Applied Sciences

applied
sciences
Article
Biomechanics Perspective for the Design and Manufacture of
Continuous Ambulatory Peritoneal Dialysis Connectors
Mario Alberto Grave-Capistrán 1 , Luis Antonio Aguilar-Pérez 1 , Juan Carlos Paredes-Rojas 2 ,
Carlos De la Cruz-Alejo 3 and Christopher René Torres-SanMiguel 1, *
1 Instituto Politécnico Nacional, Escuela Superior de Ingeniería Mecánica y Eléctrica, Sección de Estudios de
Posgrado e Investigación Unidad Zacatenco, Ciudad de México 07738, Mexico;
mgravec1200@alumno.ipn.mx (M.A.G.-C.); laguilarp@ipn.mx (L.A.A.-P.)
2 Centro Mexicano para la Producción más Limpia, Instituto Politécnico Nacional, Acueducto de Guadalupe
S/N, La laguna Ticomán, CP. 07340, Ciudad de México 07738, Mexico; jparedes@ipn.mx
3 Instituto Politécnico Nacional, Escuela Superior de Ingeniería Mecánica y Eléctrica, Unidad Culhuacán, 04440,
Ciudad de México 07738, Mexico; cdelacruza@ipn.mx
* Correspondence: ctorress@ipn.mx; Tel.: +52-555-729-600 (ext. 54815)
Featured Application: These connectors are used in continuous ambulatory peritoneal emer-
gency dialysis for exchanging different dialysis bags and transfer line brands.
Abstract: Chronic kidney disease (CKD) progressively and irreversibly affects the kidneys and is
considered a catastrophic disease on a global scale. Continuous ambulatory peritoneal dialysis
(CAPD) is one of the most used methods of treatment, involving infusion and draining bags and

a transfer line. Patients receiving this treatment have a catheter that is placed during surgery; this
Citation: Grave-Capistrán, M.A.; depends on having the same catheter supplies, as they are not compatible with other market brands.
Aguilar-Pérez, L.A.; Paredes-Rojas,
This research shows the comparison between connector brands used at the outlet of the Tenckhoff®
J.C.; De la Cruz-Alejo, C.;
catheter. The methodology shows the design of two connectors using the 3D printing technique.
Torres-SanMiguel, C.R. Biomechanics
Numerical simulations were carried out to establish the flow patterns through each of the designs;
Perspective for the Design and
the maximum values of velocity reached 74 mm/s inside the PISA to Baxter (PB) connector, while
Manufacture of Continuous
Ambulatory Peritoneal Dialysis
the pressure and vorticity were controlled and did not represent failures inside the connectors and
Connectors. Appl. Sci. 2021, 11, 1502. threads connections. An experimental testbed was designed to verify the connections between the
https://doi.org/10.3390/ manufactured devices and the market brand elements. The results show numerical and experimental
app11041502 comparisons of the developed titanium-ELI connectors with no leaks at the connection points due to
the lack of commercial supplies. These connectors can be used in the treatment of CAPD.
Academic Editor: Daniel X.B. Chen
Received: 29 November 2020 Keywords: 3D printing; chronic kidney disease; connectors; numerical simulation; testbed
Accepted: 26 January 2021
Published: 7 February 2021
Publisher’s Note: MDPI stays neutral 1. Introduction

with regard to jurisdictional claims in
Chronic kidney disease (CKD) is a degenerative and irreversible chronic disease. The
published maps and institutional affil-
last decade has seen an increased rate in different countries, establishing it as a catastrophic
iations.
disease. Mexico already faces a severe crisis with kidney disease issues, particularly
regarding the economic implications that face the national health industry. Additionally,
the number of patients has exceeded the sector’s capacity [1,2]. CKD is classified according
to the guidelines, Kidney Disease: Improving Global Outcomes (KDIGO) in five phases,
Copyright: © 2021 by the authors.
which are each characterized by their glomerular filtration rate (GFR) as well as their
Licensee MDPI, Basel, Switzerland.
appropriate level of treatment, starting with diagnoses to delay the disease until the
This article is an open access article
beginning reconstructive regressive therapy (RRT). Renal replacement therapies are used
distributed under the terms and
in phase V when the GFR is less than 15/mL/m2 sc [3,4]. The acceptable range for GFR in
conditions of the Creative Commons
men is around 130 mL/min per 1.73 m2 of body surface area and 120 mL/min in women;
Attribution (CC BY) license (https://
creativecommons.org/licenses/by/
nevertheless, there is no set value taking into account the age, gender, and condition of the
4.0/).
patient, although this can be estimated by some mathematical expressions [5].
Appl. Sci. 2021, 11, 1502. https://doi.org/10.3390/app11041502 https://www.mdpi.com/journal/applsci

Appl. Sci. 2021, 11, 1502 2 of 20
In Mexico, the most common renal replacement therapy in medical institutions is

peritoneal dialysis (PD), which has different modalities that use different techniques to
comply with cleansing treatment for the human body. Automated peritoneal dialysis (APD)
is an automatic machine treatment. The replacements are performed in a programmed and
personalized way, allowing the patient freedom during the day since the therapy is carried
out at night in an automatic and scheduled manner. This modality allows the use of a cycler
device so that the patient can perform exchanges at home, heat the dialysate solution, drain
the intra-abdominal cavity, and infuse a certain volume of the liquid. Additionally, it allows
the patient to drain the effluent at a pre-programmed time and to repeat the process for
the number of cycles indicated by their medical instructions. These devices have specific
mechanical and hydraulic systems that effectively aid PD therapy and tightly control
variables such as solution pressure and flow rate. APD has numerous advantages; one of
them is that since the treatment occurs during the patient’s sleep, a greater flow volume can
be perfused, allowing better ultrafiltration with the same residence time as in continuous
ambulatory peritoneal dialysis (CAPD), thus optimizing the number of exchanges. The use
of DPA instead of CAPD is usually indicated in specific situations where the number of
exchanges needs to be increased to achieve a relevant dose of dialysate fluid [6,7].
Continuous ambulatory peritoneal dialysis (CAPD) is the most common renal re-
placement therapy in the world. It is a prescription in which the patient is manually
administered dialysate solution three or four times throughout the day [8]. The treatment
uses system bags for the infusion, permanence, and drainage of liquid, exchanging fluid
through a transfer line between the peritoneal cavity and the human body’s treatment
elements. It is a simple technique with manual daytime replacements in six-hour periods.
Intermittent peritoneal dialysis (IPD) is a technique that is generally performed at the
hospital and requires replacement dialysis infusion bags and intermittent draining with
short-stay dialysate inside the peritoneum. It has a high risk of infection due to the multiple
connections that are used for the treatment [9–11]. In CAPD, the system is connected by
a transfer line with a catheter connecting a bag set that has specific features, according
to the manufacturer. The transfer line is a fundamental piece of equipment that allows
a connection between the peritoneal cavity catheter and the bag set; it can be made of
titanium or plastic and features a protective cap to sterilize the transfer line [12]. It is
essential that the commercial system used to carry out the treatment be followed; regarding
the handling of the components, extreme caution must be taken, and rigorous hygiene
practices must be used to achieve a correct connection between the elements and carry
out the procedure satisfactorily. Substitute therapies for patients suffering from chronic
kidney disease are currently widely accepted, and comply with treatment. There have been
multiple attempts made by different authors to improve these rudimentary peritoneal dial-
ysis systems; numerous types of tubes have been used, such as Foley catheters, catheters
with particular geometries in the tip mushroom and whistle, pipe connectors polyethene
rubber, glass, stainless steel, a double-lumen tube of Rosenak. Most of the connection
systems showed leakage of the liquid and, consequently, infections in the peritoneal cavity.
The first peritoneal dialysis technique performed by nurses was one named “Y” with
a tube-shaped bottle that was no connected to the connector but was connected to the
rudimentary dialysis catheter [13,14]. In the 1970s, plastic bags in the form of a container
began to be used to transport dialysis fluid. Peritoneal dialysis became popular thanks to
continuous ambulatory peritoneal dialysis (CAPD) by Popovich and Moncrief. In these
years, the machines’ operation was rudimentary, although several items were used to
provide infusion and drainage to patients. Meanwhile, CAPD was the preferred dialysis
technique since it did not require prominent investment or lengthy training to understand
the process; it is still used as renal replacement therapy [15].
Nowadays, in Mexico, the Baxter® and PISA® companies are two different brands
dedicated to providing support to connection elements for peritoneal dialysis. Connection
systems for CAPD should ensure the safety of the patient by decreasing the incidence
of infections due unclean handling. The methodology used in this work is based on
Nowadays, in Mexico, the Baxter® and PISA® companies are two different b
dedicated to providing support to connection elements for peritoneal dialysis. Conn
systems for CAPD should ensure the safety of the patient by decreasing the incide
infections due unclean handling. The methodology used in this work is based on
Appl. Sci. 2021, 11, 1502 3 of 20
rology, and we developed a device through preliminary sketches. Through num
simulations, we achieved a detailed design for developing a prototype in order to
its functionality. Finally, prototypes with specific treatment characteristics were
nephrology, and we developed a device through preliminary sketches. Through numerical
oped under medical-grade alloy and subjected to experimental tests. The material
simulations, we achieved a detailed design for developing a prototype in order to verify its
tofunctionality.
carry out the present
Finally, work with
prototypes are classified into three
specific treatment phases. The
characteristics werefirst one involves
developed
the 3D medical-grade
under prototypingalloy technique in acrylonitrile
and subjected butadiene
to experimental styrene used
tests. The materials (ABS) to obtain a
to carry
out the present work are classified into three phases. The first one
studio to establish improvements in the connectors. The second stage consistsinvolves using the 3D of
prototyping technique in acrylonitrile butadiene styrene (ABS) to obtain a visual studio
facturing the detailed design in titanium “Ti-6Al-4V ELI”, which has been used as
to establish improvements in the connectors. The second stage consists of manufacturing
terial in prostheses
the detailed design inand stents
titanium and hasELI”,
“Ti-6Al-4V received acceptance
which has been usedfrom the health
as a material in secto
Finally, in and
prostheses the stents
thirdandstage, an experimental
has received testbed
acceptance from is built
the health sectorto[16].
evaluate
Finally, inthe conn
thread areas
the third inan
stage, equipment
experimental from theisdifferent
testbed brandsthe
built to evaluate already mentioned.
connection thread areas Figure 1
a in equipment
flowchart from the different
considering brands already and
the methodology mentioned.
stages Figure
for the1 shows
designa flowchart
of each connect
considering the methodology and stages for the design of each connector.
Figure 1. Luxury connector diagram for development.

Figure 1. Luxury connector diagram for development.
Our aim is to establish a connection in the systems for CAPD in Mexico, mixing the
Our aim
resources is to establish
to perform a connection
the treatment. in theand
In the materials systems
methodsfor CAPD
section, wein Mexico,
show the mixi
resources to perform the treatment. In the materials and methods section,a we sho
design of the connectors for PD. Using the finite element method (FEM), we generated
virtual model simulation to analyze the fluid behavior through the designed connectors.
design of the connectors for PD. Using the finite element method (FEM), we gener
Nowadays, the 3D printing technique allows one to obtain preliminary prototypes to
virtual
improvemodel simulation
the design in piecesto
inanalyze the fluid
order to obtain behavior
detailed designsthrough the designed
for production. In this conn
Nowadays,
work, 3D modelsthe 3D printing
using technique
ABS material wereallows
used forone to obtain
preliminary preliminary
connection prototypes
tests with
the commercial systems. Once the tests were correctly completed, two prototypes
prove the design in pieces in order to obtain detailed designs for production. In this using
titanium alloy were made to complement the research through an observational study. An
3D models using ABS material were used for preliminary connection tests with the
experimental testbed was developed to verify leaks in each connection thread between the
mercial
Baxter tosystems.
PISA (BP)Once thetotests
and PISA were
Baxter (PB)correctly
connectorscompleted, twolines
with the transfer prototypes
and bag setsusing tit
alloy
from commercial brands; the testbed worked as a support system, providing a means to An e
were made to complement the research through an observational study.
accomplish
mental the connection
testbed medical to
was developed protocol.
verifyThe
leaksresults focus connection
in each on evaluatingthread
the complex
between th
geometries and materials used in PD. The discussions and conclusions
ter to PISA (BP) and PISA to Baxter (PB) connectors with the transfer lines sections discuss an and ba
alternative to performing PD for emergency cases.
from commercial brands; the testbed worked as a support system, providing a me
accomplish the connection medical protocol. The results focus on evaluating the co
geometries and materials used in PD. The discussions and conclusions sections di
alternative to performing PD for emergency cases.
2. Connector Design
Appl. Sci. 2021, 11, 1502 4 of 20
The connectors were designed in a Computer-Aided Design (CAD) prog
modeling in 3D (SolidWorks® student version) and based on the applicable stand
2.threading. A technical sketch was obtained for both connectors, and we estimated
Connector Design
sibility of makingwere
The connectors a successful
designed inconnection between
a Computer-Aided the (CAD)
Design connectors
program andforthe com
Baxter ® and PISA® systems. ® The connectors are the main
modeling in 3D (SolidWorks student version) and based on the applicable standards for element that allows the d
solution from
threading. one brand’s
A technical sketch was bagobtained
to the transfer line of another
for both connectors, and we brand. Eachthe
estimated connecto
possibility of making a successful connection between the connectors
inlet corresponding to the infusion and drainage bags and an outlet correspondin and the commercial
Baxter® and PISA® systems. The connectors are the main element that allows the dialysate
transfer line of each brand, allowing the combination of equipment from two
solution from one brand’s bag to the transfer line of another brand. Each connector has
brands
an to carry outtothe
inlet corresponding theexchange
infusion and of drainage
the fluidbags forandtheanCAPD
outlet treatment
corresponding process. T
nectors’
to development
the transfer line of eachrefers brand,toallowing
industrialthe model designs
combination that havefrom
of equipment theirtwo
use in me
different brands to carry out the exchange of the fluid for the CAPD
specifically in the nephrology’s area, as tool support for the treatment of CAPD. C treatment process.
The connectors’ development refers to industrial model designs that have their use in
ors are characterized by their geometry and ornament, adapting a correct mani
mechanics, specifically in the nephrology’s area, as tool support for the treatment of
with the
CAPD. hands are
Connectors to make a successful
characterized connection
by their geometry andattending the standards
ornament, adapting a correct of Whi
thread giving
manipulation witha the
unique
handspeculiarity that makes
to make a successful the difference
connection attending the and also provides
standards of a
in emergency
Whitworth’s threadcases
giving asa aunique
tool peculiarity
in patients which
that makes need the treatment
the difference avoiding med
and also provides
ageries
solution in emergency cases as a tool in patients which need the
changing the transfer line in use. Figure 2 represents the connection betw treatment avoiding
medical surgeries changing the transfer line in use. Figure 2 represents the connection
connectors developed and the commercial brands for the treatment of CAPD
between the connectors developed and the commercial brands for the treatment of CAPD
human
with body.body.
the human It is noted
It is notedthatthatthetheconnectors
connectors arearethethe
meansmeans to establish
to establish the usethe
of ause of a
of equipment
mixture fromfrom
of equipment different
differentbrands (transfer
brands (transfer line
line andand infusion
infusion and drainage
and drainage bags). bag
Figure
Figure 2. Comparison
2. Comparison of the connectors
of the connectors for the
for the different different brands.
brands.
2.1. BP Connector
2.1.The
BP BP
Connector
connector allows a connection between the Baxter® infusion and drainage
® transfer line, allowing the dialysate fluid to be exchanged to
The
bags and theBP connector
PISA allows a connection between the Baxter® carry infusion
out and d
the treatment. The connector is divided into five main parts:
bags and the PISA transfer line, allowing the dialysate fluid to be exchanged to c
®
1.the An inlet flowThe

connection for Baxter ®
systeminto
bags;five main parts:
treatment. connector is divided
2. A circumference limitation to avoid contamination of the nozzle connection between devices;
3.1. AAn
BP inlet flowmalleability;
connector connection for Baxter® system bags;
4.2. AAcylindrical body
circumference of limitation
the BP connector;
to avoid contamination of the nozzle connection
5. A flow outlet connection for the PISA® transfer line.
devices;
In addition, the geometry and shape are followed by some essential characteristics:
3. A BP connector malleability;
•4. For
A handling: a special finger fastener geometry with a 1 mm round area for handling;
cylindrical body of the BP connector;
• For the fingers: a circular area with a diameter of 28 mm, the thickness of 2 mm,
5. circular
A flow outlet
area at theconnection
top of 1 mm, for
and the PISAarea
a circular
® transfer line.
at the bottom of 0.50 mm;
• A mechanical seal to prevent fluid leakage;
In addition, the geometry and shape are followed by some essential charact
• For handling: a special finger fastener geometry with a 1 mm round area for h
• For the fingers: a circular area with a diameter of 28 mm, the thickness of 2
cular area at the top of 1 mm, and a circular area at the bottom of 0.50 mm;
Appl. Sci. 2021, 11, x FOR PEER REVIEW
Appl. Sci. 2021, 11, 1502 5 of 20

• A mechanical seal to prevent fluid leakage;
• A suitable thread geometry connection for peritoneal Baxter® bags, towards th
• Atransfer line. geometry connection for peritoneal Baxter® bags, towards the PISA®
suitable thread
transfer line.
Figure 3 presents a diagram of the BP connector, showing a horizontal cross-s
Figure 3 presents a diagram of the BP connector, showing a horizontal cross-sectional
isometric
isometric view
view withwith a description
a description of the
of the main main parts.
parts.
Figure
Figure 3. 3. Isometric
Isometric cross-section
cross-section view ofview
the BPof the BP connector.
connector.
2.2. PB Connector
2.2. The
PB Connector
PB connector allows a connection from the infusion and drainage bags of the
PISA® The
system PBtoconnector allows
the transfer line of theaBaxter® system, favoring the exchange of peritoneal
connection from the infusion and drainage bag
fluid
PISA system to the transfer line of the BaxterThis
necessary
® to carry out peritoneal dialysis treatment. connector
® system, has essential
favoring char-
the exchange o
acteristics in terms of its internal conduit and input and output connection. Additionally,
neal fluid necessary to carry out peritoneal dialysis treatment. This connector has
the connector characteristics are divided into five main parts:
characteristics in terms of its internal conduit and input and output connection. A
1. An inlet flow connection for the PISA® bags system;
ally,Circumference
2. the connector characteristics
limitation are divided
to avoid contamination of theinto five
nozzle main parts:
connection between devices;
3. A PB malleability connector;
1. AAn
4.
inlet flow connection for the PISA® bags system;
cylindrical body of the PB connector.
2. ACircumference
5. limitation
flow outlet connection for the to avoid
Baxter contamination
® transfer line. of the nozzle connection
devices; the geometry and ornament have specific characteristics, which are
Additionally,
3. A PB
described malleability connector;
below:
•4. ForA handling:
cylindrical body
special of the
finger PB connector.
fasteners geometry with a chamfer and a 1 mm offset for
5. handling
A flowwith outlet connection for the Baxter® transfer line.
fingers;
• Internal duct reduction from 6.50 to 2.50 mm, through a chamfer of 2 mm with an
Additionally,
inclination of 45◦ ; the geometry and ornament have specific characteristics, whic
•scribed
For the fingers: circular area with a diameter of 28 mm, a thickness of 2 mm, circular
below:
area at the top of 1 mm, and circular area at the bottom of 0.50 mm;
•• AFor handling:
mechanical seal special finger
to avoid fluid fasteners geometry with a chamfer and a 1 mm o
leakage;
• Ahandling fingers; connection of peritoneal PISA® bags to the Baxter® ’s
withgeometry
suitable thread
• transfer
Internalline.duct reduction from 6.50 to 2.50 mm, through a chamfer of 2 mm
Figure 4 shows of
inclination the45°;
technical drawing of the PB connector, shown in an isometric view
and horizontal cross-section, as well as a description of its main parts.
• For the fingers: circular area with a diameter of 28 mm, a thickness of 2 mm,
area at the top of 1 mm, and circular area at the bottom of 0.50 mm;
• A mechanical seal to avoid fluid leakage;
• A suitable thread geometry connection of peritoneal PISA® bags to the B
Appl. Sci. 2021, 11, 1502 6 of 20
The BP and PB connectors are designed to establish a successful connection between

the commercial Baxter® and PISA® systems to favor emergency patient care. Both con-
nectors have a slot in which to place a hermetic mechanical seal (o-ring) and prevent the
leakage of the dialysis solution to ensure the connection between devices is airtight during
the peritoneal dialysis treatment. The connector’s shape geometry allows the correct manip-
ulation of the device to avoid contamination that could cause peritonitis. The material used
for manufacturing the connectors for the experimental tests is titanium “Ti-6Al-4VELI”,
which is used in medical devices and for the CAPD procedure; it can also be subjected to
the cleaning process for reuse in the same treatment.
Figure4.4.Isometric
Figure cross-section
Isometric view ofview
cross-section the PB
ofconnector.
the PB connector.
3. Results
The BP and PB prototypes
Three-dimensional connectors areobtained
were designed toABS
using establish a successful
in the Dimension connection b
SST 1200es
the commercial
printer. Baxter
Table 1 shows
® andfeatures
the printer PISA and
® systems to favor
parameters, emergency
underlining patient
the layer care. Both c
resolution
ors have
used a slot
was 254 in which to place a hermetic mechanical seal (o-ring) and prevent t
microns.
Three-dimensional models to
age of the dialysis solution support
ensurethethe
connection
connectiontestsbetween
carried out under is
devices visual
airtight du
examination and allow us to establish each developed connector’s correct functionality.
peritoneal dialysis treatment. The connector’s shape geometry allows the correct
The connection between these prototypes and the commercial devices used a detailed
ulation
design of thethat
to ensure device to avoid
the thread contamination
connection and geometrythat
were could
accuratecause peritonitis.
for each connector. The m
used for manufacturing
Additionally, 3D models in ABS thewere
connectors for
essential, as theallowed
they experimental tests is
a visual analysis of titanium
the
strategical manipulation in the medical sector, specifically in CAPD.
4VELI”, which is used in medical devices and for the CAPD procedure; it can Then, numerical
simulations we performed considering the material properties. Figure 5 shows BP and PB
subjected to the cleaning process for reuse in the same treatment.
connectors in ABS material made by a 3D printer.
3. Results
Three-dimensional prototypes were obtained using ABS in the Dimension SST
printer. Table 1 shows the printer features and parameters, underlining the layer
tion used was 254 microns.
Table 1. Dimensions of the SST 1200es printer.
Brand Stratasys
Machine type 3D Printer
Technology FDM (fused-deposition modeling)
Appl. Sci. 2021, 11, 1502 7 of 20
Table 1. Dimensions of the SST 1200es printer.
Brand Stratasys
Machine type 3D Printer
Technology FDM (fused-deposition modeling)
Appl. Sci. 2021, 11, x FOR PEER REVIEW ABSplus in ivory, white, black, red, green, olive, nectarine,
Material modeling
fluorescent yellow, blue, or gray
Support material Soluble support technology or breakaway support technology
Build volume 254 × 254 × 305 mm (10 × 10 × 12 in.)
connection between these prototypes and the commercial devices used a detaile
Layer resolution low: 330 microns (0.013 in.)
Layer thickness
to ensure that the thread connection and geometry were accurate for each connec
Layer resolution high: 254 microns (0.010 in.)
ditionally, 3D models in ABS were essential, as they allowed a visual analysis of
Dimensions and weight 33 × 29 × 45 in and 326 lbs.
tegical manipulation in the medical sector, specifically in CAPD. Then, numerica
Regulatory compliance CE/ETL
tions we performed considering the material properties. Figure 5 shows BP and
Approximately cost 32.900 USD
nectors in ABS material made by a 3D printer.
Figure
Figure 5. 5. Acrylonitrile
Acrylonitrile butadiene
butadiene styrene
styrene (ABS) (ABS)model:
connector connector
(a) BP model: (a) BP plastic
plastic connector connector
and (b) PB
PB plastic
plastic connector.
connector.
Subsequently, the performance of the designs was evaluated by numerical analyses of

Subsequently, the performance of the designs was evaluated by numerical
the behavior of the fluid through BP and PB connectors under two study scenarios:
of the
1.
behavior of the fluid through BP and PB connectors under two study scena
Fluid dynamic computational analysis in BP connector;
2.
1. Fluid dynamic
Fluid computational
dynamic analysisanalysis
computational in PB connector.
in BP connector;
2. The connectors
Fluid dynamicwerecomputational
manufactured in titanium,
analysisand the connector.
in PB comparison was verified for
the commercial brands. An experimental testbed was developed for the connectors to
test whether the linking connections
The connectors between theindevices
were manufactured was airtightness.
titanium, Equipmentwas ver
and the comparison
was
the commercial brands. An experimental testbed was developed fluid
used for detecting high leakage luminescence; there was no output of the at the
for the connecto
connection between the BP and PB connectors and the commercial devices at the inlet
whether
and theflow
the outlet linking connections
connections where the between theThe
fluid flows. devices wassection
following airtightness.
is dividedEquipm
used
by for detecting
subheadings. high
It should leakage
provide luminescence;
a concise and precisethere was no
description output
of the of the fluid at
experimental
nection between the BP and PB connectors and the commercial devices at the inle
results, their interpretation, as well as the experimental conclusions that can be drawn.
outlet flow connections where the fluid flows. The following section is divided
headings. It should provide a concise and precise description of the experimenta
their interpretation, as well as the experimental conclusions that can be drawn.
3.1. Fluid Computational Dynamics

Appl. Sci. 2021, 11, 1502 8 of 20
3.1. Fluid Computational Dynamics

Table 2. connectors
The Boundary were
conditions for to
subjected numerical
numerical simulation in the Solidworks® student
simulation.
version to simulate the fluid’s path through the internal conduit. The boundary conditions
Boundary
are described in Table 2. The infusion liquid Conditions
speed to the human body, and drainage of the
dialysate solution from the human
Connector Material body are reported [17]. Furthermore,Plastic
intraabdominal
(PET)
pressure was present during the treatment process [18].
Fluid Saltwater
m
Gravity
Table 2. Boundary conditions for numerical simulation. 9.81
s
Boundary Conditions ml
Infusion flow 3.3333
Connector Material Plastic (PET) s
ml
Fluid
Drain flow Saltwater 1.6666
Gravity 9.81 ms2 s
Intraabdominal
Infusion flow pressure 3.3333 mL s 5 mmHg
Drain flow 1.6666 mL
Temperature flow
Intraabdominal pressure 5 mmHg
s 37.5 °C
Temperature flow 37.5 ◦ C
The flow starts with laminar behavior, but this becomes turbulent and signi
The flow starts with laminar behavior, but this becomes turbulent and significantly
affects thefluid
affects the fluid due
due to the
to the pipe’s
pipe’s boundary
boundary layer. layer.
Figure Figure
6 shows6theshows the BP connecto
BP connector’s
nection
connectionpoints
pointswith thecommercial
with the commercial elements
elements and shows
and shows thefeatures.
the thread thread features.
Figure
Figure 6.6.
BPBP connector,
connector, join points,
join points, andfeatures.
and thread thread features.
On the other hand, from the PISA bags connected to the Baxter transfer line, the PB
On the other hand, from the PISA bags connected to the Baxter transfer line
connector was suitable for accomplishing the connection. Figure 7 shows a sketch of the
connector was suitable
connection points and threadfor accomplishing the connection. Figure 7 shows a sketc
features.
connection points and thread features.
3.2. BP Connector in the Infusion Process
The length of the perfusion procedure from the bag with a dialysate solution to
the human body is approximately 10 min. Table 3 shows the infusion parameters and
numerical analysis of the fluid process in the BP connector.
It is observed that are no drawbacks when the fluid passes through the internal duct of
this connector. Additionally, no vortices are generated in the flow. The speed profiles and
pressure through the connector are acceptable to carry out a fluid exchange as is performed
in the treatment of CAPD.
Appl. Sci. 2021, 11, x FOR PEER REVIEW 9 of 21
Appl.
Appl. Sci.
Sci. 2021,
2021, 11,
11, x
x FOR
FOR PEER
PEER REVIEW
REVIEW 99 of
of 21
21
Appl.
Appl.Sci. 2021,
Sci. 11,11,
2021, 1502
x FOR PEER REVIEW 9 of 2021
9 of
Figure 7. PB connector, join points, and thread features.

Figure
Figure 7.
7. PB
PB connector,
connector, join
join points,
points, and
and thread
thread features.
features.
3.2. BP Connector in the Infusion Process
3.2.
3.2. BP
BP
TheConnector
length ofin
Connector the
inthe Infusion
Infusion Process
the perfusionProcess
procedure from the bag with a dialysate solution to the
Figure7.7.PB
Figure human The
PBconnector,
connector,length
body
The length is of the
joinpoints,
join points,
of perfusion
approximately 10
andthread
the and thread
perfusion procedure
min. Table from
features.
procedure
features. from the
3 shows bag
the the with
with aa dialysate
baginfusion parameters
dialysate solution to
to the
and numer-
solution the
human
ical body
analysis is
of approximately
the fluid process10 min.
in the Table
BP 3 shows
connector. the infusion parameters
human body is approximately 10 min. Table 3 shows the infusion parameters and numer- and numer-
ical
ical analysis
3.2. BP Connector in theof
analysis the
the fluid
ofInfusion process
process in
fluidProcess in the
the BP
BP connector.
connector.
Table 3. Flow,Table 3. Flow,
pressure, andpressure, and
vorticity vorticity numerical
numerical analysis
analysis for for BP connector—infusion
BP connector—infusion fluid process.
fluid process.
The length
Table ofFlow,
Table 3.
the pressure,
3. Flow,
perfusion
pressure, and
procedure
and vorticity
from the
vorticity numerical
bagfor
numerical analysis
with
analysis for BP a dialysate solution
BP connector—infusion
connector—infusion fluid
to the
fluid process.
process.
human body is approximately 10BP Connector—Infusion
min. Table 3 shows the Fluid Process
infusion parameters and numer-
BP Connector—Infusion Fluid Process
Parameters BP Connector—Infusion
BPthe
Connector—Infusion Fluid Process
Numerical
Fluid ProcessAnalysis
ical analysis of the fluid process in BP connector.
Parameters
Parameters
Parameters Numerical Analysis
Numerical
Numerical Analysis
Analysis
Table 3. Flow, pressure, and vorticity numerical analysis for BP connector—infusion fluid process.
Flow (mm/s): simulation of BP con-
Flow
Flow (mm/s):
nector flowssimulation
(mm/s): evaluating
simulation of BP
BP con-
velocity
of con-
BPBPConnector—Infusion Fluid Process
Flow (mm/s): simulation
nector flows of connector
evaluating flows
velocity
profiles
nector starting
flows around
evaluating 3 mm/s and
velocity
Parameters
evaluating velocity profiles starting around 3 Numerical Analysis
profiles
profiles at 1.880380
ending starting × 10
around 33 −mm/s and
mm/s.
mm/s and endingstarting around
at 1.880380 × 10 mm/s and
3 mm/s.
ending at 1.880380
ending at 1.880380 × × 10
10 mm/s.mm/s.
Flow (mm/s): simulation of BP con-
Pressure
nector flows (MPa): pressure
evaluating velocitywas eval-
Pressure
Pressure
profiles starting (MPa):
uated around
in the
(MPa):3 pressure
same was
connector
pressure
mm/s eval-
waswhen
and eval-
uated
the in
fluidthe same
moved connector
from when
ending uated
1.880380
Pressureat(MPa): in the same
× 10
pressure mm/s. inofthe
the
connector
was evaluatedset
when
same connector the
bags
thewhenfluid
intothe
fluid moved
the
moved transfer
fluid from
fromline;
moved the
the set
set of
results
from of
the set
of bags intoare bags
bags into
into the
theclosest
transfer the transfer
between
transfer
line; resultsline;
0.000741
line;
are results
MPa
results
closest
between are closest
0.000741
are closestandMPa between
0.000757 0.000741
and 0.000757
between MPa. MPa.
0.000741 MPa
MPa
Pressure (MPa): pressure and
and 0.000757
0.000757was MPa. eval-
MPa.
Vorticity (s ): the vorticity gener-
uated in the same connector when
Vorticity
ated when(s (sthe): the
):fluid vorticity
is movedgener- from
Vorticity
the fluid (s−Vorticity
1 ): the
moved vorticity
from
the
the
vorticity
generated
set of when
gener- the
Appl. Sci. 2021, 11, x FOR PEER REVIEWated
ated the when
inlet
when the
flow
the fluid is
connection
fluid moved
moved from
is connection and
from 10 of 21
fluid is moved
bags into thethe from the
transfer inlet
line; flow
results and
drained to the drained the inlet
transferinletto flow
the
flow
line thatconnection
transfer
connection
reaches linetheand
that
and human
are
body closest
was alsobetween
drained
reaches
drained the
analyzed. to0.000741
to the
human
theIt istransferMPa
body
transfer
observed line
was
line that
also
that
that the
fluid rotationandreaches
0.000757
analyzed.
changes
reaches
this point theat ItMPa.
human
is
the
theishuman body
observed
connection
null in body was
was also
that
the numerical the
point,
alsobut
the behaviorfluid shows
analyzed.
analyzed. values
rotation It
It is that do at
observed
ischanges
observed
simulation. not
that
thegenerate
that the
con-
the
Vorticity (sNumerical
complications, ):
so
fluid
nection
fluid the
the vorticity
fluid
rotation
point,
rotation leak
changes gener-
at thisat
but theresults
changes
simulation point
the
behavior
at ofisBP
con-
the con- null
ated when inshows
the
the numerical
fluid
nection is
point,
values movedsimulation.
thatbut the
dothe from
not behavior
generate
nection
connector point,
show but
adequate behavior
fluid be-
Numerical shows
the inlethavior
simulation
shows values
flow connection
complications,
values
that does that
sonot
results
that do
and
the
of
do not
fluid
BP
not
present generate
leak
connector
generate
a riskat
show adequate
drained to
to the fluid
complications,
complications,
carryingtransfer behavior
out so
so
line
the the
the that
fluid
fluid
that
fluid doesleaknot
leak
exchange. at
at
present a risk to carrying out the fluid exchange.
reaches theThe humanpressure body andwas vorticity
also remain
The pressure and vorticity remain stable, and it is
analyzed. stable, and it is that ensured the that the
ensured thatIttheis observed
fluid profiles during infusion
fluid rotation fluid profiles
changes during
at thewithoutinfusion
con- affecting be-
behave in a controlled manner
the procedure have in a controlled
of treatment. manner
We can also observe with-
nection point, but the behavior
out affecting
the flow profiles at the the linkingprocedure
point with of treat-
the
shows values ment.
that
We
do
can
not
also
generate
observe the flow
transfer trademark line.
complications,profilessoatthe the fluid
linking leakpoint at with the
It is observed that are no drawbacks when the fluid passes through the internal duct
of this connector. Additionally, no vortices are generated in the flow. The speed profiles
and pressure through the connector are acceptable to carry out a fluid exchange as is per-
ment. We
ment. We can
can also
also observe
observe the
the flow
flow
profiles at
profiles at the
the linking
linking point
point with
with the
the
transfer trademark
line.
Appl. Sci. 2021, 11, 1502

It is
It is observed
observed that
that are
are no
no drawbacks
drawbacks when
when the
the fluid
fluid passes
passes through
through the
the internal
internal duct
10 ofduct
20
and pressure
and pressure through
through the
the connector
connector are
are acceptable
acceptable to
to carry
carry out
out aa fluid
fluid exchange
exchange as
as is
is per-
per-
formed in the treatment of CAPD.
formed in the treatment of CAPD.
3.3. BP Connector in the Draining Process
3.3. BP
3.3. BP Connector
Connector in
in the
the Draining
Draining Process
Process
After the dialysis liquid is perfused into the peritoneal cavity, it remains within the
After the
After the dialysis
dialysis liquid
liquid isis perfused
perfused into
into the
the peritoneal
peritoneal cavity,
cavity, it
it remains
remains within
within the
the
human body for
human
approximately
body for
20 min,
approximately 20
performing
min,
a cleaning
performing a
process
cleaning
in the
process in
peritoneal
the peritoneal
human body for approximately 20 min, performing a cleaning process in the peritoneal
cavity. When theWhen
cavity. cleaning process process
the cleaning
cleaning is completed, the draining
is completed,
completed, procedure
the draining
draining begins
procedure and
begins lasts
and lasts
cavity. When the process is the procedure begins and lasts
approximately 20 min;
approximately 20
approximately
thus, the
20 min; flow
min; thus, of
thus, the the
the flow discarded
flow of
of the liquid
the discarded is
discarded liquidless
liquid is compared
is less
less comparedto
compared tothat which
to that
that which
which
enters. Table 4 shows
enters.
enters. Table the
Table fluidthe
44 shows
shows draining
the processprocess
fluid draining
fluid draining results.
process results.
results.
Table
Table 4. Flow, 4. Flow,
Flow,and
pressure,
Table 4. pressure, and numerical
vorticity
pressure, and vorticity numerical
vorticity numerical analysis
analysisanalysis for
for BP for BP connector—
connector—
connector—
BP fluid
fluidfluid draining
draining pro-
process.
draining pro-
cess.
cess.
BP Connector—Drain Fluid Process
BP Connector—Drain
BP Connector—Drain Fluid
Fluid Process
Process
Parameters
Parameters
Parameters Numerical
Numerical Analysis
Analysis
Numerical Analysis
Flow (mm/s):
Flow (mm/s): flowflow draining
draining behavior
behavior
Flow (mm/s): intoflow
into the bag
the bag to store
to
draining store the discarded
the discarded
behavior liq-
into theliq-
bag
uid.
to store the uid. The flow
The
discarded flow begins
begins
liquid. with
Thewith
flowa abegins
constant
constant
with
speed,
a constantspeed, and
speed,and
andatatatthe
the moment
themoment
momentit ititcrosses
crosses the
crossesthethe
connection point, the
connection
connection speed
point,
point, theprofiles
the increasein-
speed profiles
speed profiles in-
towards
creasethe
crease link with
towards
towards the the
the linkbag
link with
with set.
the bag
the bag
set.
set.
Pressure (MPa):
Pressure (MPa): the the results
results of of numeri-
numeri-
Pressure
Appl. Sci. 2021, 11, x FOR PEER REVIEW cal (MPa):
simulation the results
of the
cal simulation of the conduit pressure of numerical
conduit pressure 11 of 21
simulation Vorticity
are ofnegative (s and
the conduit
negative ): the vorticity
pressure
tend arevalues
to increase
increase negative
when in-
are and tend to when
and tend to crease
increase
the flowwhen when
goes the liquid
the flow
through in the
the drainage
to goes through
BP con-
the flow goes through to the BP con-
stageto the BPthe
reaches connector.
linking
nector. point with the
Vorticity nector.
(s connector.
): the vorticity
BP coupling Thisvalues
behavior in-
crease
is duewhen to thethe liquid ininthe
difference drainage
geometries
stage
between
− 1 reaches
the the linkingconnectors
developed point withand the
Vorticity (s ): the vorticity values increase when
BP
the coupling
transfer connector.
line of the This behavior
trademark. At
the liquid in the drainage stage reaches the linking
is due
the
point with theto
linkingBPthe difference
point,
coupling BPin
theconnector. geometries
connector Thishas
between
behavioraisrounddue toareathe developed
the towards
difference connectors
theininternal
geometries and
con-
between thethe transfer
developed line of
connectors the
duit; this was designed to help the trademark.
and the At
transfer
line of the the linking
trademark. point,
At the the BP
linking
fluid enter. The human body does not connector
point, the hasBP
connectorahas round a round
area area
towards towards
generate the uncontrolled fluid rota- the the
internal internal
con-
conduit; thisduit;was thisdesigneddesigned to help the help fluid enter.
tion ofwas the draining to liquid. the
The human body does
fluid enter. The human body does not generate the not
uncontrolled fluid rotation of the draining liquid.
generateinthe
Changes theuncontrolled
flow profilesfluid rota-
are admis-
tion of the draining liquid.
Changessible in the because there isare
flow profiles a controlled
admissiblein-
because there crease in the linking
is a controlled increasebags;inthe themaxi-
linking
bags; theChanges
mummaximum value in the flow
increases
value profiles
due todue
increases are to
the admis-
change
the
change inin sible
the because
thegeometry
geometry there
ofofthe is ducts.
the aducts.
controlled
The
Theflow in-
flow
crease
values are stable
valueswithoutin the
are stable linking
leaks bags;
in theleaks
without the maxi-
connections;
in the
this avoids
mum pathology
value increases
connections; risk,
thissuch due
avoids astopathology
peritonitis.
the change
in the geometry
risk, suchofasthe ducts. The flow
peritonitis.
values are stable without leaks in the
The connector’s linking point produced a flow change and increased it, letting the
connections;
The connector’s this avoids linking pathology
point produced a flow change and increased it, letting the
draining occur in risk, a short such
time. At the point of linking between the elements, the speed of
draining occur in aasshortperitonitis.
time. At the point of linking between the elements, the speed of
the fluid increases, favoring the treatment since it aims to reduce the time in which the
liquid is discarded. The
liquid is discarded.This willThis
connector’s speed willup
linking theproduced
point
speed completion
up of change
a flow
the completion theoftreatment
theand andand
increased
treatment provide
it,providethe
letting the
patient freedompatientto
draining carryin
occur
freedom out theirout
toa carry
short daily
time. Atactivities.
their the
daily point of linking between the elements, the speed of
activities.
3.4. PB Connector
liquid indiscarded.
3.4. PBisConnector the Infusion in theThis Process
Infusion
will speed Process up the completion of the treatment and provide the
A PB patient
connector freedom to
numerical carry
A PB connector numerical simulationout their
simulation daily activities.
was performed
was performed under thethesame
under sameborder
border con-
condi-
ditions; it tions;
is essential to point
it is essential out that
to point out there is a isreduction
that there inin
a reduction thetheinternal
internal conduit. There-
conduit. The
3.4. PB
duction Connector
is from in
an the Infusion
internal Process
diameter of 6.50 to 2.50 mm; this reduction
reduction is from an internal diameter of 6.50 to 2.50 mm; this reduction is required to link is required to link
A PB connector
the outlet numerical
flow connection simulation
to the was performed
Baxter® transfer line. Theunder the same
infusion border
process condi-
for the PB
tions; it is is
connector essential
shown to point 5.
in Table out that there is a reduction in the internal conduit. The re-
duction is from an internal diameter of 6.50 to 2.50 mm; this reduction is required to link
Table
the 5. Flow,
outlet flowpressure, and vorticity
connection to the numerical analysisline.
Baxter® transfer for PBThe
connector—infusion
infusion processfluid
for process.
the PB
connector is shown in Table 5.
PB Connector—Infusion Fluid Process
liquid is discarded. This will speed up the completion of the treatment and provide the
patient freedom to carry out their daily activities.
3.4. PB Connector in the Infusion Process

Appl. Sci. 2021, 11, 1502 11 of 20
A PB connector numerical simulation was performed under the same border condi-
tions; it is essential to point out that there is a reduction in the internal conduit. The re-
duction is from an internal diameter of 6.50 to 2.50 mm; this reduction is required to link
the the
outlet flow connection to the Baxter ® transfer line.line.
TheThe
infusion process for for
the the
PB PB
outlet flow connection to the Baxter ® transfer infusion process
connector is shown
connector in Table
is shown 5. 5.
in Table
Table 5. Flow,
Table pressure,
5. Flow, and and
pressure, vorticity numerical
vorticity analysis
numerical for PB
analysis forconnector—infusion fluidfluid
PB connector—infusion process.
process.
PB
PBConnector—Infusion
Connector—InfusionFluidFluid
Process
Process
Parameters
Numerical Analysis
Flow (mm/s): fluid behavior increases
Appl. Sci. 2021, 11, x FOR PEER REVIEW from 1.0 × 10 to 4.496 × 10 12 of 21
Flow (mm/s): fluid behavior increases from
mm/s
× 10−7intothe
1.0Pressure (MPa):
4.496 last×pressure
part
10−1 of mm/sthe linking
results
in thein last
Appl. Sci. 2021, 11, x FOR PEER REVIEW part point.
this theThe
of connectorlinking ductpoint.neckThe
decreasing increases
ductfrom neck 12 of 21
increases
through throughthe the reduction
reduction to 6 tomm/s
6 mm/s
0.00416
Pressure MP (MPa):at thepressure
bag linking results input in
when when thethe liquid liquid is in isthe in perfusion
the perfusionprocess.
tothis
0.000634
connector MPa decreasing
at the commercial from
Pressure (MPa): process.
transferMP
0.00416 line thepressure
atoutput. bagThe results
duct
linking pres-
input in
sure this connector
presenting the
to 0.000634 MPa at the commercial decreasing
reduction fromis con-
Pressure (MPa): pressure results in this
0.00416
stant atMP
transfer lineatoutput.
0.000583 theMPa bag linking
andduct does inputnot
connector decreasing fromThe 0.00416 MPpres- at the
to
sure 0.000634
represent
presenting
bag linking MPa
fluid
input the at the
transfer
reduction
to 0.000634 commercial
complica-
MPaisatcon- the
transfer
commercial
stant at 0.000583line output.
transfer tions.lineThe
MPa output.
and duct
doesThepres- duct
not
pressure
sure
Vorticity presenting
presenting
represent (s fluid the
): thethe reduction
reduction
vorticity
transfer is constant
is con- at
connector
complica-
0.000583 MPa
stant at 0.000583 and does not represent fluid
behavior changes MPa whenand does not
it reaches the
transfer tions. complications.
represent
conical reduction;
Vorticity fluid transfer
(s ): the vorticity it presents complica- a con-
connector
siderable
behavior changes when it reachess the
increase tions. up to 153.80 ,
Vorticity
Vorticity
and when(s−1(s):itthe ): vorticity
the
through vorticity
intoconnector
the connectorbehavior
conduit,
conical reduction; it presents a con-
changes when it reaches the conical reduction;
behavior
itsiderable
decreases changes balancing when it153.80
the reaches
fluid rota- the
it presents a considerable increase upincrease
to up tos 153.80 ,
−
sandconical
tion
1 until
when
, and reduction;
when it reaches
it through
it throughintoit presents
the link
intothe a
with
the conduit,con-the
conduit, it
siderable
decreases
it decreases increase
balancing transfer
balancingtheup fluidto
line.
the 153.80
rotation
fluid rota- suntil , it
and reaches
when the
it link with the transfer line.
Flow
tion profiles
until it throughobtained
reaches intolink
the the with
during conduit,
infu-
the
itsion
decreases balancing
in the transfer
PB connector line.the fluid
show rota-
that
Flow theprofiles
tion until
profiles itobtained
reaches
change during
the
when link infusion
itwith
reaches in the
the
Flow profiles obtained during infu-
PB connector show that the profiles change
when
the
sion in the transfer
conical
it reaches
reduction;
PB
the connector
conical
line. it isshow
reduction;
seen that that
it is seen
thatFlow speed
thespeed profiles
profiles increases. obtained
change
increases. When
When when during
the
theitfluid infu-
fluid
reaches passes
sion
passes
through
the in the
conicalthereduced
through PB connector
theduct,
reduction; ititisshow
reduced seenduct,
regulates that
that it
the
velocity
the
regulates with
profiles the achange
constant
velocity whenvalue
with towards
ita reaches
constant the
speed increases. When the fluid
commercial
the conical transfer
reduction; line; the it isperfusing
seentrans- that flow
value
passes towards
through thethecommercial
reduced
will maintain in a permanent stateduct,untilitthe
fer speed
line; the
regulates increases.
theperfusing
velocity
liquid When
drains.flowthe
with awillfluidmain-
constant
passes
tain in a through
permanent
value towards the commercial trans-the reduced
state until duct,
the it
liq-
3.5.regulates
PBline;
fer Connector
the theperfusing
velocity
uid
in the drains. with
flow awill
Draining constant
Process
main-
value
tainAs in towards
a permanent
already the
mentioned, commercial
statethe until trans-
the liq-process takes approximately 20 min, so the flow
draining
tends 3.5.to
fer PB
line;beConnector
the
slower perfusing
uidthan in the
drains. Draining
flow
the will main-
infusion Process
process. The reduction inside this connector allows
tain in
increasing Asathe permanent
alreadyflow through statethe
mentioned, until thethe
reduced liq-duct,process
draining favoringtakes approximately
the draining 20Table
process. min, 6soshows
the flow
tends
the3.5.results to be uid
slower
for this stage.
PB Connector drains.
than the
in the Draining Process infusion process. The reduction inside this connector allows
increasing
TheAs flow already the flow
behavior, throughthe
pressure,
mentioned, the
and reduced
vorticity
draining duct,
are
process favoring
explicit
takes in theconnectors;
both draining
approximately 20 process. Table
thesesoresults
min, the flow6
favor3.5.
shows PB Connector
the
continuing results with inforthe
the Draining
this stage.
methodology Process proposed.
tends to be slower than the infusion process. The reduction inside this connector allows Table 7 presents the numerical simula-
tionincreasing
behavior
As already value
the flow during
mentioned,throughthe infusion
thethe draining process
reduced into the
process
duct, takesconnectors, comparing
approximately
favoring the draining thesoresults
20 process.
min, the flow6
Table
from Table
tends the 6. Flow,
inlet flow pressure,
connection and vorticity
(system numerical
bags) to analysis
the for
outlet PB
flow connector—fluid
connection draining
(transfer pro-
line).
showstothe beresults
slowerfor than thisthe infusion process. The reduction inside this connector
stage. allows
cess.
increasing the flow through the reduced duct, favoring the draining process. Table 6
shows
Table 6.the Flow, results for this
pressure, andstage.vorticity
PB numerical analysis
Connector—Drain for PB
Fluid connector—fluid draining pro-
Process
cess. Parameters Numerical Analysis
Table 6. Flow, pressure, and vorticity numerical analysis for PB connector—fluid draining pro-
Flow (mm/s): flow behavior PBduring
Connector—Drainthe Fluid Process
cess.
draining process receives
Parameters a gradual in- Numerical Analysis
Flow crease (mm/s):in theflow profiles,behavior and PBalthough
Connector—Drain
during the Fluid Process
only a reduction
draining process Parameters
occurs,
receivesthis allows in-
a gradual an Numerical Analysis
Flowincrease
crease (mm/s):ininthe the flowspeed behavior
profiles, ofand duringthe
emptying
although the
draining
only a reduction occurs, this allows in-
peritoneal process
fluid receives
from the a gradual
transfer line.an
crease
Numerical
increase ininthe profiles,
speed ofand
thesimulation although
shows
emptying thethe
3.5. PB Connector in the Draining Process
As already mentioned, the draining process takes approximately 20 min, so the flow
tends to be slower than the infusion process. The reduction inside this connector allows
increasing the flow through the reduced duct, favoring the draining process. Table 6
shows the results for this stage.
Appl. Sci. 2021, 11, 1502 12 of 20
Table 6. Flow, pressure, and vorticity numerical analysis for PB connector—fluid draining pro-
cess.
Table 6. Flow, pressure, and vorticity numerical analysis for PB connector—fluid draining process.
PB Connector—Drain Fluid Process
Parameters PB Connector—Drain Fluid Process
Numerical Analysis
Flow (mm/s): flow behavior during the
draining process receives a gradual in-
Flow (mm/s):
crease flow behavior
in the profiles, during the
and although
draining process receives a gradual increase in
only a reduction
the profiles, occurs, only
and although this allows an
a reduction
increase in the speed of emptying
occurs, this allows an increase in the speed of the
emptying
peritoneal thefluid
peritoneal
fromfluid from the line.
the transfer transfer 13 of 21
line.Numerical
Numerical simulation
simulation shows
showsthe fluid’s
the
behavior when the waste liquid is drained
fluid’s behavior when the waste liquid
from the corresponding bag’s transfer line.
is drained from the corresponding
Pressure (MPa):
Pressurebag’s
(MPa): pressure
line.presents
pressure
transfer presents aa
change, starting
change,(MPa):
starting with a high-pressure
with apresents
high-pressure
Pressure pressure a change,
that
that decreases
starting when
when itit crosses
with a high-pressure
decreases the
the PB
that decreases
crosses PB
connector
connector reduction, reaching the bag
when it reduction,
crosses the PB reaching
connector the
reduction,
bag
reaching
assembly’s the bag assembly’s
connection andconnection
specificallyand
assembly’s connection
specifically the drainand specifically
connection.
the
the drain
drain connection.
connection.
Vorticity
Vorticity (s(s ):): fluid
fluid rotation
rotation in in the
the
connector
connector presents a change at the
the re-
Vorticity (s−1presents a change
): fluid rotation in theatconnector
re-
duction,
duction,
presents
increasing
increasing
a change
values
at the values
reduction,
till 138.80
tillincreasing
138.80
ss ..till
values However,
138.80 s−once
However, it
it crosses
1 . However,
once oncethe
crosses re-
it crosses
the re-
duced
the duct,
reduced
duced it
it returns
duct,duct, it returns
returns to the
to to
thethestable
stableand
stable and
and
continuous
continuous behavior
behaviorthat itthat
initially
it presents.
initially
continuous behavior that it initially
presents.
presents.
Flow
Flow profiles
profiles in
in the
the draining
draining process
process
Flow
are profiles
acceptable,in the
speeddraining process
increases in are
are acceptable, speed increases in the
acceptable, speed increases in the conical the
conical
conical reduction
reduction and
and it is
is constant
itbehaviour
constant be-
be-
reduction and it is constant through
haviour
the through
connector. The the connector.
haviour through the connector. The
profiles increase The
with
profiles
profiles increase
maximum with
with maximum
speed movement
increase speed
at the reduction.
maximum speed
movement at the reduction.
movement at the reduction.
Table 7.The
The flow
Flow, behavior,
pressure,
flow and pressure,
behavior, and
and vorticity
vorticity behavior
pressure, of the are
vorticity fluidexplicit
are in
in both
in the BP
explicit connectors;
and PB
both connectorsthese
connectors; in there-
these re-
sults
infusion favor continuing
process.
sults favor with the methodology proposed. Table 7 presents the
continuing with the methodology proposed. Table 7 presents the numerical numerical
simulation behavior
simulation behavior value
value during
during the
the infusion
infusion process
process into
into the
the connectors,
connectors, comparing
comparing the the
Infusion Fluid Process
results
results from
from the
the inlet
inlet flow
flow connection
connection (system
(system bags)
bags) toto the
the outlet
outlet flow
flow connection
connection (transfer
(transfer
line). Flow (mm/s) Pressure (MPa) Vorticity (s−1 )
line).
Outlet Outlet
Parameters INLET Outlet
Table Transfer behavior
Inlet Bagthe fluid in the BP andInlet Bag Transfer
Table 7.
7. Flow,
Flow, pressure,
BAG
pressure, and
and vorticity
vorticity
Line behavior of Transfer
of the fluid LineBP and PB
in the PB connectors in
in the
connectorsLinethe in-
in-
fusion process.
fusion process.
BP
3 1.605 × 10−3 0.0009 0.0005 41.19 3.22
connector Infusion
Infusion Fluid
Fluid Process
Process
PB Flow
Flow
1.650 × 10
(mm/s)
−(mm/s)
6 6
Pressure
Pressure
0.000416
(MPa)
1.608 × 10−12
(MPa) Vorticity
Vorticity (( 0.97
0.08
))
Parame-
connector
Parame- INLET Outlet Transfer Inlet Outlet Transfer
ters INLET Outlet Transfer Inlet Outlet Transfer Inlet Bag Outlet Outlet Transfer
Transfer
ters BAG Line Bag Line Inlet Bag Line
BAG Line Bag Line
Table 8 presents the results obtained from the fluid drainage process numerical sim- Line
BP
BP con-
ulation through
con- 33 the BP
1.605 and PB
1.605 × × 10
10
connectors;
0.0009
0.0009
the results
0.0005
0.0005
are classified
41.19
41.19
from the peritoneal
3.22
3.22
nector
cavity’s inlet flow to the bag set’s outlet flow connection.
nector
con- 1.650
PB con- 0.00041
PB 1.650 0.00041 1.608
nector × 10
66
66 1.608 ×× 10
10 0.08
0.08 0.97
0.97
nector × 10
Table
Table 88 presents
presents the
the results
results obtained
obtained from
from the
the fluid
fluid drainage
drainage process
process numerical
numerical sim-
sim-
ulation
ulation through
through the
the BP
BP and
and PB
PB connectors;
connectors; the
the results
results are
are classified
classified from
from the
the peritoneal
peritoneal
cavity’s
cavity’s inlet
inlet flow
flow to
to the
the bag
bag set’s
set’s outlet
outlet flow
flow connection.
connection.
Appl. Sci. 2021, 11, 1502 13 of 20
Table 8. Flow, pressure, and vorticity behavior of the fluid in the BP and PB connectors in the
drainage process.
Table 8. Flow, pressure, and vorticity behavior of the fluid in the BP and PB connectors in the
drainage process. Drain Fluid Process
Flow (mm/s) Pressure (MPa) Vorticity ( )
Drain Fluid Process
Outlet Inlet Peri- Outlet
Parameters Inlet Perito-
Flow (mm/s) Inlet Perito- Outlet
(s−1 )Drain-
Drainage tonealPressure (MPa)
Drainage Vorticity
nealInlet
Cavity Outlet Inlet neal Cavity age Bag
Parameters Bag Cavity BagOutlet Inlet Outlet
Peritoneal Drainage Peritoneal Drainage Peritoneal Drainage
BP con- Cavity 1.420
Bag Cavity Bag Cavity Bag
1.301 × 10 0.00078 0.00075 1.06 0.42
nector
BP × 10
1.301 × 10−4 1.420 × 10−3 0.00078 0.00075 1.06 0.42
connector
PB con- 1.429
1.709 × 10 0.00075 0.00067 1.06 0.40
PB
nector 1.709 × 10−4
× 10
1.429 × 10−5 0.00075 0.00067 1.06 0.40
connector
Three-dimensional printing
Three-dimensional printing andand fused-deposition
fused-deposition modeling
modeling obtained
obtained two
two detailed
detailed
prototypes to verify the assembly between the devices developed with
prototypes to verify the assembly between the devices developed with trademarks. The trademarks. The
3D models
3D models allowed
allowed usus to
to establish
establish manipulation
manipulation and and to
to estimate
estimate the
the exchange
exchange of
of fluid
fluid
leaks through the connectors. It is essential to point out that the prototypes obtained
leaks through the connectors. It is essential to point out that the prototypes obtained with with
this material and by this method made it possible to specifically evaluate and
this material and by this method made it possible to specifically evaluate and analyze the analyze the
necessary criteria for the existing problem and follow-up on the corresponding
necessary criteria for the existing problem and follow-up on the corresponding stage. stage.
3.6. Titanium
3.6. Titanium Manufactured
Manufactured Connectors
Connectors
The
The connectors
connectors were
were manufactured
manufactured with
with titanium
titanium “Ti-6Al-4V-ELI”,
“Ti-6Al-4V-ELI”,which
whichisisused
usedto
to
develop medical devices in the health sector. The connectors’ main function in
develop medical devices in the health sector. The connectors’ main function in this mate- this material
lies ® and ® commercial
rial in
liesaccurately connecting
in accurately thethe
connecting Baxter
Baxter PISA
® and PISA ® commercial devices.
devices.The
Thethreading
threading
of
of the
the connectors
connectors waswas manufactured
manufactured with
with support
support for for both
both internal
internal and
and external
external threads,
threads,
adapting
adapting them to toestablish
establisha amixture
mixtureofof equipment
equipment from
from bothboth brands.
brands. The connectors
The connectors were
were manufactured
manufactured based based
on on
thethe proposed
proposed detaileddesigns.
detailed designs. Engineering
Engineering drawings and and
sketches
sketches were developed for the manufacturing of BP and PB connectors
developed for the manufacturing of BP and PB connectors to generate them to generate
them in titanium
in titanium alloy, followed
alloy, followed by a four-step
by a four-step process process in approximately
in approximately six hourssix hours of
of manufac-
manufacturing.
turing.
i. 5/8 “TIAL6V4” Titanium aluminum alloy bar is trimmed to a certain length for
i. 5/8 “TIAL6V4” Titanium aluminum alloy bar is trimmed to a certain length for each
each connector in two pieces per connector (total four pieces in 1.5 h);
connector in two pieces per connector (total four pieces in 1.5 h);
ii. Cannula drill for internal threads on the pieces for the linking points with the
ii. Cannula drill for internal threads on the pieces for the linking points with the com-
commercial devices (1.5 h process);
mercial devices (1.5 h process);
iii. Cannula drill for external threads on the pieces to join it in a single one with a
iii. Cannula drill for external threads on the pieces to join it in a single one with a forged
forged thread technique (1.5 h process);
thread technique (1.5 h process);
iv. Forged impact to obtain full BP and PB connectors (1.5 h process). Figure 8 shows
iv. Forged impact to obtain full BP and PB connectors (1.5 h®process). Figure 8 shows the
the BP connector manufactured with Ti-6Al-4V: Baxter infusion and drain bags to
BP connector manufactured with Ti-6Al-4V: Baxter® infusion and drain bags to PISA®
PISA® transfer line connection. It is used for the linking between elements.
transfer line connection. It is used for the linking between elements.
Figure 8.
Figure 8. BP
BP connector
connector manufactured
manufactured in
in titanium
titanium with
withbranded
brandedequipment.
equipment.
Appl.
Appl.Sci. 2021,11,
Sci.2021, 11,1502
x FOR PEER REVIEW 14
15ofof20
21
Similarly,Figure
Similarly, Figure99presents
presentsthe thePB
PBconnector’s
connector’smanufacture
manufacturethat
thatlinks
linksthe
theinfusion
infusion
bags
bagsand PISA®® drainage
andPISA drainage to
to the Baxter®® transfer
the Baxter transfer line,
line, obtaining
obtaining aa mix
mix between
betweenequipment
equipment
from
fromboth
bothbrands.
brands.
Figure9.9.PB
Figure PBconnector
connectorlink
linkmanufactured
manufacturedin
intitanium
titaniumwith
withequipment
equipmentfrom
fromboth
bothbrands.
brands.
The manufactured
The manufactured connectors
connectors do
do not
not present
presentcomplications
complications to
tothe
thethread
threadassembly
assembly
with
withthe
thetwo
twobrands’
brands’equipment;
equipment;ititwas
wasalso
alsofound
foundthat
thattheir
theirhandling
handlingisisappropriate
appropriateand
and
can be used for the DPCA procedure following the corresponding process and operating
can be used for the DPCA procedure following the corresponding process and operating
instructions.
instructions.
3.7.
3.7. Experimental
Experimental Testbed
Testbed
The
The experimentalconnector
experimental connectorvalidation
validationwaswascarried
carriedout
outby
byinspecting
inspectingthe
theairtightness
airtightness
in
in the areas at the linking join with the branded equipment through tests ininwhich
the areas at the linking join with the branded equipment through tests whichperito-
peri-
toneal fluid is recirculated through the BP and PB connectors are joined with
neal fluid is recirculated through the BP and PB connectors are joined with the branded the branded
equipment.
equipment. The The experimental
experimentaltestbed
testbedsimulates
simulatesthetheCAPD
CAPDprocedure,
procedure,which
whichconsists
consists
of
of dialysate
dialysate flow
flow from
from thethe
setset of bags
of bags to the
to the transfer
transfer line.line.
TheThe following
following materials
materials werewere
con-
considered
sidered for for
thethe manufacture
manufacture andand evaluation
evaluation of the
of the connectors:
connectors:
• A 40 mm MoAS-type IPS aluminum profile bars;
•• Aperistaltic
A 40 mm MoAS-type
centrifugal IPS aluminum profile bars;
pump;
•• A peristaltic centrifugal pump;
A high-luminescence leak detection kit.
• A high-luminescence leak detection kit.
The aluminum MoAs IPS bars allowed malleability in joining the BP and PB connectors
in an The
idealaluminum
way to theMoAsbrandedIPS products
bars allowed malleability
to perform in joiningasthe
the treatment BPas
well and PB connect-
possible. The
ors in an ideal way to the branded products to perform the treatment as
experimental testbed was adequate to visualize the fluid exchange configuration between well as possible.
the
The experimental
manufactured testbedand
connectors wasequipment
adequate from
to visualize
the mosttheused
fluid exchange
brands in theconfiguration
Mexican health be-
tween The
sector. the manufactured
infusion bags were connectors
placed and equipment
in a higher fromforthe
position most
each used brands
connector used inin the
the
Mexican health
treatment of CAPD.sector. The infusion
A peristaltic pumpbags
was were
used toplaced
movein thea liquid
higherthrough
positionthe forconnectors
each con-
nector
from theused in the
infusion treatment
bags of CAPD.
to the drain A peristaltic
bags. Figure 10 shows pump was used
a diagram of thetofunctionality
move the liquid
and
through the connectors from the infusion bags to the drain bags.
connection points among devices (commercial brands and BP and PB connectors). Figure 10 shows a dia-
gram of the functionality and connection points among devices (commercial brands and
BP and PB connectors).
Appl. Appl.
Sci. 2021, 11, 11,
Sci. 2021, x FOR
1502 PEER REVIEW 15 of 20
Figure 10. Titanium connectors linked with equipment from different brands.
In the procedure for detecting leaks at the connection points, the fluoresce
In the procedure for detecting leaks at the connection points, the fluorescent compound
pound
was In was
mixed the mixed
procedure
with withforthe
the dialyzing dialyzing
detecting
fluid fluid
leaks
bags to find atbags
leaks the
at to findconnections
leaks
theconnection
linking at the
points, linking
the con
fluoresce
between
between
devices.
pound devices.
Figure
was mixed Figure
11 shows 11
theshows
the testbed
with the testbed
constructed
dialyzing constructed
withbags
fluid all theto
elementswith all
at the
the elements
integrated.
find leaks int
linking con
between devices. Figure 11 shows the testbed constructed with all the elements int
Figure
Figure 11.11. Leak
Leak experimental
experimental bench
bench for forPB
BP and BPconnectors.
and PB connectors.
Figure
The11. Leak experimental
connectors were placedbench for BP and
on 3D-printed PBinconnectors.
bases the experimental testbed to bet-
The connectors were placed on 3D-printed bases in the experimental testbed
ter visualize the linked elements and the flow. Table 9 shows the configuration in the
visualize
experimentalthe linked
The connectors
bench elements
were
and the and
placed
evaluation on
of the flow. Table
3D-printed
airtightness 9 connector.
shows
bases
in each in thethe configuration
experimental in th
testbed
imental bench
visualize and the
the linked evaluation
elements and of
theairtightness
flow. Tablein
9 each
showsconnector.
the configuration in th
imental bench and the evaluation of airtightness in each connector.
Appl. Sci. 2021, 11, 1502 16 of 20
Appl.
Appl. Sci.
Sci. 2021,
2021, 11,
11, xx FOR
FOR PEER
PEER REVIEW
REVIEW 17
17 of
of 21
21
Table 9. Configuration of the experimental bench between the developed connectors and the com-
Table 9. Configuration
Table Configuration of the
the experimental bench
bench between the
the developed connectors
connectors and the
the com-
mercial9.
Table Configuration of
9.devices. of the experimental
experimental bench between
between the developed
developed connectors and
and the com-
com-
mercial devices.
Table 9. Configuration of the experimental bench between the developed connectors and the com-
mercial
mercial devices.
devices.
mercial devices. Leak Experimental Essays for PB and BP Connectors
Leak Experimental
Leak Experimental Essays
Essays for
for PB
PB and
and BP
BP Connectors
Connectors
Leak Experimental
Description
Leak Essays for PB and BP Connectors
Experimental
Experimental Essays for PB and BP ConnectorsAnalysis
Description
Description Experimental
Experimental Analysis
Analysis
Description
Description Experimental
Experimental Analysis
Analysis
PB connector
PB connector placed
placed on
on the
the 3D
3D base
base connecting
connecting
PB
PBconnector
PB
connector
connector placed
placed
placed
onon
on
thethe
3D3D
the base
base
3D connecting
connecting
base
the
connecting
the
the PISA
PISA
® infusion bag to the Baxter
® infusion bag to the Baxter
® infusion
® transfer
® transfer
® transfer
PISA
the PISA bag bag
® infusion to thetoBaxter
the Baxter line.
® transfer
the PISA® infusion bag to the Baxter® transfer
line.
line.
line.
line.
The airtightness
The airtightness of of the
the threaded
threaded evaluation
evaluation con- con-
The
The airtightness
airtightness of
of the
the threaded
threaded evaluation
evaluation con-
con-
nections
nections was
was
The airtightness verified
verified during
of theduring
threadedthe
the peristaltic
peristaltic
evaluation
nections
nections was
was verified
verified during
during the
the peristaltic
pump’s
connections
pump’s startup;
was
startup; the process
process
verified
the the peristaltic
evaluation
duringevaluation in-
peristaltic
in-
pump’s
pump’s startup;
startup; the
the process
process evaluation
evaluation in-
55 in-
pump’s
volved startup;
constantly theflowing
process evaluation
the liquid involved
for 5 min.
volved
volved constantly
constantly flowing
flowing the
the liquid
liquid for
for min.
min.
Leakconstantly
volved detection flowing
constantly was the liquid
flowing
performedthefor 5a
liquid
in min. Leak
for
dark 5 min.
room
Leak
Leak detection
detection
detection was
was performed
was performed
in a dark in
performed aa dark
room
in with room
dark a UV
room
Leakaadetection
with
with UV light was
lamp performed
(inspection inzones
a darkshown
zones room
shown
with lightUV
lamplight lamp
(inspection (inspection
zones shown in red).
with aa UVUV light
light lamp
lamp in
in
(inspection
(inspection
red).
red).
zones
zones shown
shown
in
in red).
red).
BP connector
BP connector placed
placed on
on the
the 3D
3D base
base connecting
connecting
BP
BP connector placed on the 3D base connecting
theconnector
BP
theconnector
Baxter placedonon
Baxter® infusion
® infusion
placed thethe
bag
bag to 3D
3D
to the base
base
the PISAconnecting
® transfer
connecting
PISA the
® transfer
the
the Baxter
®
Baxter
® infusion
infusion bag
bag to the ®PISA ® transfer
Baxter ®
infusion bag to thetoPISA
line.
line. the PISA ® transfer
transfer line.
line.
line.
Same airtightness
Same airtightness tests
tests were
were carried
carried out
out for
for the
the
Same
Same airtightness
airtightness tests
tests were
were carried
carried out
out for the
forfluid
the
BP
BP connector,
connector,
Same picturing
picturing
airtightness tests thecarried
the
were passage
passage of
outof the
forthe
the fluid
BP
BP
BP connector,
connector, picturing
picturing the
the passage
passage of
of the
the fluid
fluid
over
over the
the connector
connector, picturing
connector illuminated
the passage
illuminated by
of
by UV
the
UV light
fluid over
light (in-
(in-
over
over the connector
the connector
the spection
connector illuminated
illuminated by
by UV light
illuminated by UV light
(inspection
UV light (in-
(in-
spection zones
zones shown
shown in
in red).
red).
spection
spection zones
zones shown
zones shown in
in red).
in red).
shown red).
4. Discussion
4. Discussion
4. Discussion
4. Discussion
4. The connectors
connectors present
Discussion
The present aa specific
specific geometry
geometry and and ornament
ornament that that is
is ideal
ideal for
for dealing
dealing
with The
CKD
The connectors
in
connectors present
treatment. The
present aa specific
connectors
specific geometry
need
geometryto and
be
and ornament
operated
ornamentfrom that
an
that is ideal
ergonomic
is ideal for
for dealing
point
dealingof
with
with The
CKD
CKD connectors
in
in present
treatment.
treatment. The
The aconnectors
specific geometry
connectors need
need to
toand
be
be ornament
operated
operated that isan
from
from anideal for dealing
ergonomic
ergonomic with
point
point of
of
view
with
CKD for
view for
CKD nurses
in
in treatment.
nurses and
and patient
treatment.
The The helpers.
connectors
connectors
patient helpers. During
need
Duringneed
to bethe
to connection
be
operated
the operated
connectionfrom process
from of
an
an ergonomic
process of the BP
ergonomic
the BP and
point
and PB con-
point
of view
PB of
con-
view
nectors
view for nurses
with
forwith the
nurses and
and patient
commercial
patient helpers.
systems,
helpers. During
itthe the connection
is essential
During essential to follow
follow
the connection process
the of
hygiene
process the
of the BP
rules
BP and PB con-
established
for nurses
nectors and
the patient helpers.
commercial During
systems, it is connection to process of the
the BP
hygiene and PBand
rules PB con-
connectors
established
nectors
by each
nectors with
with the
medical
the commercial
unit to carry
commercial systems,
out the
systems, it is essential
treatment
it is of
essential to
CAPD,
to follow
from
follow the
the hygiene
the cleaning
hygiene rules established
process
rules toeach
the
established
with
by themedical
each commercial
unit systems,
to carry it isthe
out essential to follow
treatment of the hygiene
CAPD, from rules
the established
cleaning processbyto the
by
by each
handling
each medical
of each
medical unit
unit to
element
to carry
for
carry out
the
out the
the treatment
exchange
treatmentof of CAPD,
fluids
of CAPD,with from
the
from the
human
the cleaning
body.
cleaning process
Medical
process to
to the
per-
the
medical unit
handling of to carry
each out the
element fortreatment
the of CAPD,
exchange of fromwith
fluids the cleaning
the humanprocess
body. to Medical
the handling
per-
handling
sonnel
handling of
have
of each
each element
developed
element for
for the
strategies
the exchange
to better
exchange of
use
of fluids
resources
fluids with
with the
when
the human
they
human arebody. Medical
insufficient,
body. Medical per-
using
per-
sonnel
sonnel have developed strategies to better use resources when they are insufficient, using
sonnel have
have developed
developed strategies
strategies to to better
better use
use resources
resources when
when theythey are
are insufficient,
insufficient, using
using
Appl. Sci. 2021, 11, 1502 17 of 20
of each element for the exchange of fluids with the human body. Medical personnel have
developed strategies to better use resources when they are insufficient, using sterilization
methods in elements that allow their use for patients who require treatment in an emergency.
Switching from one transfer line brand to another involves surgical intervention. BP and
PB connectors are designed to provide an alternative to this problem, allowing immediate
medical care for patients following the treatment protocol established.
It is essential to mention that both the shapes and geometry of each connector model
(BP and PB) are correct for handling during the treatment process; this is an important
issue in order to avoid critical complications of CKD such as infections. It is necessary to
provide additional instructions to medical personnel or users to establish either BP or PB
connectors with commercial systems to perform CAPD treatment.
The limitations that this research present are described in the following details:
• The results presented through the SolidWorks® student version computer program in
this research demonstrate that the behavior of the fluid inside the designed connectors
is constant, without presenting any abnormalities, even with the reduction in diameter
in one of them. This allows us to validate the results obtained with another computer
package that uses the finite element method (MEF), establishing a relationship between
the results.
• Based on clinical analyses and knowledge of how to perform CAPD treatment, the
conditions were established in the numerical simulation that the BP and PB connectors
were subjected to. These determine the reliability of the results, which is acceptable.
On the other hand, the visual study of the experimental testbed showed no fluid leak
through the linking points.
• It would be ideal to use cell cultures for a final evaluation of the BP and PB connectors
to support a determination of null bacteriological presence inside them, followed by
in vitro tests to examine the infusion and drainage process of the treatment. NOM-152-
SSA1-1996 provides all instructions for examining medical devices in PD, highlighting
the importance of the cell cultures in plastic or metal alloy materials. The Comisión
Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) guidelines authorize
the use of medical devices when they are developed in facilities with controlled
environments and with a required hygiene grade.
The flow behavior inside the developed connectors does not present complications
causing leaks of the fluid at the connection points. The behavior in medical-grade plastic or
metal alloys is similar, so the employment of any connectors in the considered materials will
carry out the process of treatment of DPCA satisfactorily, emphasizing that the handling is
acceptable for each one. It is worth mentioning that the BP and PB connectors’ flow profiles
at the assembly points with transfer lines trademarks have increased flow at higher speeds,
making a difference from the commercial flow systems.
There is little information about the use of a combination of connected devices to
exchange fluids in the literature. Due to the lack of specific information and numerical
simulation and experimental results, this is an alternative in the CAPD employing the BP
and PB connectors’ innovation.
This research has succeeded in realizing the intellectual protection of the connectors
presented in this scientific report. It is essential to mention that these patents are authorized
for use under the following codes: patent MX/2020/008489 and patent MX/f/2020/000314.
It should be noted that the procedure required during CAPD begins with the connection
of the Tenckhoff® catheter line to the dialysis bag. This multiprocessing will increase by
one-step, which refers to connectors designed to generate the interchangeability of brands.
The certification of these new devices can be carried out by using an appropriate
manufacturing company that has the ISO 9000 standard for acceptable manufacturing
practices. The NOM-241-SSA1-2018 Good Manufacturing Practices for Medical Devices
classifies those connectors as class II, as they are known in medical practice, and they may
have variations in the material with which they are made or in their concentration generally
introduced into the body in less than thirty days. If these two requirements are met, a
Appl. Sci. 2021, 11, 1502 18 of 20
certificate can be requested from the corresponding Mexican entity called COFEPRIS to
market it in Mexico’s public and private health sector.
5. Conclusions
Continuous ambulatory peritoneal dialysis treatment is of the utmost importance, as
it completely replaces the kidney function in the human body. It was possible to design
two connectors that exchange the dialysate liquid, satisfactorily carrying out the treatment
procedure with the two commercial brands used in Mexico. Baxter® and PISA® devices are
made of polyvinyl chloride (PVC) and polyetheretherketone (PEEK), while the developed
connectors were manufactured using a titanium alloy (medical-grade) and ABS, achieving
a satisfactory connection between the elements and establishing a successful connection
without leaks.
Currently, in Mexico, there is not a tool to enable the use of a combination of the
two brands to perform the treatment of CAPD. The BP and PB connectors work as an
element to mix the infusion and drainage bags of one brand with the transfer line of the
other brand in order to accomplish this treatment. The assembly system in the developed
connectors employs a particular thread, avoiding leaks of the fluid once the connection
between the commercial devices with the BP and PB connectors is made. Additionally,
a mechanical seal was added to ensure the connection was airtight in order to avoid
pathological complications. Numerical tests allowed visual studios to analyze the fluid’s
behavior as it flowed through each connector. The BP connector flow profile patterns
for the infusion process reached 3 mm/s at the inlet bag connection, with a controlled
behavior of 2.201 × 10−2 mm/s at the outlet transfer line flow of 1.605 × 10−3 mm/s, which
means a decrease in the velocity; in the draining process, maximum velocity profiles is
1.420 × 10−3 mm/s at outlet drainage bag connection. The PB connector flow profile
patterns in the infusion process are 6 mm/s at the outlet transfer line, which is the
highest velocity in both cases; meanwhile, at the inlet bag, the connection decreased to
1.650 × 10−6 mm/s
It is important to mention at the internal duct; the neck flow profiles reach 74 mm/s;
in the drain, the process flow reaches 1.709 × 10−4 mm/s at the inlet of the transfer line;
at the internal duct neck in this connector, the velocity reaches 42 mm/s, and continue to
1.429 × 10−5 mm/s to the outlet drainage bag connection. Favorable results were obtained,
which allowed developing technical plans for the manufacturing of the connectors.
The connectors were manufactured in titanium “Ti-6Al-4V-ELI”; the linking was
established through the thread between devices, suiting it successfully. Experimental
leak detection evaluations in each connector and results determine the fulfillment of the
objectives and the necessity under which they were developed. Thus, melted deposition
technology is useful for considerable cost reduction, allowing observational and connection
studies, which helped to design a detailed connector. The 3D models obtained in ABS
accomplishing the connection and exchange of the fluid between the brands satisfactorily.
Additionally, each model (ornament and geometries) was accurately modeled, which is
why it was considered a highly efficient method for developing the connectors.
The immediate implementation of the BP and PB connectors will benefit a significant
amount of Mexico’s health sector, which helps around 8000 patients in institutions, as the
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE) will
perform the treatment with the transfer line that they are using. The experimental bench
developed can be used to carry out tests with the drainage bags containing the liquid discarded
by the human body; these tests would contribute to the research carried out so far.
The exchange of fluids between the infusion and drainage bags of one brand with
another brand’s transfer line was successfully achieved, considering the medical sector’s
connection criteria. The flow connector patterns show a considerable change due to the
diameter geometry and reductions in each connector. However, these changes do not
represent any complication in carrying out the procedure for CAPD treatment. From
this proposal, it is possible to use the BP and PB connectors in specific tests involving
Appl. Sci. 2021, 11, 1502 19 of 20
intervention with animals to carry out the exchange of fluids, verifying the connectors’
functionality and validating their use in the treatment of CAPD using the standards of
the Mexican organization COFEPRIS. The common connection procedure for treatment
consists of correctly joining linking points between the transfer line (from the human body)
to bags of the same brand under strict hygiene conditions. The use of the BP and PB
connectors adds two steps that allow the use of the transfer line from one brand with bags
from the other brand. Thus, the procedure involves (1) the correct handling and careful
connection with the transfer line once the connection is successful; (2) the correct handling
and careful connection with the bags under the same hygiene conditions.
Finally, it was determined that the developed connectors work correctly and can be
manufactured in any suitable material for use in the health sector, strictly complying with
the instructions for carrying out the treatment.
6. Patents
Patent MX/2020/008489 and patent MX/f/2020/000314 results from work reported
in this manuscript.
Author Contributions: Conceptualization, C.R.T.-S. and M.A.G.-C.; methodology, C.R.T.-S.; software,

M.A.G.-C.; validation, L.A.A.-P. and J.C.P.-R.; formal analysis, J.C.P.-R.; investigation, C.D.l.C.-A.;
resources, C.R.T.-S.; data curation, J.C.P.-R.; writing—original draft preparation, M.A.G.-C.; writing—
review and editing, C.R.T.-S.; visualization, J.C.P.-R.; supervision, C.R.T.-S.; project administration,
C.D.l.C.-A.; funding acquisition, C.R.T.-S. All authors have read and agreed to the published version
of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: This study did not require ethical approval.
Informed Consent Statement: Not applicable.
Data Availability Statement: Not applicable.
Acknowledgments: The authors thank the Consejo Nacional de Ciencia y Tecnología (CONACyT)
and the Instituto Politécnico Nacional for the support received in the 20201964, 20200930 and
20210282 projects, as well as the support project “Proyectos de Desarrollo Tecnológico o Innovación
para alumnos del IPN 2019”, and finally the EDI grant, all from SIP/IPN. We appreciate the support
of the specialists in nephrology José Ocotitla-Hernández and Dra. María Guadalupe Suárez López
for the orientation in clinical subjects of CAPD who’s affiliations are Subdirección de Regulación y
Atención Hospitalaria, and Servicio de Diálisis Peritoneal, Hospital General Dario Fernández Fierro
at Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE).
Conflicts of Interest: The authors declare no conflict of interest.
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Publisher’s Note: MDPI stays neutral 1. Introduction

Appl. Sci. 2021, 11, 1502. https://doi.org/10.3390/app11041502 https://www.mdpi.com/journal/applsci

In Mexico, the most common renal replacement therapy in medical institutions is

Figure 1. Luxury connector diagram for development.

1.the An inlet flowThe

Appl. Sci. 2021, 11, 1502 5 of 20

The BP and PB connectors are designed to establish a successful connection between

Table 1. Dimensions of the SST 1200es printer.

Table 1. Dimensions of the SST 1200es printer.

Subsequently, the performance of the designs was evaluated by numerical analyses of

3.1. Fluid Computational Dynamics

3.1. Fluid Computational Dynamics

Figure 7. PB connector, join points, and thread features.

Appl. Sci. 2021, 11, 1502

3.4. PB Connector in the Infusion Process

Appl. Sci. 2021, 11, 1502 13 of 20

Author Contributions: Conceptualization, C.R.T.-S. and M.A.G.-C.; methodology, C.R.T.-S.; software,

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