Access port with safety tab and fluid container employing same

[0001] This application claims priority to US Patent Application No. 10/277 432, filed October 22, 2002, entitled "Molded, filled, sealed fluid container, port, and method of establishing flow between the container and the delivery set".

Background of the invention [0002] The present invention generally relates to a container and an access port for establishing flow between the container and the delivery set. This access port may establish fluid flow from the container to the appropriate delivery set. More specifically, a valve or base sealing the container is used. A perforator or plug in the valve pierces the container and provides access to the solution in the container.

[0003] Containers for administering medical solutions are well known. Typically, such containers are made of flexible film and are sealed along the peripheral side edges. Furthermore, the containers typically have an inlet and an outlet. The containers typically have a device for piercing the outlet opening and establishing fluid communication between the device and the solution within the container. The solution can then be led from the device to the administration set and / or ub into the patient's body. [0004] Maintaining the sterility of the medical solution for administration to the patient is extremely important. However, handling a container with a medical solution may pose a risk of contamination. The risk of contamination may increase in emergency situations, when rapid handling of various components may result in the introduction of bacteria or other pathogens into the container. For example, the user may accidentally touch and / or contaminate the sterile end surface of the inlet or outlet opening. Contamination can then be transferred to the contents of the container.

[0005] Furthermore, containers for administering medical solutions are typically flexible. In this connection, sterile connection to a flexible container for discharging its contents in a sterile manner can be difficult. For example, US Patent No. 29,656 to Chittenden et al. Discloses an additional transfer unit having a tubular member that is sealed to a solution container. This unit contains a needle that pierces the stopper of the container with the solution. Achieving a fluid-tight and leak-proof connection through a flexible container using traditional medical connectors, such as needles or piercing spikes, is difficult.

[0006] Furthermore, the feeding ports are stably connected to the flexible container. Nevertheless, the feeding ports of known flexible fluid containers are often the weakest point of the container. Therefore, some medical solutions that are sensitive to oxygen and / or other permeating gases may be destroyed. Furthermore, pre-formed feeding ports are potential leakage points and are potential points for contaminants to enter.

[0007] Other means for establishing fluid communication between the container and the delivery set are also known. Generally, known access ports require a two-handed access port and do not provide an audible or visual indication when the access port is fully coupled. Moreover, many known access ports generally do not protect against touch and airborne pollution.

[0008] There is therefore a need for a molded, filled and sealed solution container with an access port, as well as for a method for establishing flow between the container and the delivery set. Therefore, a medical solution container having an improved inlet and outlet port is needed to reduce the likelihood of contamination during storage and / or use. What's more, you need a container for a medical solution and an access port with improved handling. In addition, a solution container and access port with a fluid-sealed closure is needed to avoid leakage, minimize contact and / or airborne contamination, as well as minimize oxygen and other gases.

[0009] WO 2004/037337 discloses an access part to a flexible medical container. [001Óf Document WO 2006/130378 discloses an access port comprising a shell, a perforator located inside the shell, having a piercing end for a medical fluid container, and a securing tab connected to the perforator to prevent the piercing of the container until it is removed.

Summary of the Invention [0011] According to the present invention, an access port according to claim 1 and a medical fluid container assembly according to claim 15 are provided.

[0012] The present invention relates to a molded, filled, sealed solution container with an access port for establishing a fluid connection between the container and the delivery set. More specifically, the port is sealed against the container and has a perforator to pierce the container. The fluid in the container is discharged from the container through the port into the feeding line. The feed rope continues this fluid to the feed assembly.

[0013] The port may have a valve and has a perforator. The valve may include a peripheral sealing flange or ring that may allow sealing against the container. The valve may define a cylindrical opening that can receive and slidably engage the perforator or mandrel. The cylindrical opening can guide a perforator or mandrel to pierce the container and open access to the solution contained therein. The perforator or mandrel may have a hollow shaft that includes a three-step chamfer at one end. The cylindrical opening can guide a perforator or mandrel to pierce the container and open access to the solution it contains. The perforator or mandrel may have a hollow shaft that has a three-stage bevel at the end facing the container film. This three-stage chamfer of the perforator or mandrel pierces and breaks the stretched container film below the valve sealing flange.

[0014] The present invention may relate to one-handed operation and may provide an audible and visible notification when a three-stage shear pierced the film to allow solution to flow. Furthermore, the present invention can completely cover the fluid generation path to exclude contaminants resulting from touching and airborne contaminants. The present invention may furthermore allow limiting the amount of force required to pierce the container film. In addition, the perforator or mandrel of the present invention need not be removed from the fluid engaging position after achieving this engaging.

[0015] In one preferred embodiment, an access port is used that allows access to containers having a solution inside, such as a plastic bag having a sterile medical fluid inside. This container can be manufactured in a mold, filled and subjected to a sealing operation, and can also be made of ClearfIexTM material, for example. Such containers

For example, EP 1 883 386 Β1 may contain intraperitoneal dialysis solution used in continuous renal replacement therapy ("CRRT"). For example, the access port establishes fluid flow from the containers to the appropriate delivery set.

[0016] This access port includes: (i) a perforation assembly and (ii) a valve. The valve is sealed to the container. The valve may include a peripheral sealing flange or ring that allows e.g. ultrasonic sealing to the container foil. The valve adopts and slidably couples the perforation assembly. This perforation assembly includes a perforator and a shell. The perforator moves inside the shell of the perforation assembly to pierce the container and open access to the solution contained therein.

[0017] The perforator is a hollow stem which includes a bevel cut at the end facing the container. This oblique bevel of the perforator pierces and breaks the container wall contained in the valve.

[0018] The access port enables one-hand operation and provides audible and visual notification when an oblique cut has pierced the container to allow solution to flow. This access port completely covers the flow generation path to exclude contamination by touch and from air. The access port limits the amount of force necessary to pierce the container and prevents the perforator from being removed from the fluid coupling position when such coupling is achieved. [0019] This access port works with a medical fluid container containing a valve sealed to the container wall. The access port contains a shell. The shell is attached to the container valve. More specifically, the shell includes a bottom portion that is snap-fitted onto a valve sealed to the solution container.

[0020] The shell encloses a perforator inside. This perforator extends outwardly from the top of the shell and includes a threaded end that is initially secured with a threaded cap. The perforator also includes a removable tab to protect or protect against tampering. When this tab is connected to the perforator, the operator cannot push the rotational arms of the shell inward, which action pushes the perforator downward relative to the shell of the access port. In the case of an access port installed in the valve and after removing the securing tab, the arms can be pressed inwards to cause the perforator to move and pierce the valve of the container with the solution through it. The operator can then connect a device such as a feeding set with a Luer connector to the perforator in a fluid tight manner by removing the cap and connecting the device via a thread located at the top of the perforator.

[0021] The securing tab comprises a ring that extends around a circular collar that extends radially outward from the hollow shaft of the perforator. This ring is connected to the flange at a plurality of, for example, eight, breakaway points. The locking tab ring is also connected to the handle. The operator grips the handle and tears the ring away from the circular flange by breaking eight fastening points. The flange is smaller than the inside diameter of the hollow shaft, and thus the flange and the associated perforator may move within the shell after removing the ring and handle from the flange.

[0022] In one embodiment, the container has a film, port and tab. The foil is folded, designating sides that are tightly connected and define the interior. The port defines an outlet opening through which fluid communication with the interior is established. The tongue is attached to the port, and this tongue defines the establishment of fluid communication with the interior.

EP 1 883 386 Β1 [0023] The access port comprises: (i) a shell; (ii) a perforator located inside the shell, said perforator comprising an end configured to pierce a container with medical fluid; and (iii) a securing tab connected to the perforator, said securing tab preventing a perforation through the medical fluid container perforator, and the securing tab can be removed manually to allow a perforation through the medical fluid container.

[0024] In one embodiment: (i) the shell may include a portion configured to be attached to a valve sealed to the container; (ii) if the end of the perforator is the first end, the perforator may include a second end configured to connect to the fluid transfer tube; and (iii) the security cap may be located at the other end.

[0025] The securing tab may include a ring that initially prevents perforation through the fluid container. The ring can attach to the perforator via numerous pull-off attachments. The geometry of each attachment can be configured in such a way that the tensile strength caused by the attachment is the least in a direction at least substantially parallel to the perforator.

[0026] Also in one embodiment, the collar may extend from the perforator, the ring being connected to the collar via a plurality of tear-off attachments. In this case, the geometry of each attachment can be configured such that the tensile strength caused by the attachment is the least in a direction at least substantially perpendicular to the collar. The flange may be dimensioned so that it fits into the shell, and the ring connected to the flange is dimensioned so that it does not fit into the shell. The securing tab may include a handle connected to the ring, the handle being configured to be manually gripped and pulled.

[0027] In one embodiment, the securing tab comprises a plurality of tear-off attachments, these attachments collectively providing a sufficiently high tamper resistance while individually providing a correspondingly low removal force.

[0028] In this embodiment, the container assembly may be provided to the customer in an unassembled state in which the access port is disconnected from the container. The container may contain a medical fluid selected from the group consisting of: dialysate and saline. At least one of the fixings may: (i) have a tetrahedron shape; (ii) be configured to narrow towards a point contact break; (iii) connect the securing tab to the perforator, said securing tab against the shell, preventing the perforation of the film; and (1v) provide a portion of all violation strength.

[0029] In another embodiment, the shell comprises a body and a pair of arms (i) articulated with the body; and (ii) extending angularly from the body towards the piercing end of the perforator, the shell further comprising members, each of which has a first end articulated to one of the arms and a second end abutting against the perforator, said members pushing the perforator towards container with medical fluid when the arms are pushed toward the shell body.

[0030] In this embodiment, each of the members is configured to at least one of: (i) connecting the central portion of one of the arms, and (ii) abutting against the collar extending from the perforator. The perforator and shell may be configured to provide at least one of: (i) an audible feedback when the perforator is displaced from the shell; (ii) tactile feedback when the perforator is displaced from the shell; and also (iii)

EP 1 883 386 Β1 blocked engagement after moving the perforator to the piercing position relative to the shell.

[0031] Therefore, an advantage of the present invention is to provide a molded, filled, sealed solution container and a port for establishing a flow between this container and the delivery set that can be operated with only one hand.

[0032] A further advantage of the present invention is the provision of a molded, filled, sealed solution container and a port for establishing flow between the container and the delivery set, providing audible notification when the access port is fully coupled.

[0033] Another advantage of the present invention is the provision of a molded, filled, sealed solution container and a port for establishing flow between the container and the delivery set, providing visual notification when the access port is fully coupled.

[0034] A further advantage of the present invention is the provision of a molded, filled, sealed solution container and a port for establishing flow between the container and the delivery set, in which the access port excludes contamination due to touch and originating from air.

[0035] Another advantage of the present invention is the provision of a molded, filled, sealed solution container and a port for establishing flow between the container and the delivery set, in which the access port provides the structure with the run mode, as well as in which the arrangement of the fingers and / or the user's hand is simple.

[0036] A further advantage of the present invention is the provision of a molded, filled, sealed solution container and a port for establishing flow between the container and the delivery set in which the access port reduces the force necessary to access the container.

[0037] Another advantage of the present invention is the provision of a molded, filled, sealed solution container and a port for establishing flow between the container and the delivery set in which the perforator may not be removed from the container.

[0038] Another one benefit of the present invention is the provision of a molded, filled, sealed solution container and a port for establishing flow between the container and the delivery set in which the access port reduces the force necessary to pierce the container.

[0039] Another advantage of the present invention is the provision of a molded, filled, sealed solution container and a port for establishing flow between the container and the delivery set, in which the access port allows selection of various raw materials for the perforator and valve.

[0040] Another advantage of the present invention is the provision of an access port suitable for connection to a medical fluid bag, the access port having a securing tab that prevents unintentional puncture of the pouch until it is removed, after which the pouch can be pierced .

EP 1 883 386 Β1 [0041] Another advantage of the present invention is to provide a visual indication of whether the medical fluid bag can or cannot be punctured through the access port.

[0042] Furthermore, the benefit of the present invention is to provide an access port with a securing tab in which the tab provides effective protection against unintentional puncture of the pouch, and yet is relatively easy to remove.

[0043] Additional features and benefits of the present invention have been described and will become apparent from the detailed description of the preferred embodiments as well as from the drawing.

Brief Description of the Figures [0044] Fig. 1 illustrates a perspective view of a container with an access port in one embodiment of the present invention.

[0045] Fig. 2 is a perspective view of one embodiment of a medical fluid container, valve and access port with a securing tab in accordance with the present invention.

[0046] Fig. 3 is another perspective view of one embodiment of the medical fluid container, valve and access port with the securing tab of Fig. 2.

[0047] Fig. 4 is a side elevational view of the access port with the security tab according to Figs. 2 and 3.

[0048] Fig. 5 is a cross-sectional side view of the access port with the securing tab according to Figs. 2, 3 and 4 in a non-piercing position.

[0049] Fig. 6 is a cross-sectional side view of the access port with the securing tab according to Figs. 2, 3 and 4 in the piercing position.

[0050] Fig. 7 is a horizontal view showing the multiple tear-off attachments of the access port security tab according to Figs. 2 to 6.

[0051] Fig. 8 is a perspective view of one embodiment of the breakaway fasteners of Fig. 7.

Detailed description of the invention [0052] The present invention generally relates to a container with an access port for establishing flow between the container and the delivery set. This port may be sealed to the container and may pierce the container to provide access to the solution contained in the container. The solution can be discharged from the container into the port, wherein the line connecting the port to the delivery kit can also discharge the solution into the delivery kit.

[0053] Referring now to the figures, where like reference numerals refer to like parts, Fig. 1 illustrates container 100a. This container 100a can be constructed by folding the film and sealing it along the sides. The folded film can 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 made of transparent material, such as, for example, Clearfiex. TM. Container 100a may contain solutions such as, for example, intraperitoneal dialysis solution. The container 100a may have an inlet 120 for receiving a medicinal additive. The inlet 120 may have an injection point secured with a plastic cap.

EP 1 883 386 Β1 [0054] The container 100a may further have an outlet opening 130 for delivering the medical solution to the patient's body. Outlet 130 may have an insert made of an elastomeric material, such as, for example, film 150, inserted between the end surface of outlet opening 130 and access port 160. Outlet film 150 may be coupled by access point 160 to establish a fluid connection between access port 160 and container 100a. Furthermore, the delivery line 140 can connect the container 100a to an object such as a patient's body, another pouch or the like. The fluid path can be established by connecting the delivery line 140 to the container 100a and the object. The feed line 140 can be connected to the container WOa via access port 160.

[0055] Figs. 2 to 8 show one embodiment of an access port with a security tab, illustrated by a perforation assembly 10 which is connected to a container 100b, such as a dialysate bag. The container 100b with the solution, like container 100a, can be made by folding the film and sealing it along the sides. The folded film can then be filled with a medical solution and then sealed along the top to obtain a sealed, fluid-filled container. The 10Ob container may be made of a transparent material, for example Clearfiex ™. Container 100b, in one embodiment, includes port 120 for drugs that receives the medicated additive. As illustrated, port 120 for the faeces in one embodiment includes an injection point secured with a plastic cap.

[0056] The container 100b also includes a flap 110 with a reinforced hanging eye 112, which allows the container 100b to be hung vertically if needed. The hanging eye 112 is located at the top of the container 100b, whereby the perforation assembly extends downwards, enabling gravity feeding of the solution and / or assisting of the pump during pumping of the solution. [0057] As illustrated, the container 100b is a multi-compartment container, comprising a first compartment 114 and a second compartment 116. In the compartment 114, a first fluid, such as electrolyte used for intraperitoneal dialysis, is stored. Compartment 116 houses a second fluid, such as bicarbonate, used for intraperitoneal dialysis. When the seal closure 118 is broken or broken, the first and second fluids are mixed together to form a dialysate that is delivered to the patient's peritoneal cavity. One of the respective multi-compartment containers is described in US Patent 6,663,743, to which rights have been transferred to the final owner of the present application.

[0058] The container 100b includes an outlet 30 provided with a valve that releases the medical solution into the patient's body. In one embodiment, the valve 30 has an insert made of an elastomeric material, such as, for example, the same material used for compartments 114 and 116. The perforation assembly 10 engages, e.g., with a snap connection to a port extending from the valve 30. A feed line, such as tube 140 in Fig. 1, is connected to the opposite end of the perforation assembly 10, which is in turn connected to an object, such as a removable disposable cassette, patient body, other pouch, etc. [0059] The perforation assembly 10 comprises a shell 12. The shell 12 comprises a bottom part 14 which it is snap-fitted on the port extending from the valve 30 sealed to the solution container 100b. As best can be seen in Fig. 3 to 6, the lower portion 14 of the shell 12 includes a plurality of separate flange sections 14a to 14d, wherein the individual sections may bend to snap close at the port extending from the container valve 30b.

EP 1 883 386 Β1 [0060] The shell 12 encloses the perforator 16 inside. The shell 12 and the perforator 16 are made of any suitable medically compatible material, such as any plastic, which can be sterilized by gamma radiation or ethylene oxide.

[0061] As can be seen in Figs. 5 and 6, the perforator 16 includes a threaded end 32 that extends outwardly from the top of the shell 12. The threaded end 32 is configured to fluidly connect a Luer connector or other type of connector which rail connects with tube or hose 140 (Fig. 1) of the feeding set. The thread of the threaded end 32 is also engaged with the female threaded cap 18 (Fig. 2 to 4), which secures the threaded end 32 against the use of the perforation assembly 10. [0062] At its opposite end, the perforator 16 includes a beveled end 34. The angle of the bevel may be any suitable angle such as thirty to sixty degrees relative to the longitudinal axis of the perforator shaft 36 16. The oblique tip 34 in one embodiment includes ribs 38 that extend longitudinally with the tip 34.

[0063] A series of flanges extends radially outwardly from the perforator shank 36. Beginning at the apex, the circular flange 26 extends outward from the apical portion of the perforator shank 36. The flange 26 is discussed in more detail below and is configured to be attached to the removable securing tab. 20. To achieve rigidity, the flange 26 is supported by a plurality of brackets 40. The brackets 40 operate to stabilize the perforator 16 when the securing tab 20 is pulled away from the perforator 16.

[0064] A number of locking flanges 42 are provided on the stem 36 below the flange 26. These locking flanges 42 engage projections 44 extending inwardly from the inner wall of the shell 12 when the perforator 16 is moved to the piercing position (Fig. 10). Although not illustrated in detail, the protrusions 44 are bevelled or rounded at their upper rim to allow for stepped engagement with the flanges 42 when the perforator 16 is moved towards the piercing position of the pouch. The protrusions 44 are substantially perpendicular to the wall of the shell 12 along its lower rim to provide locking engagement with the flanges 42 when the perforator 16 has been displaced or latched in its piercing position of the pouch.

[0065] As can be seen in Figs. 2 to 6, the shell 12 includes a plurality of U-shaped cut-out tabs 46. The cut-out tabs 46 may bend slightly relative to the rest of the shell. The projections 44 are located on the inner surface of the flaps 46. When the perforator 60 is displaced relative to the shell 12, the flaps 46 bend slightly outwards to allow the locking flanges 42 to move past the projections 44 and finally to snap between and / or around the projections 44. The coupling between the flanges 42 and the projections 44: (i) provides tactile and / or audible feedback to the user that the container 100b has been pierced, and (ii) excludes removal of the perforator 16 from the container 100b after piercing the container.

[0066] As can be seen in Figs. 3, 5 and 6, a drive flange 48 is provided on the shaft 36 below the locking flanges 42. The members 50 are articulated at the first ends of the arms 22 of the shell 12. The members 50 extend through holes 52 defined by the shell 12 and come into contact with the upper surface of the drive flange 48 at their other ends. The arms 22 are in turn articulated at the top of the shell body 12.

[0067] Figs. 5 and 6 illustrate the punching movement of the perforation assembly 10. When the securing tab 20 is removed, a manual pressure is applied to the outside of the arms 22. As illustrated

EP 1 883 386 Β1 by means of the arrows in Fig. 9, manual pressure causes the arms 22 to rotate towards the shell body 12. Rotation of the arms 22 causes each member 50 to rotate towards its respective arm 22. Rotation of the members 50 causes the drive flange 48 and perforator 16 to move downward (towards container 100b).

[0068] As can be seen in Figs. 5 and 6, when the perforator 16 is in the piercing position, the arms 22 and members 50 fall onto the shell 12 substantially flush with its body. The perforator 16 is moved completely downwards. The flanges 42 are locked between / around the protrusions 44. The arms 22 also define at their distal ends locking holes 54 which are engaged and latched onto the knobs 56 extending from the shell 12. The frictional or snap engagement of the holes 54 and knobs 56 serves to hold the perforation assembly 10 in the locked position after piercing engagement and after fluid engagement with the container 100b. [0069] A pair of sealing flanges 58 extends from the shank 36, near the bevelled tip 34 and the ribs 38.

[0070] As calculated in Figs. 2 to 5, the perforator 16 includes or is initially attached to the removable safety or tamper tab 20. When the tab 20 is connected to the perforator 16, the operator is unable to rotate the arms 22 and members 50 inwards towards shell 12 and thereby push perforator 16 down against shell 12 or perforation assembly

10.

[0071] The securing tab 20 includes a ring 24 that extends around the circular flanges 26 of the perforator 16. As discussed in more detail below in connection with Fig. 7, the ring 24 is connected to the flange 26 via a plurality of tear fasteners, such as eight fasteners. The diameter of the ring 24 is greater than the inside diameter of the hollow shell 12, so that the perforator 16 cannot move within the shell 12 until the ring 24 of the locking tab 20 is removed from the collar 26. The diameter of the collar 26 is smaller than the inside diameter of the hollow shell 12. shell 12, as a result of which the collar 26 of the perforator 16 can move within the shell 12 after the ring 24 of the tab 20 is removed from the collar 26.

[0072] The ring 24 of the securing tab 20 is also connected to the handle 28, which includes knurls, perforations, projections or other means that make the handle 28 intuitive and easy to grip and pull. The handle 28 is ergonomically configured to avoid slipping and to provide a larger gripping area away from the shell body 12. The handle 28 may be located substantially vertically with respect to the perforation assembly 10, substantially perpendicular or at any suitable angle to the assembly. The operator grips the handle 28 and detaches the ring 24 from the perforator 16 by breaking a plurality of e.g. eight fasteners.

[0073] As can be seen in Figs. 7 and 8, the ring 24 is connected to the flange 26 via a number of attachments 60, e.g., eight attachments. The number, size and / or shape of the fasteners 60 are selected so that the disengagement of any single fastening is relatively easy, while the total strength of the tamper resistance provided by the sum of the fasteners 60 is large enough so that the ring 24 of the tab 20 does not release in a manner unintentional from the flange 26 of the perforator 16.

[0074] In the illustrated embodiment, the attachments 60 are shaped as tetrahedrons, such as the correct tetrahedron (i.e. all sides of the triangular surfaces have the same length). In the embodiment illustrated here, one of the surfaces of each attachment 60 is integral or heat9

EP 1 883 386 c1 attached to the ring 24, during essentially point contact with the opposite terminal 60 and the collar 26 of the perforator 16. In this way, the fittings 60 are released from the ring 24 of the tab 20, leaving the edge of the collar 26 at least relatively clean as a result of which the collar 26 of the perforator 16 can move unhindered by the shell. It should be noted that, however, shell 12, ring 24 and flange 26 may be dimensioned such that one of the surfaces of each attachment 60 is integral or attached to flange 26 during substantially point contact with the opposing terminal 60 and tab 24 of tab 20 .

[0075] As can be seen in Fig. 8, the geometry and orientation of each attachment 12 provides the lowest tear resistance in a direction at least substantially perpendicular to the plane 26 of the perforator 16 flange (in a direction at least substantially parallel to the shank 36 of the perforator 16 and shown by the force arrows f and F). For example, point contact with a triangular shape having 0.6 mm in height and 0.3 mm in width may allow a tensile strength f (for attachment 60) of about five to ten newtons. Assuming eight fasteners 60, the total combined resistance force F obtained is about forty to about eighty newtons. Using the configuration described above, the breaking strength and the breaking strength F can be optimized.

[0076] Thanks to the perforation assembly 10 installed in the valve 30 and with the securing tab 20 removed, the arms can be pressed inward to displace the perforator 16 and to pierce the valve 30 of the solution container 100b. An operator connects a device, such as a feeding set with a Luer connector, to the perforator 16 in a fluid-tight manner by removing the cap 18 and connecting the device via a thread located at the top of the perforator 16. Fluid flows from the container 10Ob, through the shank 36 of the perforator 16, through the delivery set, and into the body of the patient or other container. In one embodiment, the different fluids inside the container 100b are premixed before the above described fluid connection is made.

[0077] It should be understood that various changes and modifications in the presently preferred embodiments described in this document will be understood by those skilled in the art.