Designed to
facilitate the delivery of silicone gel implants during
augmentation mammaplasty, The Keller Funnel™ is used
by trained surgeons throughout the United States. Inventor and
plastic surgeon Kevin Keller, M.D. developed the cone-shaped,
nylon device with a special interior coating that allows doctors
to easily propel an implant into place with minimal force.
Experienced users of the Keller Funnel™, as detailed
in our research
section, realized multiple benefits for both patients
and surgeons.
In December 2006, South Carolina-based plastic surgeon Kevin Keller, M.D. developed the first prototype of the Keller Funnel™ as a result of the reintroduction of silicone gel implants to the U.S. market. Keller wanted to place the pre-filled silicone gels with the same, smaller incision lengths used for saline implant procedures.
Keller partnered with biomedical engineer Howard Preissman, to create a hydrophilically coated delivery tool that facilitated the placement of gels during breast augmentation procedures. The product was launched in August 2009. To date, hundreds of plastic surgeons have adopted the use of the Keller Funnel™ during silicone gel breast augmentation
procedures. For more information, please call (310) 392-9842.
What is
the Keller Funnel™?
The Keller Funnel™
is a device intended to assist with the delivery of pre-filled
implants by providing a low friction shell-tissue interface during
implant insertion using a no-touch technique to prevent
contamination. Cone shaped and made of nylon, the hydrophilic
coating inside the funnel becomes extremely lubricious when
submerged in a saline or sterile solution.
How and
why is the Keller Funnel™ used?
Once the implant is
placed inside the funnel, the surgeon places the small distal end
into the prepared breast pocket and using a pushing/squeezing
motion easily propels the implant into place. Surgeons experienced
in using the Keller Funnel™ report that the device:
employs a no-touch delivery technique; decreases surgery time and
physician fatigue; limits local stress on implant shell which may
lead to rupture; reduces incision lengths; and lessens trauma to
patient tissue.
Where
can I find hospital ordering information, FDA registration, etc.?
Keller Medical,
Inc. has compiled information to help facilitate discussions that
hospital product board review committees may conduct. You can find
it here.
Where
can I find the Instructions for Use for the Keller Funnel™?
Keller
Inc. has created Instruction
for Use to ensure information on proper usage is available. It
is available
as a PDF.
Are
there any biocompatibility issues with the hydrophilic coating and
the surface of the gel implant?
No, the company
uses LubriLAST™, a proprietary hydrophilic coating
manufactured and applied by AST technologies of Billerica, MA.
LubriLAST™ passes all stringent biocompatibility tests
associated with tissue and blood contacting devices. For more
information please visit the following link: http://www.astp.com/coating/lubrilast.html
How do
hydrophilic coatings work?
The supporting
polymer network is cross-linked and covalently bound to the
substrate. This network normally does not swell in water. In
LubriLAST™, a long chain, biocompatible hydrophilic
polymer is incorporated into the coating. Part of this long
hydrophilic polymer becomes entangled with the supporting network
while other part remains exposed and able to become hydrated. When
in the presence of water or body fluids, the hydrophilic polymer
LubriLAST™ absorbs water molecules to create a watery
interface at the surface of the device. The water cushion reduces
wet friction, protein adsorption and cell adhesion.
Explain
how the product uses a no-touch technique.
Open the sterile,
double-pouched packaging of the Keller Funnel™ and
submerge the device in saline or antibacterial solution. We
recommend surgeons keep breast implants in their original
packaging, submerged in saline or an antibacterial solution. While
the surgeon holds open the wide end of the Keller Funnel™,
the nurse can pour the implant from its original packaging
directly into the funnel. Once tested and loaded properly, the
surgeon places the funnel tip into the breast pocket and propels
the implant into place using a no-touch technique.
Can the
device be used with all varieties of gel implants?
Yes, both smooth
and textured and implants up to 800cc have been used successfully
with the Keller Funnel™. Note: textured implants
require using slightly more force than smooth gel implants.
Can the
Keller Funnel™ be used in transaxial, periareolar and
mammary fold procedures?
Yes, the Keller
Funnel™ can be used in all three procedures. Keller
Medical, Inc., however, recommends that first time users of the
device try inserting with an inframammary fold or periareolar
approach.
When
using the device, what size should my incision length be?
Surgeons with
experience using the Keller Funnel™ report that the
device allows for much smaller incisions as compared to the
traditional insertion method. With practice, most silicone
implants may be inserted through the same size incisions used for
saline implants, but surgeons should practice best methods for
inserting implants as dictated by the implant manufacturers.
Can I
speak with a surgeon who has used the device?
Please contact us
by
or by calling a representative who can assist you with your
request at (310) 392-9843.
How
many times can a Keller Funnel™ be used?
The Keller Funnel™
is intended for single use only. A single use includes a testing
before insertion and both breast implantations of the same
patient. It is not to be re-sterilized by any means and no testing
has been performed to assure re-sterilization would be effective.
How
can I get more information about the Keller Funnel™?
Contact MedEdge, Inc. at
(310) 392-9843 or
us with any questions or
comments.
Please allow 24
hours to receive an email status update regarding your
certification test results.
Once received and your account activated you may order
online,
by phone at (310) 392-9843 or by fax at (310) 581-1972.
If you require
immediate verification of your test results please contact customer
service directly.
Take
The Certification Test
information to third parties, except as required by
law.
Confidentiality policy provided upon request.
Certification Test
Doctor Name
Phone Number
Email Address
Mailing Address
Question 1: Check all that apply
The Keller Funnel™ must be tested prior to implantation
to:
Activate
hydrophilic coating
Determine
if funnel mouth is cut to the appropriate size
Gain proper
feel for smooth/textured implant propulsion
Question 2: True or False
When inserting the Funnel into the breast cavity
remember to place the tip about 1 cm into incision site
to prevent folding of funnel mouth
True
False
Question 3: True or False
To achieve a true no-touch technique, the implant may be poured
directly from its sterile container into the Keller Funnel™.
True
False
Question 4: True or False
Testing the travel of the implant through the funnel to
assure it is sized properly may result in a tear. This safety feature helps protect implants from rupture.
True
False
Question 5: True or False
One Keller Funnel™ can be used for both breasts and may
be re-sterilized or re-used for additional patients.
True
False
Question 6: True or False
As a rule, textured and shaped implants require a distal
opening smaller the equivalent-sized smooth, round
implants.
True
False
Question 7: Check all that apply
First time users of the Keller Funnel™ should:
Use a
textured implant
Use a
smooth silicone gel implant
Use a 3 to
3.5 centimeter incision site
Question 8: Check all that apply
The Keller Funnel™ is designed to:
Decrease
surgery time
Minimize
physician fatigue
Limit
local stress on implant shell
Reduce
incision lengths
Deliver
silicone gel breast implants with a no-touch technique
The
Keller Funnel™: Does it Hold Up to its Claims? — By
James C. Grotting, MD & William J. Vinyard, MD
OBJECTIVE: To test this device and report our clinical experience
to determine if the claims are valid.
New
Technology: Keller Funnel™ Improves Practice
Efficiency — By Scot A. Martin, MD I
have used the funnel on 120 patients now and I feel that all the
concerns I had with placing a silicone gel implant in the past are
gone. I use the Keller Funnel™ on every gel case. My
incisions are smaller (about one centimeter shorter on average),
operative times are less (approximately 6 minutes on average) and
fears of skin flora contamination are completely gone as this is
essentially a no touch technique.
Keller
Funnel™ Addresses Capsular Contracture and Implant
Rupture Complications Clinical
papers suggest that while the causes of capsular contracture are
multi-factorial, exposure to biofilms and bacterial contamination
almost certainly have a relationship. Limiting handling of the
implants and limiting skin contact prior to the insertion are also
suggested.
Keller
Funnel™ Reduces Insertion Force By Over 95% As
the bar graph below illustrates, the traditional finger push
method requires over 27 pounds of force to deliver a 400 cc
silicone implant through a 3.5 cm incision. The Keller Funnel
reduces that force by over 95% to only 0.64 pounds.
ABSTRACT:
2 Year Clinical Experience Using a Novel Device for Gel
Implantation Kevin
Keller, M.D., Elizabeth Rothman Blakemore, M.D., James E. Lovett
III, M.D.
Upstate Plastic Surgery, Greenville, SC, April 2009
With the re-introduction of cohesive gel implants in 2006, we were
challenged to find a means to continue to offer axillary or
periareolar incisions for our primary augmentation patients
without enlarging the incision for the gel devices. With this goal
in mind, an insertion device called the Keller Funnel™
was developed.
Dr. John Paul
Trevisani wrote
“If you want a smaller scar, then ask for the Funnel!”
Dr. Richard A.
Moss blogged
“‘The Keller Funnel’ may be the best improvement in
breast augmentation since the FDA approval of silicone gel
implants in 2006.”
American
Health and Beauty blogged
“Dr. Johan Brahme of La Jolla, CA uses the Keller Funnel
and describes, ‘The Keller Funnel is lined with a slick
coating which allows the implant to be easily squeezed
through the opening.'"
The
Austin-Weston Center for Cosmetic Surgery posted
“The Keller FunnelTM is a cone-shaped, nylon
device that allows for your surgeon to use a no-touch
delivery technique during breast augmentation, which is
believed to reduce infection complications.”
American
Health and Beauty posted
“Keller Funnel Makes Placing Breast Implants Easier for
the Physician, Safer for the Patient”
The
JustGotEm.com Blog wrote
“Now physicians have a new tool to help them more easily
place the silicone implant, the Keller Funnel No Touch
Technique. The funnel is similar to a baker's bag, like the
ones used for icing and decorating cakes, and it allows the
doctor to insert the breast implant without having to touch
the implant, greatly reducing the risk of
infection.”
Andrew
Kaczysnski, MD of Sacramento, CA blogged
“I am very pleased to now be using the new Keller Funnel
that allows us to improve the quality of breast
augmentation.”
Michael
Ciaravino, MD of Houston, TX blogged
“The Keller Funnel makes implant placement easier by
allowing for a smaller incision, less trauma to the implant
shell as well as the breast tissue.”
Brian
Dickinson, MD of Beverly Hills, CA blogged:
“I have found that the Keller Funnel facilitates delivery
of silicone gel implants through smaller incisions.”
Joseph A
Racanelli, MD blogged:
“This device has enabled me to decrease my standard
incision for silicone implants by at least 1.5 cm, and
decrease surgery time.”
Lee Corbett,
MD of Louisville, KY blogged
“The Keller Funnel allows the implant to be placed without
being touched or touching the skin which minimizes infection
and capsular contracture.”
David
Broadway, MD of Denver, CO blogged:
“Dr. Broadway is the first plastic surgeon in Colorado to
offer his patients the Keller Breast Funnel. This unique
device was designed by a plastic surgeon to aid in breast
augmentation procedures.”
Dr. Adler, Dr.
Coccarro and Dr. Kneessy of East Setauket, NY blogged
that they are “pleased to announce that they are now
using the NEW ‘Keller Funnel’ for Breast implant
delivery.”
Thomas Fiala,
MD of Orlando, FL blogged
that the Keller FunnelTM “...does work for its
primary purpose — the implant slides into the surgical
pocket, easy as can be.”
Keller
Medical Hospital Bulletin
To facilitate discussions with hospital product review committees,
we have created the Keller Medical Hospital
Bulletin PDF file.
Volume
Purchase Agreements
We do offer annual purchase agreements for those customers
committed to buying in bulk, but concerned with shelf life
expiration dates. Pricing is based on the number of cases to be
purchased over the course of twelve months and must be accompanied
by an executed contract with an approved method of payment. To
view our purchase agreement, please call our customer service
department.
Shipping
All orders are routinely shipped UPS ground with a per shipment
charge of $15.00. Other shipping arrangements for more immediate
delivery can be made and will be billed at cost. Florida customers
must pay 6.5% sales tax.
Product
Warranty
Keller Medical stands behind the Keller Funnel™. If
for any reason you experience difficulty resulting in the use of
more than one funnel per patient, we will replace it. If after
using your first full box of Keller Funnels, you are not
completely satisfied with your purchase, please call our Customer
Service Department to receive a full refund.
