Fluid container with access port and safety cap

[0001] This application is a partial continuation of US Patent Application No. 11/139 244, filed May 27, 2005 and entitled "Access Port with Safety Tab and Fluid Container Employing Same" ("Access connection with security plate and fluid container using it") , which is a partial continuation of US Patent Application No. 10/277 432, filed October 22, 2002 and entitled "Formed, Filled, Seaied Solution Container, Port And Method For Establishing Flow Between The Container And An Administration Set "." BACKGROUND OF THE INVENTION [0002] The present invention generally relates to a container, access port and method of establishing flow between the container and the administration set. The access connection establishes fluid flow from the container to the appropriate administration set. More specifically, a valve or base has been developed that is sealed to the container. A perforator or stem in the valve pierces the container and provides access to the solution in the container. The security cap on the access connection protects the access connection and helps maintain integrity and control of the connection.

[0003] Containers for administering medical solutions are well known. Such containers are usually made of flexible film, which is folded and sealed together along the peripheral side edges. In addition, these containers usually have a flap and outlet. The containers in addition usually have a device for piercing the outlet and establishing fluid communication between the device and the solution inside the container. The solution can then be drained from the device and introduced into the administration set and / or into the patient's body.

[0004] The sterility of the medical solution to be administered to the patient is very important. However, handling a container with a medical solution may pose a risk of contamination. The risk of contamination may increase in emergency situations where rapid handling of various components can cause bacteria or other pathogens to enter the container. For example, the user may inadvertently touch and / or contaminate the sterile inlet or outlet end surface. Contamination may then enter the contents of the container. [0005] In addition, containers for the administration of medical solutions are usually flexible. Therefore, creating an aseptic connection with a flexible container for aseptic collection of content can be difficult. For example, Renewed Patent No. RE 29 656 to Chittenden et al. Discloses an additive transfer assembly having a tubular element that is sealed to a container with a solution. This assembly includes a needle that pierces the plug of the solution container. The creation of a liquid tight and leaking connection through a flexible container using traditional medical connectors, such as for example needles or piercing needles, is difficult.

[0006] In addition, the flexible delivery connections are securely assembled with the flexible container. However, connections for the administration of known flexible solution containers are often the weakest part of the container. Therefore, the proper operation of some medical solutions may be prevented,

EP 2 103 295 B1 which are sensitive to the effects of oxygen and / or other penetrating gases. In addition, pre-formed delivery ports are potentially leakage sites and are potential contamination entry points.

[0007] US 2005/0283132 discloses an access connection for a medical container that includes a jacket, a perforator and a protective plate connected to the perforator. The protective plate is removed manually to allow perforation of the medical container.

[0008] Other means for establishing a fluid connection between the container and the administration set are also known. As a rule, known access connections require two-handed operation and do not provide audible or visual feedback when the access connection is completely engaged. In addition, many of the known access connections do not substantially protect against touch and airborne contaminations.

[0009] There is therefore a need for a shaped, filled, sealed solution container with an access connection and a method for establishing flow between the container and the administration set, there is also a need for a container with a medical solution and an access connection with increased ease of access. Furthermore, there is a need for a solution container and a secured, covered access connection with a liquid tight seal to prevent leakage, minimize the risk of air and contact contamination, and minimize oxygen and other gas permeation. Additional features and advantages described herein will become apparent from the following detailed description and figures.

SUMMARY OF THE INVENTION [0010] According to the present invention, an access connection has been developed according to claim 1 and a medical fluid container assembly as claimed in claim 1. 18. The access connection includes a jacket adapted to be connected to a fluid container, a piercing device located inside the jacket and able to move axially therein, which piercing device comprises a first end configured for piercing a medical fluid container and a second end configured for connection to a fluid transfer device . The access connector also includes a removable safety cap configured to fit at the other end, which cap is adapted to resist the axial displacement of the piercer when connected to the other end. At least one arm is also pivotally connected to the jacket and mechanically coupled to the piercer, whereby the arm deflection displaces the piercer axially relative to the jacket. In some embodiments, the safety cap further includes an annular projection configured to fit within the jacket to prevent rotation of the jacket relative to the plane of the medical fluid container, wherein the fit of the safety cap at the other end is an interference fit between the annular projection and the piercing and between the annular projection and a coat. The access connection may further include an O-ring sealing washer around the puncture to prevent fluid leaking after puncturing with the medical fluid container.

[0011] According to the present invention, the access connection comprises a fluid transfer device, which is a fluid conduit, and further includes a jacket located outside the piercer, which jacket includes a body and a pair of arms articulated with the body and extending diagonally from

ΕΡ 2 103 295 BI of the body towards the sharp end of the piercing, wherein the jacket further includes elements each of which has a first end articulated to one of the arms and a second end in contact with the piercing, these effects pushing the piercing towards the fluid container medical, when the arms are pushed toward the jacket body. The cap is configured to cover the connecting end of the piercer and to prevent piercing of the medical fluid container with the piercer until the cap is removed. In some embodiments, the cap further includes an annular projection that fits snugly inside the jacket.

[0012] A fnny embodiment provides a medical fluid container assembly. The medical fluid container assembly includes at least one flexible film forming a liquid tight container, an access connection with a jacket configured to connect it to the container, a piercer located inside the jacket and able to move axially therein, the piercer comprising a first end configured for piercing a container with medical fluid and the other end configured for connection to a fluid transfer device, and a removable protective cap configured to cover one of the ends of the access port, which cap is adapted to prevent axial displacement of the piercer when connected to the other end. The assembly also includes at least one arm pivotally connected to the jacket and mechanically coupled to the piercer, whereby the arm deflection displaces the piercer axially relative to the jacket. In some embodiments, the securing cap further includes an annular projection configured to fit within the casing to prevent rotation of the casing relative to the medical fluid container plane, wherein the fit of the securing cap at the access port is an interference fit between the annular projection and the piercing or between the annular projection and a coat. There are also possible embodiments of the invention, of which only a few are described in the figures and in the detailed description below.

BRIEF DESCRIPTION OF THE FIGURES [0013] Fig. 1 is a perspective view that illustrates one embodiment of a medical fluid container, valve and access port;

[0014] Fig. 2 is another perspective view that illustrates the fluid container, valve and access connection of Fig. 1;

[0015] Fig. 3 is a side view that illustrates the access connection of Figs. 1 and 2;

[0016] Fig. 4 is a cross-sectional side view that illustrates the access connection of Figs. 1-3 in a non-punctured position; and [0017] Fig. 5 is a cross-sectional side view that illustrates the access connection of Figs. 1-3 in the puncture position.

DETAILED DESCRIPTION [0018] Embodiments may be provided for single-handed operation and may provide audible and visual notification of piercing the film in a fluid bag to allow solution to flow from the container. In addition, embodiments may block contaminants completely covering the fluid supply path to exclude the risk of contact and air contamination, and prevent the piercing device or mandrel from withdrawing from the connection position

ΕΡ 2 103 295 Bl flow after obtaining such coupling. Furthermore, embodiments may reduce the amount of force required to pierce the container film.

[0019] Referring now to Fig. 1, one embodiment of the access connection is illustrated by a piercing assembly 10 that is connected to a solution container 100, such as a dialysate bag. The solution container 100 can be made by folding and sealing the film along its side edges. The folded film can then be filled with a medical solution and then sealed along the top edge to form a sealed container filled with liquid. The container 100 may be made of a transparent material, e.g., ClearFlex ™ multi-layer material. In one embodiment, the container 100 includes a drug nipple 120 that is adapted to receive a medicinal additive. As shown, the pipe stub 120 in one embodiment includes an insertion point secured with a plastic cap.

[0020] The container 100 also includes a flap 110 with a reinforced hanger 112, which allows the container to be hung vertically if necessary. Hanger 112 is located at the top of container 100 so that the piercing assembly 10 extends downward enabling gravity feeding of the solution and / or assisting the pump to pump the solution.

[0021] As shown, the container 100 is a multi-chamber container comprising a first chamber 114 and a second chamber 116. In the chamber 114 there is a first fluid, such as the glucose-electrolyte component of the solution for peritoneal dialysis or parenteral nutrition. The chamber 116 contains a second fluid, such as a component of the peritoneal dialysis solution, being a bicarbonate buffer, or an amino acid component of the solution for parenteral nutrition. When the seal 118 is broken or broken, the first and second fluids mix with each other to form a finished medical solution, i.e., for example, dialysate introduced into the patient's peritoneal cavity or a solution for parenteral nutrition that can be administered intravenously. One suitable multi-chamber bag is described in US Patent No. 6,663,743 assigned to the holder of this application.

[0022] The container 100 includes an outlet with a valve 30 through which the medical solution is introduced into the patient's body. In one embodiment, the valve 30 has an insert made of an elastomeric material, such as, for example, the material used for chambers 114 and 116. The piercing assembly 10 is connected, e.g., snap-fit, at the port extending from the valve 30. A delivery tube, such as a tube, is connected to the opposite end of the piercing assembly 10, which in turn is connected to an object, such as a disposable cassette, patient, other bag, etc.

[0023] The piercing assembly 10 comprises a jacket 12. The jacket 12 includes a bottom portion 14 that snaps over the port extending from the valve 30 sealed to the solution container 100. As best shown in Figs. 2 to 5, the lower portion 14 of the jacket 12 includes a plurality of separate flange members 14a to 14d. The separate members may bend to snap over the port extending from the valve 30 of the container 100.

[0024] The jacket 12 covers the piercer 16. The jacket 12 and the piercer 16 are made of any suitable medically compatible material, for example any plastic, which can be sterilized by gamma radiation, ethylene oxide or steam. In particular,

ΕΡ 2 103 295 BI suitable materials include polypropylene (PP), polycarbonate (PC), polystyrene (PS), polyoxymethylene (POM), ABS terpolymer (acrylonitrile / butadiene / styrene) and many other medically acceptable plastics.

[0025] As shown in Figs. 4 and 5, the puncture 16 includes a threaded end 32 that extends beyond the top of the jacket 12. The threaded end 32 is configured for fluid connection with a type i connector or other type of connector, which in turn is connected to the feeding set tube or hose. The threaded end 32 is further interlocked with a female threaded cap 18 (Figs. 1-3) that secures the threaded end 32 against use of the piercing assembly 10.

[0026] At its other end, the piercer 16 comprises a beveled tip 34. The angle of the shear may have a corresponding value, for example, thirty to sixty degrees relative to the longitudinal axis of the stem 36 of the piercer 16. The oblique tip 34 in one embodiment includes ribs 38 that extend longitudinally with the tip 34, and when placed in the slots formed inside the valve 30, are means for blocking the rotation of the piercer 16 when the cap 18 or luer connector of the administration set is screwed and unscrewed.

[0027] A series of collars extends radially outwardly from the shank 36 of the piercer 16. Starting from the top, outside from the top of the shank 16 of the piercer 16, a round flange 26 extends. To ensure rigidity, the flange 26 is supported by a plurality of 4 0 wedges. The wedges 40 perform the function of stabilizing the flange 26 when the pierce 16 sinks.

[0028] On the shank 36, below the flange 26, a series of guide flanges 42 are present. The guide flanges 42 are intended to facilitate the assembly procedure of both components 50 through the gap 52 when the piercer 16 is positioned inside the jacket 12. Although not shown in detail, protrusions 44 extending inwardly from the inner wall of the jacket 12 (fig. 5) are used. These projections 44 are tapered conically or rounded along their upper periphery to allow stepped engagement with the lead collar 48 when the piercer 16 is moved toward the piercing position of the bag. The projections 44 are substantially perpendicular to the wall of the jacket 12 along their lower periphery to provide locking engagement with the lead collar 48 after displacement or jumping of the piercer 16 into its piercing position of the bag.

[0029] As shown in Figs. 1-5, the cladding 12 includes a plurality of U-shaped blanking flaps 46. The blanking flaps 46 may slightly bend relative to the rest of the cladding 12. The projections 44 are on the inner surface of the flaps 46. As the piercer moves With respect to the jacket 12, the flaps 46 slightly bend outwardly to allow the flange 48 to pass past the projections 44, and finally its snap-fit ​​snap between the projections 44 and / or around them. The coupling between the lead collar 48 and the projections 44 prevents removal of the piercer 16 from the container 100 after piercing the container. Such engagement may further provide a perceived tactile and / or auditory feedback to the user which indicates that the container 100 has been punctured.

[0030] As shown in Figs. 2, 4 and 5, the lead collar 48 is located on the stem 36 below the guide flanges 42. The elements 50 are articulated at the first ends to the jacket arms 22

12. The elements 50 pass through the slits 52 defined by the jacket 12 and are in contact with their other ends with the upper surface of the flange 48. In turn, the arms 22 are articulated with the upper part of the jacket body 12.

[0031] Figs. 4 and 5 show the piercing movement of the piercing assembly 10. After removing the integrated cap 18, manual pressure is applied to the outer parts of the arms 22. As shown by arrows A in Fig. 4, manual pressure causes the arms 22 to rotate toward the jacket body 12. The rotation of the arms 22 causes each of the elements 50 to rotate towards the corresponding arm 22. The rotation of the elements 50 causes the flange 48 and the piercer 16 to move downwards (towards the container 100).

[0032] As shown in Figs. 4 and 5, when the piercer 16 is in the piercing position, the arms 22 and members 50 are folded along the jacket 12 and are substantially aligned with the jacket body 12. The piercer 16 is completely displaced downwards. Flange 48 is locked between or around projections 44. In addition, the arms 22 define at their distal ends locking holes 54 that engage and snap on protrusions 56 extending from the jacket 12. The interference or snap engagement of holes 54 with protrusions 56: (i) serves to further hold the piercing assembly 10 in the locked position after forming the piercing engagement and fluid connection with the container 100, (ii) provides a tactile and / or audibly feedback signal to the user which indicates that the container 100 is pierced, and (iii) prevents removal of the piercer 16 from the container 100 after piercing the container.

[0033] A pair of sealing flanges 58 extends from the stem 36, near the beveled tip 34 and the ribs 38. The sealing flanges 58 define a groove in which a suitable seal is mounted (not shown). The seal creates a liquid-tight and bacterial-tight seal between puncture 16 and valve 30. Such a seal also helps ensure sterile delivery of the contents of the container 100 via the puncture assembly 10.

[0034] As shown in Figs. 1-4, the puncture device 16 is initially attached to the removable integrated safety cap 18. When the cap 18 is screwed onto the puncture tool 16, it stops axial displacement within the jacket 12 that would pierce the film, even if it is to the shoulders 22, an inward force is applied. Preferably, annular bead 18a and downwardly extending projection 18b of cap 18 also adhere closely to jacket 12.

[0035] The cap also preferably includes a plurality of outer ribs or gripping flanges 18c. 18c ribs increase the stability of the attachment. These elements make it easier for the user to grasp and remove the attachment. The adapter 18 is further preferably connected to the non-penetrating end of the piercer by means of internal thread turns 18d, engaged with thread turns 32 onto the piercer u. In a preferred embodiment, threads 32 and 18d may be threads of a female and male luer connector.

[0036] As shown better in Fig. 4, the annular projection 18b fits between the jacket 12 and the piercer 16. The width of the annular projection structure can be chosen to fit closely with the jacket, piercer or both. At least one of these adjustments is tight enough to cause friction or slight negative play when placing the cap on the access terminal or when removing the cap from the access terminal. In one embodiment, the fit between the annular projection 18a of the attachment and the upper portion of the piercer 16 is tighter than between the annular projection 18a and the upper portion of the jacket 12. This helps to prevent displacement of the piercer and helps ensure the sterility of the connector at the upper end of the piercer. This tight or interference fit also prevents the jacket from rotating around the piercer,

EP 2 103 295 B1 as long as the cap remains in place at the access connection. The negative clearance between the puncture and the cap ring is preferably greater than the negative clearance between the cap ring and the mantle. [0037] The operator connects the device, such as the feeding set, to the luer connector with the piercer 16 in a fluid manner by removing the cap 18 and connecting the device via a thread 32 located at the top of the piercer 16. After mounting the piercing assembly 10 in the valve 30 and removing the cap 18, the arms 22 can then be pressed inward to displace the piercer 16 and pierce the solution container 100 with it. The fluid flows from the container 100 through the shank 36 of the piercer 16, through the administration set, and flows into the patient's body and into another container. In one embodiment, the various fluids in the container 100 are premixed prior to making the above fluid connection.

[0038] It should be understood that various changes and modifications to the currently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the present invention which is included in the appended claims.