arms 22 and members 50 are folded onto shell 12 and are substantially aligned with the shell of the shell. Perforator 16 is moved fully downward. The flanges 42 are locked between/near the projections 44. Further, the arm 22 defines a locking opening 54 at its distal end, the locking opening 54 engaging and snap-fitting onto a protrusion 56 extending from the housing 12. The friction or snap-fit engagement of the opening 54 and the protrusion 56 further serves to retain the puncturing assembly 10 in the locked position after piercing engagement and fluid communication with the container 100b is established.

A pair of sealing flanges 58 extend from stem 36 adjacent angled tip 34 and rib 38. Sealing flange 58 seals about the section of valve 30 being pierced to help form a liquid-tight seal between perforator 16 and container 100 b.

As seen in fig. 6-9, perforator 16 includes or is initially attached to removable safety or tamper proof tab 20. When safety tab 20 is connected to perforator 16, a person is prevented from rotating arm 22 and member 50 inwardly toward shell 12 and thus pushing perforator 16 downwardly with respect to shell 12 of perforation assembly 10.

Safety tab 20 includes a ring 24 that extends around a circular flange 26 of perforator 16. As discussed in more detail below in connection with fig. 11, ring 24 is connected to flange 26 by a plurality of frangible fixtures, such as eight fixtures. The diameter of ring 24 is greater than the inner diameter of hollow shell 12 so that perforator 16 cannot move within shell 12 until ring 24 of safety tab 20 is removed from flange 26. The diameter of flange 26 is less than the inner diameter of hollow shell 12 so that flange 26 of perforator 16 may move within shell 12 after ring 24 of tab 20 is removed from flange 26.

Ring 24 of safety tab 20 is also connected to handle 28, which handle 28 includes knurling, perforations, protrusions, or other types of mechanisms such that handle 28 can be intuitively perceived and easily grasped and pulled. The handle 28 is ergonomically configured to avoid slippage and provide a larger gripping area away from the housing of the housing 12. The handle 28 may be substantially vertical relative to the perforation assembly 10, substantially perpendicular relative to the assembly, or positioned at any desired angle. The operator grasps handle 28 and tears ring 24 from perforator 16 by breaking a plurality (e.g., eight) of the fixtures.

As seen in fig. 11 and 12, the ring 24 is connected to the flange 26 by a plurality of fasteners 60 (e.g., eight fasteners). The number, size and/or shape of fixtures 60 are selected so that disassembly of any particular fixture is relatively easy, while the total anti-interference force provided by all fixtures 60 is suitably large so that ring 24 of tab 20 does not inadvertently disengage from flange 26 of perforator 16.

In the illustrated embodiment, the shape of the fixation portion 60 is tetrahedral, such as a spherical tetrahedron (i.e., all sides of a triangular face have the same length). In the illustrated embodiment, one of the faces of each fixation 60 is integral with the ring 24 or attached to the ring 24, while the opposing tips of the fixation 60 make substantially point contact with the flange 26 of the perforator 16. In this manner, retainer 60 is disengaged from ring 24 of tab 20 so that the edges of flange 26 are at least relatively clean so that flange 26 of perforator 16 may move smoothly through the housing. However, it should be understood that the housing 12, ring 24, and flange 26 may be sized such that one of the faces of each fixation portion 60 is integral with the flange 26 or attached to the flange 26, while the opposite tips of the fixation portions 60 are in substantially point contact with the ring 24 of the tab 20.

As seen in fig. 12, the geometry and orientation of each fixation portion 12 provides the weakest tear strength in a direction at least substantially perpendicular to the plane of flange 26 of perforator 16 (in a direction at least substantially parallel to stem 36 of perforator 16 and shown by force arrows F and F). For example, assuming that securement 60 of tab 20 is made of polypropylene, a tear resistance of about five newtons to about ten newtons per securement 60 can be achieved with a triangular shaped micro-contact (pinpoint contact) of 0.6mm height and 0.3mm width. Assuming eight fixtures 60, the resulting total uniform interference force F is about forty to about eighty newtons. With the above configuration, the tearing force F and the interference resistance force F can be optimized.

With piercing assembly 10 installed in valve 30 and safety tab 20 removed, arms 22 may be pressed inward to cause piercer 16 to move and pierce valve 30 of solution container 100 b. The operator connects a device, such as an infusion set, to perforator 16 in a fluid-tight manner using a luer fitting by removing cap 18 and connecting the device via threads located on the top of perforator 16. Fluid flows from container 100b, through stem 36 of perforator 16, through the administration set, and into the patient or another container. In one embodiment, the different fluids within the vessel 100b are pre-mixed prior to the fluid communication described above.

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

Claims (8)

1. An access port, comprising:

a perforator comprising an end configured to pierce a medical fluid container, the perforator comprising an end portion configured to be in fluid communication with a fitting;

characterized in that the access port further comprises a shell positioned outside the perforator, the shell comprising a shell and a pair of arms (i) hingedly connected to the shell and (ii) extending angularly away from the shell towards a piercing end of the perforator, the shell further comprising members each having a first end hingedly connected to one of the arms and a second end contacting the perforator, the members being operable to push the perforator towards a medical fluid container when the arms are pushed towards the shell of the shell.

2. The access port of claim 1, comprising a safety tab removably attached to the shell, the safety tab preventing the perforator from piercing the medical fluid container.

3. The access port of claim 1, wherein the members are each configured to perform at least one of: (i) connect to a middle of one of the arms and (ii) contact a flange extending from the perforator.

4. The access port of claim 1, wherein the perforator and the shell are configured to provide at least one of: (i) audible feedback when the perforator is moved relative to the shell; (ii) tactile feedback when the perforator is moved relative to the shell; and (iii) a locking engagement when the perforator is moved to a piercing position relative to the shell.

5. The access port of claim 2, wherein the safety tab comprises a ring that initially prevents the perforator from piercing the medical fluid container.

6. The access port of claim 5, wherein the ring is connected to the perforator by a plurality of frangible fixtures.

7. The access port of claim 5, wherein the access port includes a flange extending from the perforator, the ring being connected to the flange by a plurality of frangible fixtures.

8. The access port of claim 5, wherein the safety tab includes a handle connected to the ring, the handle configured to be manually grasped and pulled.