MXPA98000838A - System of supply of solution with an individual final packaging, integrated and a method to pack my - Google Patents

Abstract

The present invention relates to a solution supply system comprising: a rigid container with walls defining an interior, wherein the rigid container has an open end and a closed end: a lid attached to the open end of the rigid container wherein the The lid includes a port that provides fluid communication with the interior of the rigid container, and a container with an interior filled with a solution, which has one end of a tube that extends from it where the tube is connectable to the port on the side.

Description

"SOLUTION SUPPLY SYSTEM WITH AN INTEGRATED INDIVIDUAL FINAL PACKAGING AND A METHOD TO PACK THE SAME." BACKGROUND OF THE INVENTION The present invention relates in general to a system for supplying a solution and a method for packaging the same. In particular, the present invention relates to a substance delivery system used for ambulatory, peritoneal, continuous dialysis (CAPD) and a method for packaging the same.

Commonly the packages for CAPD systems consist of a solution container, which generally contains peritoneal dialysis solution, which is joined, by a set of Y-shaped tubes and a connector, to an empty drain container. The drainage container is designed to receive at least one and one and a half times the nominal volume of the solution container. The complete CADP system, for example, the filled bag, the Y-shaped set and the empty bag, are wrapped in a bag to be stored before being used by the patient. Commonly, they are sent to end users, such as patients requiring peritoneal dialysis, the sterile products required for use with the CADP system. Normally the sterile products are packaged in a corrugated cardboard box. As a result of the packaging currently used, the CADP patient needs to open a cardboard, break a bag and remove one or more corrugated boxes each time he starts a dialysis procedure.

Because many CADP patients also suffer from arthritis, these tasks are often difficult to perform.

Additionally, storage requirements in current systems before being used are commonly burdensome, due to the amount of space needed for packaging. Namely, flexible packaging bags do not keep a specific shape, so it is difficult to stack the products. Additionally, identifying the product is difficult with current packaging systems. Another complex procedure using the current system is to evacuate the dialysis used. With the systems currently available, patients normally use scissors to cut the end or corner, or drainage line, or port tube of a flexible, filled drainage container in order to evacuate the fluid used. In addition to the above, after the product is used, the amount of waste materials is bulky. A bag and a cardboard box must be discarded, requiring a significant amount of space.

Another disadvantage of the current system is that the packaging of the current system is not well protected and is prone to cosmetic damage, such as the collapse of components, the entanglement of pipes, the gluing of components or the tearing of components. Handling is difficult, because packaging requires more care and, as a result, less automation can be implemented. Therefore, there is a need for an improved system that can be integrated with the final package, to be used by patients who are subject to CADP, as well as a method of supplying a solution.

SUMMARY OF THE INVENTION The present invention provides a CAPD delivery system with a final, individual, integrated package. Additionally, the present invention provides a method for packaging a system to be used by patients who are undergoing CADP, as well as a method for patients undergoing CADP using an integrated package delivery system. For this purpose, in a prototype, a solution supply system is provided. The system has a rigid container having walls defining an interior where the rigid container has an open end and a closed end. A lid is attached to the open end of the rigid container, wherein the lid includes a port that provides fluid communication with the interior of the rigid container. A container is filled with a solution, having a portion of tube that extends from this to the port of the lid, the tube is connectable via a manifold tube. In a prototype, a connector is provided at the end of a portion of the tube where the connector connects the tube and the port over the top. In a prototype, the container with the solution and the pipe are placed inside the rigid container before joining the lid. In a prototype, a connecting device is associated with the port on the door. In a prototype, the walls of the rigid container are molded to form a serrated section. In a prototype, the walls of the rigid container are tapering. In a prototype, a scale is incorporated on the wall of the rigid container. The scale can be printed or engraved. In a prototype a transparent window is incorporated in the wall of the rigid container. In a prototype, the container solution is used for peritoneal dialysis. In a prototype, the rigid container is made of recyclable material.

In a prototype, the rigid container, lid and / or container is constructed of a material that includes a bactericidal or bacterial agent. In a prototype, the lid is distinguished by color from the rigid container. In a prototype, the lid and / or the rigid container include tactile shapes to allow differentiation to a blind or visually impaired patient, for example, from the solutions contained in the solution container. In another prototype of the present invention, a method for packaging a system required for use in a dialysis process is provided. The method comprises the steps of: providing a first container with an interior defined by walls, providing a second container containing the solution and connected in fluid communication with a portion of the tube; placing the second container and the tube portion in a first container; and joining the first container with a lid. In a prototype, THE METHOD FURTHER UNDERSTANDS THE STEP TO FORM THE FIRST CONTAINER IN SUCH A WAY THAT AT LEAST ONE OF THE WALLS OF THE FIRST CONTAINER IS DESIGNED TO HANDLE. In a prototype, the first container is made of a rigid material.

In a prototype, the method further comprises the steps of. providing a third container having a lid for enclosing an interior of the third container, and stowing the third container on the lid of the first container. In a prototype, the method further comprises the step of providing a scale on the wall of the first container. In a prototype, the method further comprises the step of providing a built-in window to the walls of the first container. In a prototype, the method further comprises the step of forming a first container with a semicircular corner at an open end on which the lid is secured to encircle the first container. The lid, in a prototype, can include a section that can be opened and removed to allow the first container to be emptied. In another prototype of the present invention, a method is provided for delivering a solution to a patient. The method comprises the steps of: providing a first container with walls defining an interior, the first container having a cover wherein the cover includes an access port to provide access to the interior of the first container; connecting a first end of a pipe to the access port of the cover, providing a second container containing a solution; connecting a second end of tubing to one end of the second container and the patient to its other end, and allowing the solution to flow from the second container to the patient.

In a prototype, the method further comprises the step of connecting the first end of the pipe to the second end of the pipe. In a prototype, the method further comprises the step of draining solution from the container through the first end of the pipe to the first container. In a prototype, the method further comprises the step of monitoring the filling of the first container during draining from the patient. In a prototype, the first container is made of rigid material. Therefore, it is an advantage of the present invention to provide a system and a method that simplifies peritoneal, ambulatory, continuous dialysis CADP. Another advantage of the present invention is to provide a system and method for packaging products required for CADP. Yet another advantage of the present invention is to provide a system and method wherein a part of the package is used for CADP. Another additional advantage of the present invention is to provide a system and method that simplifies the use of the patient that is subject to CADP. Yet another advantage of the present invention is to provide a system and method for easy storage and identification of a CADP product. Another advantage of the present invention is to provide a system and method for packaging a product used for CADP where the product is readily identifiable.

Another advantage of the present invention is to provide a system and method for packaging a CADP product that simplifies use by monitoring and controlling the volume of fluid drained during the draining phase of the process. In addition, another advantage of the present invention is to provide a system and method for packing CADP wherein the product is protected and is not prone to cosmetic defects. Another advantage of the present invention is to provide a system and method for packaging a CADP product wherein the handling of the product can be automated and simplified. Another advantage of the present invention is to provide a system and method for packing components required in CADP that reduce the amount of material that must be discarded. Another advantage of the present invention is to provide a system and method for packing components required for CADP which reduces the time required to carry out a change. Additional forms and advantages of the present invention are described, which will become apparent from the detailed description of the prototype and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates a schematic diagram of a prototype of the components necessary to carry out a dialysis procedure using the package of the present invention. Figure 2 illustrates a perspective view of a plurality of sets of packages as used in a dialysis process with the present invention. Figure 3 illustrates a perspective view, partially in cross section, of a prototype of the components necessary to carry out a dialysis procedure inside a rigid container. Figure 4 illustrates a high side view of the components necessary to carry out the dialysis procedure connected to a rigid container in a prototype of the present invention. DETAILED DESCRIPTION OF THE PROTOTYPES The present invention provides a system and a method for packaging. Specifically, the present invention provides a system and method for packaging the components that are required to perform a dialysis procedure, such as peritoneal, ambulatory, continuous dialysis (CADP). Referring to the drawings in which the numbers refer to parts, Figure 1 illustrates a prototype of a system 1 of components necessary to carry out CADP using the package of the present invention which will be described when referring to the remaining figures. . In Figure 1, a container 10 is shown. The container 10 is made of flexible plastic and contains a volume of solution 12. The material with which the container 10 is manufactured can also provide a barrier to gas, light and water vapor to allow a sufficient life of the solution 12 and to avoid the degradation of the solution while it is stored by the penetration of gas or light. Of course other types of materials for container 10 can be implemented by those skilled in the art. The container 10 is connected to a drug access port 14 which can selectively add medication to the solution 12 in the container 10. Alternatively, the solution 12 within the container 10 can be drained from the container 10 via the medicine access port. 14. The interior of the container 10 containing the solution 12 is in fluid communication with the administration line 16. The administration line 16 is connected to a multiple junction 18, such as the Y-shaped connector illustrated in Figure 1. Inside of the multiple seal 18 there is a shut-off valve 20 which controls the administration of the solution to and from the patient using the system 1. The shut-off valve 20 is connected to the multi-joint 18. Preferably, the shut-off valve 20 is sealed by a cover or protector (not shown) to maintain sterility in the system 1. A drainage line 22 is connected to an opposite leg of the multiple joint. ple 18 y, back is connected at its end to a closing drainage connector / line, the multiple joint 18 can allow the connection of a plurality of solution containing bags to the drainage line 22. Of course, clamps and others can be added. Accessories to system 1, such as an online medication port, an in-line valve, etc. Referring to Figure 2, a plurality of rigid containers 26 are shown stacked side by side. Rigid containers 26 are specifically designed with an exterior wall that tapers, such that the base of a rigid container 26 can stand on top 28 of an adjacent rigid container 26. Also, tapered walls allow rigid containers 26 are stored one inside the other when the lids 28 are removed from the rigid containers 26. Alternatively, the rigid container 26 may be designed and / or manufactured to be collapsible. The materials of the container 26 can be rigid or semi-rigid, and / or the design of the container 26 can be such that, for example, the weak sections can collapse under a sufficient load. As illustrated, the doors 28 of each of the rigid containers 26 include an access port 30, through which fluid, selective communication can be achieved with an interior of the rigid container. Through the center of the access port 30 there is a connecting device, like a rigid bolt. The connector apparatus 32 is used to penetrate the closure drain line / connector 224 of the system 1. The cover 28 further includes a seal 24 within an interior of a recess area 36 for receiving one end of the rigid container 26. The seal 34 of the lid 28 forms a non-permanent, waterproof seal for the rigid container 26. The lid 28 also includes an edge 29 to help remove the lid 28 of the rigid container 26. The rigid container 26 is designed with integrated grasping or handling means 38 along the two outer sides of the rigid container 26. The handle 38 may be designed as a molded, toothed area of the rigid container 26 that allows an individual to take the rigid container and move it as desired. One end 40 of the rigid container 26 is substantially semicircular at the opposite end of the handle 38. The semicircular shape of the end 40 provides integrated means for emptying the solution from the rigid container 26. The rigid container 26 may also include a graduated scale 42. The scale 42 may be molded in a wall of the rigid container 26, or it may be printed in some other way on the rigid container 26 such that when the solution is emptied into the rigid container, it may be partially seen through the walls of the rigid container. 26 and the amount of solution within the rigid container 26 can be measured by the scale 42. Alternatively, the rigid container 26 can include a window, either transparent or translucent, through which the solution of the container 10 can be seen. The transparent window can also include its own graduated scale to indicate the amount of solution inside the rigid container or 26. The rigid container 26, although described as rigid, can also be made of a semi-rigid material. The material of the rigid container 26 can be selected to guarantee the shelf life of the CADP product inside the container, for example, material of low percentage of water vapor transmission. Alternatively, the material can also be selected to ensure the integrity of the CADP solution, for example, material against gas or material against light.

The raw material of container 26 can also be selected to prevent mold growth during the storage period of the CADP product. Additionally, a selected material can allow multiple uses of the same container. For this purpose, the container must include a material that contains a bactericidal or bactero-static agent. While the cover 28 has been described as containing an access port 30 with a connector apparatus 32, the access door 30 may alternatively include a membrane, a lock system, a separator or the like which can be used in conjunction with the closing drainage line / connector 24. The lid 28 also includes micro-perforations (not shown) to allow ventilation of the closed container without jeopardizing the permeability of the rigid container 26 and the lid 28. A protective dust tongue (not shown) to cover the access port 30 and, if needed, the micro-perforations included in the door 28 to prevent the entry of any contaminant, to avoid a spill or something similar. The material of the door 28, like the rigid container 26, can be selected to ensure the integrity of the CADP solution and can be selected to prevent mold growth during the storage of the CADP product. In addition, the door 28 and / or the rigid container 26 should be color coded to differentiate between the different products that can be contained in the rigid container 26 and the associated components that can be used. Preferably, the rigid container 26 and the lid 28 are injection molded; however, the final, individual, integrated packaging can be obtained from a thermal forming manufacturing process. Additionally, instead of preventing mold growth using a specific mixture of materials for the rigid container 26 and the lid 28, the volume determined by the rigid container 26 and the lid 28 can be sprayed with a sufficient amount of antibacterial gas through of an appropriate access door constituted of a re-sealable valve, for example, a separator, an elastomeric access *, etc., or the container may contain a quantity of disinfectant liquid, such as hypochlorite or the like. In addition, a tablet containing active disinfectant in the volume determined by the rigid container 26 and the lid 28 can be placed inside the container. Referring to Figure 3, the partially cut rigid container 26 is illustrated in which the system 1 shown in FIG. Figure 1 can be placed completely inside the container 26 and isolated by the door 28 to be sent and stored. As a result, system 1 including container 10 filled with solution 12 is protected from cosmetic defects, such as damage from accidental penetration of container 10, or the like. In practice, the system 1 is removed from the rigid container 26 and connected as illustrated in Figure 4 in such a way that the drainage / connector closure line 24 is connected to the access port 30 in the lid 28 of the rigid container 26. Via the connector 15 of system 1, a tube end (not shown) can be connected to provide fluid communication between System 1 and a delivery point, such as a patient undergoing peritoneal dialysis. As a result, the patient's peritoneum can be drained through the tube end taken to the patient. The amount of solution drained within the rigid container 26 can be monitored via scale 42 (or scale window) on an outer wall of the rigid container. After the draining and infusion procedures are completed, the solution within the rigid container 26 should be emptied by removing the lid 28 from the rigid container 26 using the handle 28 and the end in the form of a drain tube. In the latter case, the rigid container 26 can be reused for subsequent procedures, replacing the system! in the rigid container 26. Although the present invention has been described with reference to a peritoneal dialysis method, it should be understood that the present invention is adaptable to other fluid control systems, such as intravenous feeding. It should be understood that various changes and modifications to the prototypes described in the present invention will become obvious to those skilled in the art. Said changes and modifications can be made without departing from the spirit and objective of the present invention and without diminishing its advantages. Therefore, it is intended that said changes be covered by the following claims.

Claims (1)

1. CLAIMS 1. A solution supply system comprising: a rigid container with walls defining an interior, wherein the rigid container has an open end and a closed end: A lid attached to the open end of the rigid container wherein the lid includes a port that provides fluid communication with the inside of the rigid container; and A container with an interior filled with a solution, having one end of a tube extending therefrom where the tube is connectable to the port on the lid. The system of Claim 1 further comprising: a connector at one end of the tube length where the connector connects the tube and the port on the lid. 3. The system of Claim 1, wherein the container with the solution and the tube are placed in the rigid container before closing the rigid container with the lid. 4. The system of Claim 1 further comprising: a connector apparatus associated with the port on the lid. 5. The system of Claim 1 wherein the walls of the rigid container are molded to form a serrated section. 6. The system of Claim 1 wherein the walls of the rigid container are tapered. The system of claim 1 further comprising:., A scale incorporated into the wall of the rigid container 8. The system of Claim 7 wherein the scale is printed. 9. The system of Claim 7 where the scale is recorded. 10. The system of Claim 1 further comprising a transparent window incorporated into the wall of the rigid container. 11. The system of Claim 1 wherein the solution in the container is used for peritoneal dialysis. 12. The system of Claim 1 wherein the rigid container is made of recyclable material. 13. The System of Claim 1 wherein the rigid container is constructed of a material that includes a bactericidal or bactariostatic agent. 14. The system of Claim 1 wherein the lid has a different color from the rigid container. 15. A method to pack a system required to carry out a dialysis procedure, the method comprises the steps of: Providing a first container with an interior defined by walls; Provide a second container filled with solution and connected in fluid communication with a tube; Place the second container and tube inside the first container; and Close the first container with a lid. 16. The method of Claim 15 further comprising the steps of: Providing an access port on the lid that closes the first container. The method of Claim 15 further comprising the step of: forming the first container so that at least one of the walls of the first container is designed to be gripped. 18. The method of Claim 15 wherein the first container is made of rigid material. The method of Claim 15 further comprising the steps of: Providing a third container with a lid to close an interior of a third container; and Stow the third container on the lid of the first container. 20. The method of Claim 15 further comprising the steps of: Provide a scale on the walls of the first container. 21. The method of Claim 15 further comprising the step of: Providing a built-in window to the walls of the first container. 22. The method of Claim 15 further comprising the step of: forming the first container with a semicircular corner at an open end on which the lid is secured to close the first container, 23. A method for delivering a solution to a patient , the method comprises the steps of: Providing a first container with walls defining an interior, the first container having a lid that includes an access port to provide access to the interior of the first container; Connect a first portion of the tube to the access port on the lid; Provide a second container that contains a solution; connecting a second portion of tube to the second container at one end and to the patient at its other end; and Allow the solution to flow from the second container to the patient. 24. The method of Claim 23 further comprising the step of: Connecting the first tube portion to the second tube portion. 25. The method of Claim 23 further comprising the step of: Draining the patient's solution through the first tube portion to the first container. 26. The method of Claim 23 further comprising the step of: Monitoring the filling of the first container during draining of the patient. 27. The method of Claim 23, wherein the first container is made of rigid material.