Instructions for Use

NEXUS Hemorrhoid Ligator Instructions for Use

INDICATIONS FOR USE:

The inx Medical Nexus® Hemorrhoid Ligator includes suction and ligation capabilities. The ligator is used to disrupt blood flow to hemorrhoidal tissue by means of a ligature placed around the hemorrhoid base. It is for use only by trained medical personnel in hospitals, clinics, and doctors’ offices.

NOTES:

• Do not use this device for any other purpose other than the intended use.
• The Nexus Hemorrhoid Ligator is intended to be used only by medical personnel trained in proctology procedures.
• Store in a clean, dry location, at room temperature.

CAUTION:

US Federal law restricts this device to sale by or on the order of a physician.

CONTRAINDICATIONS:

Do not use to treat:

• Anal polyps
• Grade IV hemorrhoids and external hemorrhoids
• Patients with perineal infection
• Patients with perineal Crohn’s Disease
• Patients with portal hypertension
• Patients who are pregnant
• Use with caution when treating patients on anticoagulants or with bleeding disorders

PRECAUTIONS:

The Nexus Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with 4 preloaded not made with natural rubber latex rubber bands. Typically a maximum of 3 bands are used during one procedure. An additional band is included as spare.

INSTRUCTIONS FOR USE / PROCEDURE:

1. Remove the Nexus Hemorrhoid Ligator from its packaging.
2. Perform a digital rectal exam (DRE), then an anoscopy.
3. Introduce the anoscope into the rectum, targeting the neck of the hemorrhoid to be banded.
4. Introduce the Nexus Hemorrhoid Ligator through the anoscope, and place the tip of the ligator on the hemorrhoid to be banded.
5. Squeeze and hold the suction trigger.
6. Ask the patient if they are experiencing rectal pain. If they are having pain, release the suction trigger; advance the ligator 2-3 mm further into the rectum and repeat steps 4 and 5.
7. Hold suction by continuing to squeeze the suction trigger.
8. While squeezing the suction trigger, pull and release the band trigger to apply a band.
9. Release the suction trigger.
10. When both triggers are released, the Nexus Hemorrhoid Ligator will automatically reload the next band.
11. Remove the Nexus Hemorrhoid Ligator and the anoscope from the patient.
12. Repeat a DRE and determine if the following criteria have been met:
    1. A sufficient amount of tissue has been banded. The banded tissue should feel like the size of a pea.
    2. The banded tissue moves freely when gently probed.
    3. The neck of the banded tissue should be small and not broad based.
    4. There is no pain on palpation of the banded tissue.
13. If the above four criteria are not met, then digitally manipulate the band to attempt to either slightly decrease the amount of tissue that has been banded or remove the band completely.
14. As per the discretion of the physician, one or two additional bands may be applied to other areas of the rectum by repeating steps 3 through 13.
15. After the procedure is completed, dispose of the Nexus Hemorrhoid Ligator in an approved manner.

POSITIONING OF THE BAND:

The band is applied to the proximal end of the hemorrhoid. The resulting ulceration stimulates a fibrous reaction which gradually adheres the mucosa to the deeper tissues of the rectum and decreases blood flow to the hemorrhoid vessels. Hence, the banding process treats the hemorrhoids by both diminishing blood flow and fixing the mucosa to deeper structures which decreases prolapse. The band must be applied to the most proximal portion of the hemorrhoid since this area is typically not innervated with pain receptors.

1. Question: How does it work? Rubber band ligation works by inducing necrosis and a fibrous reaction at the neck of the hemorrhoid resulting in occlusion of the hemorrhoid vessels. The fibrosis results in attachment of the rectal mucosa to deeper tissues which reduces prolapse.
2. Question: Is it necessary for the whole hemorrhoid tissue to be banded? No, only 1-2 mm of tissue needs to be ligated. The size of the tissue ligated is not important so long as there is enough tissue captured to prevent the band from falling off immediately after it has been applied.
3. Question: How many bands are needed for each hemorrhoid? One band is sufficient for each hemorrhoid. If more than one hemorrhoid requires treatment, additional bands can be applied at one setting or the patient can return for repeat single hemorrhoid banding at 2-3 week intervals.
4. Question: Is the design of the ligator important? The design of the ligator will influence its effectiveness. When used in conjunction with an anoscope, the long slender suction barrel allows for optimal visualization of the hemorrhoid tissue which improves band placement accuracy. Also, the diameter of the barrel tip and the overall configuration of the suction chamber increases the likelihood of only the rectal mucosa being ligated and not the deeper muscle layers. Ligation of the muscle can result in significant pain.

DEVICE DESCRIPTION:

The inx Medical Nexus Hemorrhoid Ligator is a non-invasive, simple and easy to use disposable device to be used by a physician to apply not made with natural rubber latex bands for the treatment of hemorrhoids. The ligation bands diminish the blood supply to the hemorrhoid resulting in a reduction in the size of the hemorrhoid. The ligation also causes inflammation and fibrosis which causes the rectal mucosa to adhere to deeper tissues which reduces prolapse. It is a hand held device that does not require additional equipment or personnel to operate, and it utilizes an internal plunger mechanism to suck the hemorrhoid tissue into the barrel of the device. The suction mechanism is activated by squeezing a trigger. Once the hemorrhoid tissue is suctioned into the tip of the ligator, a firing trigger is pulled and a band is deployed. The device is pre-loaded with 4 not made with natural rubber latex bands, which will deploy one at a time, allowing the physician to easily treat multiple hemorrhoids during a single procedure.

PROCEDURE:

Perform a digital rectal exam (DRE) and an anoscopy. Introduce the Nexus Hemorrhoid Ligator through the anoscope into the anus aimed toward the hemorrhoid to be banded. The tip of the ligator should be lightly pressed against the proximal end of the hemorrhoid. The suction trigger is gently squeezed which draws the hemorrhoidal tissue into the tip of the ligator. With the suction trigger compressed, pull and release the band firing trigger to deploy a band onto the hemorrhoid. Release the suction trigger and the ligator is immediately ready to apply additional bands.