Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/202—Separating means
  • A61J1/2024—Separating means having peelable seals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
  • A61M39/221—Frangible or pierceable closures within tubing
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/76—Making non-permanent or releasable joints
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/01—General aspects dealing with the joint area or with the area to be joined
  • B29C66/05—Particular design of joint configurations
  • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
  • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
  • B29C66/112—Single lapped joints
  • B29C66/1122—Single lap to lap joints, i.e. overlap joints
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
  • B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
  • B29C66/43—Joining a relatively small portion of the surface of said articles
  • B29C66/431—Joining the articles to themselves
  • B29C66/4312—Joining the articles to themselves for making flat seams in tubular or hollow articles, e.g. transversal seams
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2207/00—Methods of manufacture, assembly or production
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
  • B29C65/04—Dielectric heating, e.g. high-frequency welding, i.e. radio frequency welding of plastic materials having dielectric properties, e.g. PVC
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
  • B29C65/08—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using ultrasonic vibrations
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/80—General aspects of machine operations or constructions and parts thereof
  • B29C66/84—Specific machine types or machines suitable for specific applications
  • B29C66/857—Medical tube welding machines
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
  • B29L2023/00—Tubular articles
  • B29L2023/005—Hoses, i.e. flexible
  • B29L2023/007—Medical tubes other than catheters
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
  • B29L2031/00—Other particular articles
  • B29L2031/712—Containers; Packaging elements or accessories, Packages
  • B29L2031/7148—Blood bags, medical bags

Definitions

• the present invention relates to a peel seal tube closure for a medical container, a medical container comprising a tube with a peel seal tube closure and a hand tool to open said peel seal.
• Plastic film containers such as bags for the administration of medical fluids are known. These containers are made from flexible film which is folded and sealed together along peripheral side edges. Further, the containers typically have an inlet and an outlet. The containers further typically have a device for piercing the outlet and establishing a fluid communication between the patient and the solution inside the container.
• the solution may then be exhausted from the device to an administration set and/or patient.
• medical fluids are liquid medicaments, substitution fluids, blood, or solutions for peritoneal dialysis or hemofiltration treatment.
• the medical fluid bags comprise a short tubing, which is attached to the fluid bag by gluing or welding.
• the tubing also comprises one or more means to close the container. Said means known in the art include caps, rods or frangible pins. The latter are opened by kinking the tube and at the same time breaking the pin inside the tube. Examples of frangible pins are depicted in figure 1 (top and middle figure) .
• Peritoneal dialysis (PD) solutions are one type of dialysis solutions which are typically supplied in film containers.
• frangible pins are used to control fluid pass in PD bag systems.
• Frangible pins in their closed state isolate the PD solution from outer environment.
• the frangible pin is broken and PD solution flows into patient or into an APD machine.
• the present invention relates to a peel seal tube to releasably close a medical fluid container.
• Peel seams are known in multi-chambered plastic film containers. These seams releasably separate the individual chambers of such multi-chamber containers. Prior to use, the seam is opened by exerting pressure on at least one of the liquid-filled chambers and the content of the two or more chambers is thoroughly mixed.
• the present invention relates to a peelable tube seal which is designed to control fluid pass and has the same function as a frangible pin.
• the peelable tube seal of the present invention has several advantages over conventional closing means. It does not require any manual assembly of a frangible pin and a tube. It can be adapted to an automated process and thereby increasing production output. Furthermore, it is cost-efficient because it does not require the plastic frangible.
• the tube seal of the present invention is made by a process comprising the following steps:
• the melting of the tube material in the compressed zone in step (II) can be achieved by thermal heat, radio frequency energy or ultrasonic energy.
• the shape of the tube can be circular, angular, oval, hexagonal or octagonal. In a preferred embodiment of the present invention the tube has a circular shape.
• FIG. 2 shows a medical container with a peelable tube seal according to the present invention the present.
• a solution bag (1) is equipped with at least one tube (2) , which acts as a fluid outlet.
• the tube (2) is closed by a welding portion (3) in tube (2) , which releasably closes the bag (1) and tube (2) assembly and prevents the medical fluid inside the bag (1) from flowing out.
• the releasable welding portion (3) is as shown in Figure 3.
• To open the peelable seal pressure is exerted perpendicular to the longitudinal axis of the tube (2) and at the same time parallel with or along the welded portion (3) .
• the opening of tube seal is typically done by a pinch grip of the thumb and an opposing finger of the same hand, e.g., the index finger or the middle finger.
• FIG. 4 The process of opening the container and releasing the medical fluid is shown in Figure 4.
• the solution bag (1) is closed by the releasable tube seal or welding portion (3) .
• Fig. 4 left When, e.g., a PD treatment cycle begins, the patient or a nurse squeezes the releasable welding (3) to open the container and PD solution can flow out of solution bag (1) through tube (2) into the patient or a PD cycler.
• the tube seal has a predominantly linear shape. In further embodiments of the present invention the seal may have a non-linear shape.
• Figure 5 shows alternative embodiments of the peelable tube seal of the present invention with different welding line shapes. By using different welding line shapes and dimensions, the tube can be reopened fully or partially with different reopening force. In yet another embodiment of the present invention more than one peelable welding can be combined for use in the tube.
• the peelable tube of the present invention is preferably opened manually by exerting pressure along the seal on opposing sides of the tube. This can be done by a pinch grip of thumb and the index finger of the same hand.
• the force a subject can exert in a pinch grip depends on sex, age and overall physical condition of the subject. Typically, younger, fitter persons can produce higher pinch forces than elderly persons. Higher pinch forces can be found with men compared to female test persons.
• the required pinch force must not exceed a maximum value. In a preferred embodiment of the present invention the maximum pinch force required to open the seal is below 100 N, preferably below 90 N.
• the maximum pinch force required to open the seal is below 60 N, preferably below 50 N.
• a minimum opening pinch force is necessary to avoid premature opening of the seal and a leakage during handling and transport.
• the minimum opening pinch force can be adjusted to the bag volume, the tube diameter, the tube material and the expected transport conditions.
• the seal can be opened by a hand tool, which leverages the force of the fingers and thereby reduces the effort.
• a hand tool is particularly useful to help elderly patients to open the peel seal of the present invention without the help of others.
• Yet another application of said hand tool is to further increase the required pinch force necessary to open the peel seal of the present invention as mentioned above to values higher than 100 N and still enabling a great variety of persons to open the peel seal.
• FIG. 6 shows an embodiment of tool. It comprises the following parts: top handle (4) , rotating shaft (5) , bottom handle (6) .
• the top handle (4) can rotate around shaft (5) .
• the means to hold the tube in place for opening comprises at least one latch.
• Figure 7 shows the process to open a tube seal with a hand tool as described above.
• a first step the tube with the peelable tube seal onto the slots of bottom handle 6.
• the top handle 4 is rotated and pressed onto the bottom handle 6 to squeeze the tube until the seal is opened.

Landscapes

• Engineering & Computer Science (AREA)
• Health & Medical Sciences (AREA)
• Mechanical Engineering (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Heart & Thoracic Surgery (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Hematology (AREA)
• Pulmonology (AREA)
• Biomedical Technology (AREA)
• Anesthesiology (AREA)
• Physics & Mathematics (AREA)
• Fluid Mechanics (AREA)
• Pharmacology & Pharmacy (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

Applications Claiming Priority (1)

Publications (2)

Family

ID=76687518

Family Applications (1)

Country Status (3)

Family Cites Families (6)

• 2019
  • 2019-12-31 CN CN201980103355.4A patent/CN114929460A/zh active Pending
  • 2019-12-31 WO PCT/CN2019/130522 patent/WO2021134486A1/en unknown
  • 2019-12-31 EP EP19958639.7A patent/EP4084948A4/de active Pending

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