WO2020044075A1

WO2020044075A1 - Device for connection catheters and tubes in a sterile medium

Info

Publication number: WO2020044075A1
Application number: PCT/IB2018/056527
Authority: WO
Inventors: Cynthia Isabel MEJÍA LUCERO; Alejandra ROMÁN CARTAGENA
Original assignee: Mejia Lucero Cynthia Isabel; Roman Cartagena Alejandra
Priority date: 2018-08-27
Filing date: 2018-08-27
Publication date: 2020-03-05

Abstract

The invention relates to a medial device that has a sterile chamber inside of which catheters and tubes can be connected and which can include a disinfecting medium for sterilising the catheters and tubes connected inside the sterile chamber. The sterile chamber is produced using a soft translucent material that allows torsion and compression, in order to externally operate the catheters and tubes connected inside the device.

Description

OLI type device for connecting catheters and pipes in a sterile environment

The disclosed invention consists of a device for connecting catheters and other types of pipes in a sterile environment.

Specifically it is 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.

At all times, around 500 million people are affected by Chronic Renal Failure (IRC) in the world. In Mexico, around 9.5 million people live with IRC; It is the fifth cause of death in the country.

CKD is a degenerative disease that occurs when the kidneys are not able to adequately filter toxins and other waste substances from the blood.

In Mexico, more than 80% of CRF patients are treated with Peritoneal Dialysis (PD) with a frequency of up to four times a day.

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.

The time allocated for each liquid exchange is approximately one hour, considering that for all this a thorough cleaning of all the equipment must be carried out to reduce the risk of contamination. 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.

To improve the patient's quality of life, 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.

In the traditional procedure, the patient and the person attending should use a disposable surgical mask, wash their hands with antibacterial soap, and protect their clothing with some disinfected cloth. 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 biggest complications of the procedure are infections. Because LT breaks the protective barriers provided by the integumentary system, and people with renal failure generally have a depressed immune system, infections are common. Therefore, all three-phase Catheter connections, and LT, have connector caps, and bare connections should not be allowed to touch anything to avoid contamination. Additionally, it should be avoided that air enters through the catheters, as infectious vectors can be introduced that endanger the health and even the patient's life.

Therefore, it is necessary to have a device that allows the connections of these catheters to be sterile, low cost, and easy to use.

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.

Inside the Lid Base there may be a Disinfection Medium, which helps to clean or disinfect any pipe or catheter that is introduced into the sterile Chamber through the Lid.

Additionally, 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.

In the state of the art, it is currently required that the operators of the medical devices to perform PD be extremely cautious and neat, so that they can guarantee the sterility of their people and the environment in which they perform the procedures. However, although the level of sterility required for PD is easily achieved in specialized places, such as clinics and hospitals, it is difficult to achieve in patients' homes. Taking into account that those who suffer most from the effects of renal impairments are people with limited resources, it is difficult to have all the technical elements to achieve the required levels of sterility, in addition to socioeconomic conditions that can prevent both patients and those assist them have the necessary knowledge or the ability to understand necessary to meet all requirements.

Among the elements that are required to achieve the minimum sterility standards are disposable surgical masks for patients and operators, antibacterial soaps, and means of disinfection of both catheters and fabrics or clothing, as well as rooms without drafts with good air degree of cleanliness Not all patients have the resources to achieve these elements and achieve the desired conditions.

Therefore, a simple solution for patients and operators of PD devices is required, which allows to achieve or exceed the minimum sterility limits necessary for medical procedures.

The solution to these technical problems is the provision of a single device that contains all the elements to achieve or exceed sterility standards, which is easy to use and requires little cognitive capacity for proper operation, which is low cost both manufacturing as an acquisition in its final form, and that promotes recycling and optimal use of manufacturing materials.

Users of the OLI type device do not need special training to use it as described.

Users do not have to acquire multiple items to sanitize their homes, clothing, or medical devices for PD.

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.

To better understand the claimed invention, the following figures are provided:

Fig. 1

It is a side view of the way in which all the necessary medical devices are connected at least to perform peritoneal dialysis.

Fig. 2

It is an exploded isometric view of the claimed device in its preferred embodiment.

Fig. 3

It is an exploded side view of the claimed device in its preferred embodiment.

Fig. 4

It is a front view of the claimed device, in which the Cap from which the catheters and pipes are introduced into the sterile chamber is appreciated.

Fig. 5

It is a side view of the claimed device, assembled in its preferred embodiment.

Fig. 6

It is an isometric top perspective view of the claimed device, assembled in its preferred embodiment.

Fig. 7

It is an isometric view in lower perspective of the claimed device, assembled in its preferred embodiment.

Fig. 8

It is a front view of the unassembled sterile chamber, in the modality with extension folds, from which the chamber opening towards the interior of said sterile chamber is appreciated.

Fig. 9

it is a side view of the sterile chamber without assembly, in the modality with extension folds.

Fig. 10

It is an isometric view of the unassembled sterile bedroom, in the modality with extension folds.

Fig. 11

it is a front view of the sterile chamber without assembly, in the mode without extension folds, from which the chamber opening towards the interior of said sterile chamber is appreciated.

Fig. 12

it is a side view of the sterile chamber without assembly, in the mode without extension folds.

Fig. 13

It is an isometric view of the unassembled sterile bedroom, in the No Folds extension mode.

The OLI Device 100 is constituted by at least one sterile chamber 120 and at least one cover 110.

In the preferred embodiment, 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. In the preferred embodiment, sterile chamber 120 is constructed using a soft and translucent polymer. Examples of suitable materials are silicone and latex.

In one embodiment, 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. With this modality, the structural strength of the sterile chamber 120 is not compromised when using little tenacious materials; Thus, a stronger but less stubborn material can be used, the movements of which are aided by the additional mobility provided by Extension Folds 122.

In one embodiment, 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. In another embodiment, the support can be constituted by posts that run at least some portion of the average horizontal Diameter of the chamber 123. In another embodiment, 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. In the preferred embodiment, 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. In one embodiment, the fastener is cement. In another embodiment, the fastener is a heat-generated joint that fuses the body of the sterile chamber 120 into the Cap 110. In another embodiment, 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. In the preferred embodiment, 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. To ensure that when a catheter is introduced to the OLI Device 100 there is a good seal, in the preferred embodiment a Cover Surface 113 is attached to the Cover Cover 112 and another Cover Surface 113 adheres to the Cover Base 111. As shown in Figures 4 and 7, 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. In the preferred embodiment, 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. In the preferred embodiment, the Cover Surfaces 113 are attached to the Cover Base 111 and the Cover Cover 112 with a clamping means. In one embodiment, the fastening means is cement. In another embodiment, the fastener is a heat-generated joint that fuses the Cover Surface 113 with the Cover Base 111 or the Cover Cover 112, respectively. In another embodiment, 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.

In another embodiment, 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. In another embodiment, the Cap 110 is a chuck type of jaws. In another embodiment, the Cap 100 is an endless clamp cover. In another embodiment, the Cover 100 is a quick clamp type clamp.

In the preferred embodiment, 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. In the preferred embodiment, 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. In the preferred embodiment, 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.

In one embodiment, 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.

Having sufficiently described the construction of the claimed device, the manner of operation of the device is also described. In the preferred embodiment, 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. At all times 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.

In other modes, in which the OLI Device 100 has more than two Caps 110, the operator may connect multiple catheters by inserting each into each port or Cap 110. In another mode, in which 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.

IRC: Chronic Renal Failure

DP: Peritoneal Dialysis

LT: Tenckhoff Transfer Line or Catheter

Claims

Device for connecting catheters and pipes, characterized in that it comprises:
A sterile interconnecting chamber of catheters and pipes of a soft and translucent material, with tolerance to compression, extension, and torsion;
At least one inlet port for catheters and pipes that can be closed around them without impeding flow and in the closed position maintain the aseptic state of the sterile interconnecting chamber of catheters and pipes.
The device of claim 1, wherein a disinfection medium is located in at least one inlet port for pipes.
The device of claim 2, wherein at least one fluid trap is placed that decreases or prevents the flow of the disinfection medium into the sterile catheter and pipe interconnecting chamber and towards the outside of the inlet port.
The device of claim 1, wherein the sterile pipe and catheter interconnecting chamber has extension folds.