Atraumatic Circumcision Device (AccuCirc) Overview

Atraumatic Circumcision Device Kit Betadyne prep Circumcision drape Surgical marking pen 2 curved hemostats AccuCirc device Gauze & wipe Xeroform dressing Entirely disposable kit with everything required to perform newborn circumcision (anesthesia and sterile gloves not included).

Atraumatic Circumcision Device

Atraumatic Circumcision Device Method of Use

Create surgical pen mark 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.

Grasp foreskin The foreskin is gently pinched (pushing the glans down and out of the way) and grasped at the 3:00 and 9:00 position.

Remove adhesions The flexible probe of the shielding ring is used to remove any adhesions that exist between the foreskin and the glans.

Insert shielding ring 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.

Align foreskin The foreskin holder is activated and the foreskin is precisely positioned on the shielding ring.

Apply clamping and cutting device This is a series of pictures showing the application of the clamp

Activate lever arm until it locks, then release. This is a picture of the clamp in place and the results immediately post op. With a single actuation the device crushes and cuts the foreskin.

Atraumatic Circumcision Device outcome at 2 weeks

Atraumatic Circumcision Device Overview of Benefits

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

Shield to protect penis Some devices do not use a shield to protect the penis during the clamping and cutting action. This can result in injury to the 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. 2. Strimling BS: Partial amputation of glans penis during circumcision. Pediatrics 97: 134-136, 1995.

No Dorsal Slit Some devices require a dorsal slit. This step can result in injury to the urethra.3 The Atraumatic Circumcision Device is designed 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. 3. FDA MedWatch Reports, January 2000, "Potential for Injury from Circumcision Clamps"

Foreskin Holder 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.

No mismatching parts Unique Diameters act as a key to ensure shield matches clamp No mismatching parts 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. 3. FDA MedWatch Reports, January 2000, "Potential for Injury from Circumcision Clamps"

Circular, Protected Blade 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.

No Retained Parts The Atraumatic Circumcision Device delivers a hemostatic crushing force (to control the bleeding). Following the procedure, no string or bell is retained. This protects against urinary obstruction and other complications related to retained parts.4,5 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

Contaminated Instruments Of particular importance in resource limited areas, the Atraumatic Circumcision Device protects the contaminated parts (blade and shield) and prevents their reuse.

Entirely Disposable 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.

Minimal Waste 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.

Self Contained Kit, Simplified Inventory 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.

Minimal Cost 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.

Summary Complication 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) (difficult to gauge amount of tissue to remove) Urethral Injury No risk (dorsal slit is never made) (dorsal slit routinely required) (not all providers use a dorsal slit) (dorsal slit routinely required) Penile Laceration/ Amputation (device ensures protection) (related to mis-matched parts) (glans is not shielded) Urinary retention, bladder rupture, injury from retained parts (no retained parts) (bell stays in place on infant) Resource Limited Areas Transmission of Infection through contaminated parts (Disposable, contaminated parts protected) (Parts needs to be processed and sterilized) (Parts need to be processed and sterilized) (Scissors need to be processed and sterilized)

Summary Our goal has been to design and engineer a device that can help protect patients from accidental injury during circumcision, particularly in resource limited areas and for the purpose of HIV prevention.