Durability of Commercially Available Tipless
Stone Baskets
Rita Mucavele1
1
C. R. Bard, Inc., Covington, Georgia
Abstract
Background & Purpose: Today, tipless nitinol stone baskets are used to
aid in the capture of calyceal calculi during flexible ureteroscopy. We
investigated the durability of 2 commercially available tipless nitinol
stone baskets (1.9 Fr Bard® SkyLite™ Stone Basket and the 1.9 Fr Boston
Scientific ZeroTip™ Stone Basket) in a bench top model.
Materials and Methods: The baskets were evaluated for durability for
stone capture. One (1) capture of an 8mm simulated calculus was
performed in vitro per basket (size was determined by caliper). A total
of 25 baskets were used for each brand of basket (1.9 Fr Bard® SkyLite™
Stone Basket and 1.9 Fr Boston Scientific ZeroTip™ Stone Basket) for
a total of 25 stone captures per brand. Durability, defined as the length
between the end of the basket tip and end of the sheath (basket length),
was measured by caliper prior to stone capture and after stone capture,
for both the open and closed basket positions.
Results: The change in closed basket length of the 1.9 Fr Bard® SkyLite™
Stone Basket and 1.9 Fr Boston Scientific ZeroTip™ Stone Basket
averaged 0.1112mm (± 0.1617, p<0.001) and 1.0732mm (± 0.5883,
p<0.001), respectively. The change in open basket length of the 1.9 Fr
Bard® SkyLite™ Stone Basket and 1.9 Fr Boston Scientific ZeroTip™ Stone
Basket averaged 0.4984mm (± 0.4489, p<0.001) and 2.0332mm (±
0.9883, p<0.001), respectively.
Conclusion: As reflected by the average change in closed basket length
and open basket length, the data suggest that the Bard® SkyLite™ 1.9
Fr basket is more durable than the Boston Scientific ZeroTip™ 1.9Fr
basket after exposure to 8mm simulated calculus.
© 2016, C. R. Bard, Inc. All rights reserved
Introduction and Objective
The advent of smaller retrieval devices for the capture of
renal calculi in Endourology has allowed for greater access
to nearly all parts of the renal collecting system through
flexible ureteroscopy. However, as retrieval devices have
become smaller, the sacrifice of durability begins to come
into question. The aim of this study was to investigate
the durability of 2 commercially available tipless nitinol
stone baskets (the 1.9 Fr Bard® SkyLite™ and the 1.9Fr
ZeroTip™ by Boston Scientific, 300 Boston Scientific Way
Marlborough, MA 01752-1234) on a bench top model via
simulated stone capture.
Materials & Methods
A total of twenty five (25) new and unused 1.9 Fr Bard®
SkyLite™ Stone Baskets and twenty five (25) new and
unused 1.9 Fr Boston Scientific ZeroTip™ Stone Baskets
were evaluated. The baskets were evaluated for durability
by performing a single stone capture on an 8mm simulated
calculus (ball gauge). For both the closed basket position,
basket fully retracted into the sheath, and the open basket
position, basket fully protruding from the sheath (see
Figure 4), the length between the end of the basket tip
and the end of the sheath (basket length) were measured
by caliper prior to stone capture and after stone capture.
One key differentiation in the basket designs was the
addition of a spring-loaded sheath in the handle of the
Bard® SkyLite™ Stone Basket. The spring loaded sheath is
designed to protect the basket from damage or distortion
during stone retrieval. The Boston Scientific ZeroTip™
design does not incorporate a spring mechanism.
Results
Figure 3 displays the durability data results. The 1.9 Fr
Bard® SkyLite™ Basket exhibited the smallest change in
closed basket length. The 1.9 Fr Bard® SkyLite™ Stone
Basket averaged 0.1112mm (± 0.1617, p<0.001) and 1.9
Fr Boston Scientific ZeroTip™ Stone Basket averaged
1.0732mm (± 0.5883, p<0.001). The change in open
basket length of the 1.9 Fr Bard® SkyLite™ Stone Basket and
1.9 Fr Boston Scientific ZeroTip™ Stone Basket averaged
0.4984mm (± 0.4489, p<0.001) and 2.0332mm (± 0.9883,
p<0.001), respectively.
Discussion & Conclusion
As reflected by the average change in open and closed
basket length, the Boston Scientific ZeroTip™ basket
changed length by an average of 0.962mm more & 1.53mm
more, respectively, when compared to the Bard® SkyLite™
basket. The data suggest that the Bard® SkyLite™ basket
is more durable than the Boston Scientific ZeroTip™ 1.9F
basket after exposure to the 8mm simulated calculus. The
combination of the basket and the drive cable exposed
outside the sheath stayed closer to its original position in
the Bard® SkyLite™ 1.9 Fr basket, as evidenced by smaller
change in length after stone capture.
All baskets tested for durability comparison maintained
their shape after exposure to the 8mm simulated calculus.
The amount of drive cable that extends beyond the sheath
was the only variable between before and after closing the
8mm ball inside the basket.
After exposure to simulated calculi, the Boston Scientific
ZeroTip™ basket length elongates (distorts) up to 9X
more, on average, when compared to the Bard® SkyLite™
basket, in the closed position. In the open position, the
Boston Scientific ZeroTip™ basket length distorts up to 4X
more, on average, when compared to the Bard® SkyLite™
basket. The spring loaded sheath design within the Bard®
SkyLite™ basket protects the basket from damage, deemed
as elongation, during stone retrieval.
Figure 3: Basket Durability Comparison Data
Basket Durability Comparison
0.1112
Closed Position
Change in Length
1.9Fr BARD® SKYLITE™ Basket
1.0732
1.9Fr Boston Scientific
ZeroTip™ Basket
0.4984
Open Position
Change in Length
2.0332
0
0.5
1
Length (mm)
1.5
2
2.5
IMAGES OF BASKETS- Figure 1
A: Before Stone Capture
Bard® SkyLite™
Basket
B: After Stone Capture
Boston Scientific
ZeroTip™ Basket
Bard® SkyLite™
Basket
Boston Scientific
ZeroTip™ Basket
Figure 1: A.) The Boston Scientific ZeroTip™ and the Bard® SkyLite™ baskets in the closed position before capture of
a simulated 8mm calculus. B.) The Boston Scientific ZeroTip™ and the Bard® SkyLite™ baskets in the closed position
after capture of a simulated 8mm calculus. The change in length after stone capture is recorded as the change in
basket length for the closed position.
IMAGES OF BASKETS w/ RULER- Figure 2
A: Before Stone Capture
Boston Scientific
ZeroTip™ Basket
B: After Stone Capture
Bard® SkyLite™
Basket
Boston
Scientific
ZeroTip™
Basket
Bard® SkyLite™
Basket
Figure 2: A.) The Boston Scientific ZeroTip™ and the Bard® SkyLite™ baskets in the open position before capture of a
simulated 8mm calculus. B.) The Boston Scientific ZeroTip™ and the Bard® SkyLite™ baskets in the open position after
capture of a simulated 8mm calculus. The change in length after stone capture is recorded as the change in basket
length for the open position.
Figure 4: Basket Test Diagrams
Basket in the open
position, prior to
stone capture
Change in the basket length for
the open position
Basket in the open
position, after
stone capture
Basket in the closed
position, prior to
stone capture
Change in the basket length for
the closed position
Basket in the closed
position, after
stone capture
Indications for Use:
Precautions:
The Bard® SkyLite™ Tipless Nitinol Stone Basket is intended
for use in endoscopic removal of ureteral and renal stones.
Before using, inspect for any breach of packaging to
ensure sterility of product. Do not use if breach in sterile
barrier is obvious or suspected. Do not allow the device to
come in contact with any electrified instruments or laser.
Kinks in the sheath will hinder the mechanical operation
of the basket, may affect insertion or withdrawal of the
basket and has the potential to damage the endoscope’s
instrument channel. Do not allow the device to be directly
fired upon by any lithotripsy devices; doing so may result
in damage to the device and could result in patient injury.
Warnings:
•
•
Some objects may be too large to be removed
endoscopically using a retrieval device. The use of
fluoroscopy and/or x-ray to determine the size of
the object is recommended. Do not use the Bard®
SkyLite™ Tipless Nitinol Stone Basket if the object
is too large to be removed endoscopically, as it
may result in patient injury and pain.
Adverse Events
This is a single use device. Do not resterilize any
portion of this device. Reuse and/or repackaging
may create a risk of patient or user infection,
compromise the structural integrity and/or
essential material and design characteristics of
the device, which may lead to device failure, and/
or may lead to injury, illness or death of a patient.
Potential complications that may result from the use of a
basket in an endoscopic urological procedure include, but
are not limited to:
•
Do not attempt to repair, reassemble, or alter the
device in any way.
• Edema
•
After use, this product will be a potential
biohazard. Handle and dispose of in accordance
with accepted medical practices and with
applicable laws and regulations. Follow your
institutional guidelines.
Cautions:
Objects that are too large to be removed through
the scope channel will require the scope and basket
to be removed simultaneously from the urinary tract.
If resistance is encountered during advancement or
withdrawal of the device, stop and determine the source
of resistance, as continued resistance may damage the
device and could result in patient injury. Take action to
alleviate the resistance.
• Perforation
• Evulsion
• Entrapment
• Laceration
• Basket Inversion
• Hemorrhage
References
1. Skolarikos, Andreas, Andreas J. Gross, Alfred Krebs, Dogan Unal, Eduardo Bercowsky,
Ehab Eltahawy, Bhaskar Somani, and Jean De La Rosette. “Outcomes of Flexible
Ureterorenoscopy for Solitary Renal Stones in the CROES URS Global Study.” The
Journal of Urology 194.1 (2015): 137-43. Web.
2. Bach, T., M.D., B. Geavlete,, M.D., T.R.W. Herrmann,, M.D., and A.J. Gross,, M.D. “Working
Tools in Flexible Ureterorenoscopy-Influence on Flow and Deflection: What Does
Matter?” JOURNAL OF ENDOUROLOGY22.8 (2008): 1639-643.
Please consult product inserts and labels for any indications,
contraindications, hazards, warnings, cautions and directions for use.
C. R. Bard, Inc.
8195 Industrial Boulevard
Covington, GA 30014
1.800.526.4455
www.bardmedical.com
Bard and SkyLite are trademarks and/or registered trademarks of
C. R. Bard, Inc. All other trademarks are the property of their
respective owners. ©2016 C. R. Bard, Inc. All Rights Reserved.
1603-21 R04/16
BMD/STBK/0416/0006