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Atraumatic Circumcision Device(AccuCirc) Overview

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Entirely disposable kit with everything required to

perform newborn circumcision (anesthesia and sterile

gloves not included).

Atraumatic Circumcision Device Kit

Betadyne prep Circumcision drape

Surgical marking pen

2 curved hemostats

AccuCirc device

Gauze & wipe

Xeroform dressing

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Atraumatic Circumcision Device

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Atraumatic Circumcision Device Method of Use

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The included surgical pen is used to mark where the

incision will be made, helping to ensure the desired

amount of foreskin will be removed.

Create surgical pen mark

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The foreskin is gently pinched (pushing the glans

down and out of the way) and grasped at the 3:00 and

9:00 position.

Grasp foreskin

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The flexible probe of the shielding ring is used to

remove any adhesions that exist between the foreskin

and the glans.

Remove adhesions

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The shielding ring is inserted into the foreskin without

making a dorsal slit. If necessary, the foreskin can be

gently stretched to help accommodate the shield.

Insert shielding ring

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The foreskin holder is activated and the foreskin is

precisely positioned on the shielding ring.

Align foreskin

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Apply clamping and cutting device

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Activate lever arm until it locks,then release.

With a single actuation the device crushes and cuts the

foreskin.

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Atraumatic Circumcision Device outcome at 2 weeks

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Atraumatic Circumcision Device

Overview of Benefits

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A surgical pen is included in each kit. The pen mark helps

ensure the correct amount of skin is removed improving the

accuracy of the procedure. 1

Surgical Pen

1. Kaplan GW. Complications of circumcision. Urol Clin North Am 1983; 10543-549

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Some devices do not use a shield to protect the penis during

the clamping and cutting action. This can result in injury tothe penis regardless of the level of experience of the user.2

The Atraumatic Circumcision Device uses a shield that

protects the penis during the procedure.

Shield to protect penis

2. Strimling BS: Partial amputation of glans penis during circumcision. Pediatrics 97: 134-136, 1995.

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Some devices require a dorsal slit. This step can result in

injury to the urethra.3

The Atraumatic Circumcision Device isdesigned to be used without making a dorsal slit while still

using a shield that protects the penis. The need for scissors

and the dorsal slit is eliminated.

No Dorsal Slit

3. FDA MedWatch Reports, January 2000, "Potential for Injury from Circumcision Clamps"

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Some devices require the use of a safety pin to help position

the foreskin. The Atraumatic Circumcision Device uses a

foreskin holder that allows the provider to accurately position

the foreskin prior to the application of the clamping and

cutting device, ensuring a precise amount of skin is removed.

Foreskin Holder

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Mismatching device parts can lead to penile laceration.3 The

Atraumatic Circumcision Device has built in safety features

that protect against mismatching device parts. The device will

only work when the correctly sized shielding ring is locked in

place, ensuring the penis is protected during the procedure.

No mismatching parts

Unique Diametersact as a key to

ensure shield

matches clamp

3. FDA MedWatch Reports, January 2000, "Potential for Injury from Circumcision Clamps"

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The Atraumatic Circumcision Device eliminates the scalpel

and instead uses a circular self contained blade that is

precisely controlled by the device itself. By controlling the

circular blade, the device protects against injuring the penis.

Circular, Protected Blade

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The Atraumatic Circumcision Device delivers a hemostatic

crushing force (to control the bleeding). Following the

procedure, no string or bell is retained. This protects againsturinary obstruction and other complications related to retained

parts.4,5

No Retained Parts

4. Mihssin N. Retention of urine: an unusual complication of the Plastibell device. BJU International.

1999; 84, 745.

5. Jee LD. Ruptured bladder following circumcision using the Plastibell device. Br J Urol 1990;65:216-7

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Of particular importance in resource limited areas, the

Atraumatic Circumcision Device protects the contaminated

parts (blade and shield) and prevents their reuse.

Contaminated Instruments

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The Atraumatic Circumcision Device kit is entirely

disposable. No part requires reprocessing or re-sterilization.

This helps prevent injuries that can occur from worn or

mismatched clamps and, in resource limited areas,

contaminated instruments.

Entirely Disposable

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With any crushing and cutting device, the cutting surface will

have to be discarded. The Atraumatic Circumcision Device

protects the cutting surface and also functions as a disposable

clamping device with minimal waste.

Minimal Waste

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A single kit contains everything needed to perform newborn

male circumcision simplifying inventory and decreasing the

likelihood of a provider performing the procedure without

having the adequate supplies.

Self Contained Kit, Simplified Inventory

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Because the entire kit is disposable and requires no

reprocessing, no infrastructure is required to use this device.

The device is made out of inexpensive injected molded plastic

parts that can be manufactured in large volumes at a low cost.

Minimal Cost

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SummaryComplication AccuCirc Gomco Mogen Plastibell

Removal of excessive or

an insufficient amount

of foreskin.

Reduced risk

(prevented by using

a surgical marking

pen and foreskin

holder)

Increased risk

(difficult to gauge

amount of tissue

to remove)

Increased risk

(difficult to gauge

amount of tissue

to remove)

Increased risk

(difficult to gauge

amount of tissue to

remove)

Urethral Injury No risk(dorsal slit is

never made)

Increased risk

(dorsal slit

routinely required)

Reduced risk

(not all providers

use a dorsal slit)

Increased risk

(dorsal slit

routinely required)

Penile Laceration/

AmputationNo risk

(device ensures

protection)

Increased risk

(related to mis-

matched parts)

Increased risk

(glans is not

shielded)

No risk

Urinary retention,

bladder rupture, injury

from retained parts

No risk

(no retained parts)No risk

(no retained parts)No risk

(no retained parts)Increased risk

(bell stays in

place on infant)

Resource Limited Areas

Transmission of

Infection through

contaminated parts

Reduced risk

(Disposable,

contaminated parts

protected)

Increased risk

(Parts needs to be

processed and

sterilized)

Increased risk

(Parts need to be

processed and

sterilized)

Increased risk

(Scissors need to be

processed and

sterilized)

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Our goal has been to design and

engineer a device that can help protect

patients from accidental injury duringcircumcision, particularly in resource

limited areas and for the purpose of

HIV prevention.

Summary