WO2020044075A1 - Dispositif pour raccorder des cathéters et des tubulures dans un milieu stérile - Google Patents

Dispositif pour raccorder des cathéters et des tubulures dans un milieu stérile Download PDF

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Publication number
WO2020044075A1
WO2020044075A1 PCT/IB2018/056527 IB2018056527W WO2020044075A1 WO 2020044075 A1 WO2020044075 A1 WO 2020044075A1 IB 2018056527 W IB2018056527 W IB 2018056527W WO 2020044075 A1 WO2020044075 A1 WO 2020044075A1
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WO
WIPO (PCT)
Prior art keywords
catheters
sterile
cover
chamber
sterile chamber
Prior art date
Application number
PCT/IB2018/056527
Other languages
English (en)
Spanish (es)
Inventor
Cynthia Isabel MEJÍA LUCERO
Alejandra ROMÁN CARTAGENA
Original Assignee
Mejia Lucero Cynthia Isabel
Roman Cartagena Alejandra
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mejia Lucero Cynthia Isabel, Roman Cartagena Alejandra filed Critical Mejia Lucero Cynthia Isabel
Priority to PCT/IB2018/056527 priority Critical patent/WO2020044075A1/fr
Publication of WO2020044075A1 publication Critical patent/WO2020044075A1/fr

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    • 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
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • 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
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/18—Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking

Definitions

  • the disclosed invention consists of a device for connecting catheters and other types of pipes in a sterile environment.
  • a disposable medical device that has a sterile chamber inside which catheters and pipes can be connected, and which can include a disinfection means for sterilization of catheters and pipes that are connected within said sterile chamber.
  • IRC Chronic Renal Failure
  • CKD is a degenerative disease that occurs when the kidneys are not able to adequately filter toxins and other waste substances from the blood.
  • PD involves placing a soft tube or catheter in an abdominal cavity of the patient and filling it with dialysis solution.
  • This solution contains a type of glucose that eliminates excess endogenous metabolic products and blood waste. Waste and liquid pass through the blood vessels through the peritoneum to the solution. After a certain period, the solution and waste are drained and discarded.
  • PD is not a cure, but a palliative treatment that eliminates symptoms and prolongs the patient's life. Therefore, without a kidney transplant or other treatment that provides a definitive cure, the patient should continue with PD for the rest of his life.
  • the high cost of the PD limits its application and constitutes the main long-term impediment to continue it; Few patients have sufficient financial solvency to pay for continuous treatment throughout the life of a patient, which can be extended for many years. In many cases, the patient must receive a PD treatment multiple times a day.
  • a semi-permanent catheter is currently placed in the patient, so that the peritoneum does not have to be channeled each time a PD treatment is performed. This implies that the patient has to live with the catheter in his body connected to his peritoneal cavity. This catheter is called the Transfer Line (LT) or Tenckhoff catheter.
  • LT connects to dialysis bags.
  • One is the Bag with infusion solution, and the other is the Bag for drained solution.
  • the bag with infusion solution is removed from the protective packaging and is hung from an intravenous support or from another elevated place.
  • the empty drained solution bag is placed somewhere below the plane where the LT is connected, usually on the floor or on a low table.
  • the two bags are connected to each other by a three-phase catheter - a type of catheter with three connections -: One connection joins the Bag with infusion solution, another connection joins the Bag for drained solution, and another one joins LT.
  • the claimed device is composed of at least one sterile chamber, the body of which consists of a soft and translucent material, such as silicone or latex.
  • the soft construction material allows torsion of the sterile chamber, so that the elements inside can be easily handled from the outside.
  • the body of the sterile chamber serves as a barrier between the operator's hands - which may have pathogens - and the materials inside.
  • the sterile bedroom has at least one bedroom opening, which is an unclosed portion of said bedroom.
  • the chamber opening is protected by at least one lid, which maintains the sterile environment inside the chamber, and inert gas or pressure difference in the chamber.
  • Disinfection Medium helps to clean or disinfect any pipe or catheter that is introduced into the sterile Chamber through the Lid.
  • the disinfection medium may be protected by at least one fluid trap that prevents the flow of the disinfection medium into the sterile chamber or by the lid to the outside.
  • the device can be recycled if it is manufactured in the preferred mode, reducing the impact on the environment, and allowing other business models that include the product recycling phase.
  • the device type OLI works with any type of pipe or catheter, so, although the device was designed to solve problems related to the application of the DP procedure, it can actually be used for the connection of any type of catheters and pipes that require to be connected in a sterile environment.
  • the OLI type device is easy to store and transport, which reduces the overall costs for patients and health professionals that include them as an integral element in the PD procedures they perform.
  • the OLI Device is not reusable, so its sterility status is ensured, and it can be recycled to lessen the environmental impact of its use in continuous volume.
  • the OLI Device 100 is constituted by at least one sterile chamber 120 and at least one cover 110.
  • the OLI Device 100 has a sterile chamber 120 and two covers 110.
  • the sterile chamber 120 is manufactured with a structurally resistant, soft material, and susceptible to torsion, extension, and compression.
  • sterile chamber 120 is constructed using a soft and translucent polymer. Examples of suitable materials are silicone and latex.
  • the sterile chamber 120 includes extension folds 122, which allow a greater twist of the sterile chamber 120, since they constitute folds of the same material with which said chamber has been manufactured, and that to twist on the body of the chamber, They allow movements to travel a greater distance on any axis.
  • extension folds 122 allow a greater twist of the sterile chamber 120, since they constitute folds of the same material with which said chamber has been manufactured, and that to twist on the body of the chamber, They allow movements to travel a greater distance on any axis.
  • a support adheres to the average horizontal Diameter of the chamber 123 to give structural strength to the sterile Chamber 120.
  • the support can be constituted by a ring that runs the full extent of the average horizontal Diameter of the chamber 123. Said ring it can be of a structurally stronger polymer, or of the same polymer as the body as the sterile chamber 120, but with a higher density.
  • the support can be constituted by posts that run at least some portion of the average horizontal Diameter of the chamber 123.
  • the support may be constituted by an increase in the material with which the sterile Chamber 120, of so that part or all of the average horizontal diameter of the chamber 123 has a greater amount or density of material, which provides rigidity or support.
  • At least one distal end of the sterile chamber 120 is located a chamber opening 121, which must be completely covered by at least one cover 110.
  • the cover 110 must have a geometric shape compatible with the chamber opening 121, so that a suitable seal can be ensured that maintains the aseptic environment of sterile chamber 120.
  • sterile chamber 120 has two chamber openings 121, one at each distal end.
  • the covers 110 are attached to the chamber openings 121 with a fastener.
  • the fastener is cement.
  • the fastener is a heat-generated joint that fuses the body of the sterile chamber 120 into the Cap 110.
  • the fastener is a flange of the Cap 110 folded so that it catches the material with which the sterile chamber 120 is constructed and the two elements together.
  • the cover 110 may be constructed of a suitable and resistant material, such as a metal such as aluminum, or a polymer such as silicone or PET.
  • Caps 110 can be constructed in multiple ways.
  • the Cap 110 is a press type and has five main elements, namely a Base of the cover 111 without movement, a Cover of the cover 112, attached to the Base of the Cover 111 by a Hinge 114, and a Snap 115 which allows the closure of the Device.
  • a Cover Surface 113 is attached to the Cover Cover 112 and another Cover Surface 113 adheres to the Cover Base 111.
  • each Cover surface 113 is arranged in such a way as to allow the Cover 110 to be opened using the Hinge 114, but so that closing the Cover 110 with the aid of the Snap 115 generates a seal.
  • the cover surfaces 113 use a soft material, such as a sponge, latex, or silicone, so that they create the desired seal, but do not interrupt the flow to and from the Transfer Line 200 and the Catheter three-phase 500.
  • the Cover Surfaces 113 are attached to the Cover Base 111 and the Cover Cover 112 with a clamping means.
  • the fastening means is cement.
  • the fastener is a heat-generated joint that fuses the Cover Surface 113 with the Cover Base 111 or the Cover Cover 112, respectively.
  • the cover surfaces 113 are manufactured as the same element as the cover base 111 and the cover cover 112, so that the cover base 111 and its correlative cover surface 113 are a single element, and the Cover cover 112 and its correlative Cover surface 113 are also a single element; In this mode, the Cap 100 and its elements will be manufactured with a soft material so that they do not interrupt the flow to and from the Transfer Line 200 and the three-phase Catheter 500.
  • the Cap 110 is a diaphragm cap, so that the Cap Surface 113 is an iris or diaphragm that, when closed, fixes the position of the catheter or tubing in the center of said diaphragm.
  • the Cap 110 is a chuck type of jaws.
  • the Cap 100 is an endless clamp cover.
  • the Cover 100 is a quick clamp type clamp.
  • the OLI Device 100 includes a Disinfection Medium 130 that helps maintain the sterility standards of the catheters that will be connected.
  • the disinfection medium may consist of a sponge impregnated with a disinfectant solution, or it may be a fluid or colloid that satisfies the same function. In case it is desired to place a sponge, it may have at least one cut that allows a catheter or pipe to pass through it, from the Cover 110, and into the chamber Opening 121.
  • the Disinfection Medium 130 It will be contained by at least one Fluid Trap 131, which prevents the filtration of the disinfectant solution or its evaporation while stored or unused.
  • two fluid traps 131 will be placed in each Cap 110: One between the chamber opening 121 and the disinfection medium 130, and another between the disinfection means 130 and the cover surfaces 113, as can be seen in Figures 2 and 3.
  • the fluid traps 131 are attached to the diameter of the lid base 111 with a clamping means, so as to achieve a tight seal to prevent filtration or evaporation of the disinfection medium 130.
  • the traps Fluid 131 have a thickness that allows them to be pierced or broken by a catheter, and can be constructed of an appropriate material such as tin, aluminum, copper, steel, or a polymer, such as PET or the like.
  • the fluid trap 131 located between the cover 110 and the chamber opening 121 may include a drying or absorbing means - such as paper or cloth - so that a smaller amount of the disinfection medium is filtered 130 inside the sterile chamber 120.
  • the interior of the sterile chamber 120 can be filled with an inert gas, such as Nitrogen, or it can be left under high vacuum. In case the chamber is left under high vacuum, the flow of the dialysis solution is promoted, when moving from the bag with solution for infusion due to pressure differences. If the interior of the sterile chamber is filled with an inert gas, the growth of unwanted pathogens and fungi is prevented, and disinfection of the catheters is also promoted when the pressure inside the sterile chamber is greater than 1 at, because when entering the catheter the pressure difference will cause the inert gas to flow outwards, taking out any pathogens that are outside the walls of the inserted catheter.
  • an inert gas such as Nitrogen
  • the manner of operation of the device is also described.
  • the manner of operation of the device is as follows: The Bag with infusion solution 300 and the Bag for drained solution 400 are placed in position. One end of the three-phase Catheter 500 is connected to each of said bags. The outer end of the Transfer Line 200 and the remaining end of the three-phase Catheter 500 will be connected to each other within the OLI Device 100. To do this, Brooch 115 of a Cover 110 opens, so that the Cover of Cover 112 is lifted with the aid of the Hinge 114.
  • the end of the Transfer Line 200 even with its protective cap pierces the first Fluid Trap 131, passes through the Disinfection Medium 130, and drills the second Fluid Trap 131, so that its free end it remains inside the sterile chamber 120.
  • the end of the three-phase catheter 500 is introduced to the sterile chamber 120 by the cover 110 of the other distal end, in an operation similar to that performed with the end of the Transfer Line 200.
  • the operator then remove the protective covers of both the end of the Transfer Line 200 and the end of the three-phase Catheter 500, taking advantage of the smooth and translucent construction of the sterile Chamber 120, Pressing with each finger each protective cap with the body of the sterile chamber 120 and unscrewing or pulling the protective caps to allow the connection of the two catheters.
  • the body of the sterile chamber 120 prevents direct contact of the operator's hands with the catheters, thus promoting the sterility standards necessary for PD procedures.
  • the operator may connect multiple catheters by inserting each into each port or Cap 110.
  • the OLI Device 100 only has a Cap 110 , or the Cap 110 is sufficiently wide, more than one catheter or tubing may be introduced through each one into the sterile chamber 120.
  • This device can be manufactured and recycled in an industrial way, and can be used in the healthcare industry for the connection of catheters and pipes, in any condition that requires procedures for connecting catheters or pipes in sterile or extremely clean media, such as in DP procedures, for example.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un dispositif médical qui comporte une chambre stérile à l'intérieur de laquelle peuvent être raccordés des cathéters et des tubulures et qui peut inclure un moyen de désinfection pour la stérilisation des cathéters et des tubulures qui se raccordent à l'intérieur de la chambre stérile. La chambre stérile est fabriquée à l'aide d'un matériau mou et translucide qui permet la torsion et la compression, pour manipuler depuis l'extérieur les cathéters et les tubulures raccordés à l'intérieur de la chambre stérile.
PCT/IB2018/056527 2018-08-27 2018-08-27 Dispositif pour raccorder des cathéters et des tubulures dans un milieu stérile WO2020044075A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2018/056527 WO2020044075A1 (fr) 2018-08-27 2018-08-27 Dispositif pour raccorder des cathéters et des tubulures dans un milieu stérile

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2018/056527 WO2020044075A1 (fr) 2018-08-27 2018-08-27 Dispositif pour raccorder des cathéters et des tubulures dans un milieu stérile

Publications (1)

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WO2020044075A1 true WO2020044075A1 (fr) 2020-03-05

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4209013A (en) * 1979-04-05 1980-06-24 Baxter Travenol Laboratories, Inc. Sterile connection system using flexible container
GB2060399A (en) * 1979-09-25 1981-05-07 Avon Medicals Peritoneal dialysis equipment
US4405312A (en) * 1981-08-31 1983-09-20 Abbott Laboratories Connecting device for medical liquid containers
EP0126650A2 (fr) * 1983-05-23 1984-11-28 Japan Medical Supply Company Limited Technique et équipement pour le traitement de la dialyse
US20030158528A1 (en) * 2002-02-20 2003-08-21 Doug's Kangaroo Pouch, Llc User wearable device having sterile environment for connecting peritoneal dialysis tubes
US20060210422A1 (en) * 2005-03-16 2006-09-21 Roberts Roderick R Apparatus and method for sterile interconnection of lines transferring sterile fluids

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4209013A (en) * 1979-04-05 1980-06-24 Baxter Travenol Laboratories, Inc. Sterile connection system using flexible container
GB2060399A (en) * 1979-09-25 1981-05-07 Avon Medicals Peritoneal dialysis equipment
US4405312A (en) * 1981-08-31 1983-09-20 Abbott Laboratories Connecting device for medical liquid containers
EP0126650A2 (fr) * 1983-05-23 1984-11-28 Japan Medical Supply Company Limited Technique et équipement pour le traitement de la dialyse
US20030158528A1 (en) * 2002-02-20 2003-08-21 Doug's Kangaroo Pouch, Llc User wearable device having sterile environment for connecting peritoneal dialysis tubes
US20060210422A1 (en) * 2005-03-16 2006-09-21 Roberts Roderick R Apparatus and method for sterile interconnection of lines transferring sterile fluids

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