How Cryoablation Works 


Safe. Effective. A proven technique.

Cryoablation is a time-tested therapy with proven success in treating many medical conditions. Gynecologists have used the technology for several years to treat other gynecological conditions.

Cryoablation uses sub-zero temperatures to reduce or eliminate the endometrium (See animation video). The natural analgesic affect of these low temperatures helps minimize patient discomfort during the procedure. Ultrasound guidance enables real-time visualization during the therapy for added safety.

 

Candidates for uterine cryoablation therapy

Her Option is intended for treatment of pre-menopausal women who have completed childbearing, and whose AUB symptoms are the result of benign causes.

 

Approximate duration of cryoablation procedure


Pre-procedure: 45 minutes
Procedure: 10-20 minutes
Post-procedure: 15 minutes
Total: 75-85 minutes

 

Preparing your patient for the cryoablation procedure

Give your patient a pre-procedure instruction sheet to prepare her for a smooth procedure. The sheet should also include specific patient recommendations and office contact information.

Consider the following recommendations:

Your patient may have a light meal 30-45 minutes prior to her treatment.
Have the patient arrive at your office approximately 30 minutes to one hour prior to the procedure time.
Your patient should have a comfortably full bladder for the treatment. Encourage her to drink two 8-oz. cups of water before she arrives.
Perform a urine pregnancy test 3-4 weeks prior to Her Option treatment. Obtain your patient’s consent for treatment at this time rather than on the day of the procedure. Doing so will prevent any confusion about whether consent was signed under the influence of preoperative medications.
If your patient has asked for a sedative, make sure she arranges transportation to and from the clinic.

 

Create a comfortable environment

Use these tips to help your patient relax for the cryoablation treatment:

Provide a procedure room that’s quiet, relaxing and comfortable.
Offer a blanket and pillows.
Turn down the lights.
Provide soft music in the room or on headphones.
Suggest that your patient move her legs around while the paracervical block takes effect.
Encourage staff to be friendly, empathetic, attentive and respectful.

 

Pre-treatment medical recommendations

A thinned uterine lining is recommended prior to cryoablation treatment. The following options may be used:

Natural option

Timed to the early proliferative phase, right after period ends

Medical options

Provera
Lupron
Danacrine
Birth control pills

 

Minimal anesthesia regimen

Pre-op

NSAIDs
Valium or Ativan (one hour prior)
Consider IM Toradol

Procedure

Paracervical block (optional)
Use 10 cc of lidocaine or bupivicaine

Post-op

NSAIDs or Percocet®

 

Step-by-step procedure


Procedure steps

Position patient

  1. Position the patient on the exam table and place in stirrups or footrests.
  2. Reconfirm uterine position by pelvic exam.
  3. Perform abdominal ultrasound to confirm bladder fullness and visibility of the uterus.
  4. If necessary, add fluid to the bladder for better uterine visualization.
  5. Gently prep perineum and vagina.
  6. Place sterile vaginal lubricant onto the tips of a large open-sided speculum and place into the vagina.
  7. Open speculum fully and secure in place.

Local anesthesia (May not be required with a parous cervix)

  1. Apply a topical anesthetic. Either 10-20cc of lidocaine or a topical spray such as Cetacaine® may be applied to the cervix and cervical canal.
  2. Insert a single tooth tenaculum to the anterior cervical lip.
  3. Apply gentle traction to the cervix and displace to one side of the vagina to enable paracervical injection to the first side.
  4. Paracervical block: Use up to 10 cc of ¼% bupivacaine on each side at the 4 and 8 o’clock positions.
  5. Allow five minutes for analgesia to take effect. If necessary, dilate the cervix to 6mm.

view of uterus in longitudinal view prior to insertion of cryoprobePrepare cryoprobe

  1. Depress the power On/Off button on the front of the console (power-up will take approximately 3 minutes).
  2. LCD display will show the "Her Option®" logo and two choices. Select "Start" to begin the procedure.
  3. The display panel directs the user to "Please Attach New Disposable." Remove the disposable cryoprobe from the tray.
  4. Connect the cryoprobe sheath over the cryoprobe and lock it into place.
  5. Pull the sterile plastic sheath over the handle and black flex line.
  6. Initiate PreCool when prompted by the console LCD panel.
Caution: It is very important that the PreCool cycle be conducted using the disposable cryoprobe that will be used for the treatment. Test cryoprobes should NOT be used for PreCool cycle.

view of probe post insertion in transverse viewUltrasound

  1. Grasp the tenaculum and apply gentle traction to straighten out the uterus.
  2. Carefully insert the cryoprobe slowly into the uterus and observe its path on the ultrasound.
  3. Advancing the cryoprobe, gently touch the right cornual area of the uterine cavity and confirm sonographically that the probe is inside the uterine cavity in a longitudinal view.
  4. You can confirm the probe is on the right sonographically in the transverse view.
  5. Inject approximately 5 cc of sterile saline through the bottom injection port, if desired, to improve ultrasound visualization.

view of cryozone development with first freezeBeginning freeze cycle

  1. Depress the negative [-] (freeze button) on the disposable cryoprobe to start the freeze cycle. A green light will appear on the cryoprobe indicating that freezing is occurring.
  2. Maintain the cryoprobe and tenaculum pressure until the cryoprobe tip temperature reaches minus 60°C.
  3. Relax tension on the cryoprobe and tenaculum and observe the gradual expansion of the cryozone on the ultrasound using both longitudinal and transverse views. The very dark or black area corresponds to the formation of the ice along and extending out from the cryoprobe.
  4. Continue the first treatment session for 4 minutes or until the cryozone gets within 5 mm of the serosa of the uterus.
  5. Depress the positive [+] (heat button) on the disposable cryoprobe.
  6. The LCD display on the console will read "Wait to Move Probe." This message will disappear when the cryoprobe tip temperature reaches positive 20°C.
  7. Once the "Wait to Move Probe" message disappears, gently rotate the cryoprobe back and forth and slowly withdraw the cryoprobe from the first cryozone.
  8. It’s not necessary to remove the cryoprobe from the uterus, but it must be withdrawn out to or near the internal cervical os.
  9. Reposition the cryoprobe handle to the opposite side of the uterus.
  10. Apply gentle traction on the tenaculum and gently slide the cryoprobe along side of the cryozone into the untreated cornu.
  11. If you encounter resistance due to the previous cryozone, hold the cryoprobe in position and allow the heated tip to melt through the frozen section into the untreated side. Injection of warm saline will facilitate the passage of the cryoprobe.

view of probe placement for second freeze (next to first cryozone)Second freeze cycle

  1. Reconfirm by ultrasound that the cryoprobe is near the fundus and into the untreated cornu.
  2. Depress the minus [-] button to start the second freeze cycle.
  3. Once the cryoprobe tip reaches minus 60°C tension may be relaxed.
  4. Observe the developing cryozone as previously outlined in both longitudinal and transverse view. Observation of the cryozone growth is best viewed through transverse view.
  5. Continue freezing for 6 minutes or until the advancing edge of the cryozone gets within 5 mm of the serosal.
  6. The second cryozone should completely merge with the first cryozone.
  7. Depress the plus (+) (heat button) to begin the heat cycle.
  8. At 20°C, begin rotating the cryoprobe and remove it from the uterus.
  9. Remove the tenaculum from the cervix. Achieve hemostasis of the tenaculum sites if necessary.
  10. Remove the speculum.
  11. The Heat Cycle ends when the display panel reads "Standby." Press Exit and select Yes to "End Procedure."

Post procedure

Have your patient position herself so that she’s fully supported on the exam table.
Provide the patient a sanitary pad for any discharge.
She may want to use the restroom immediately following the procedure. Your staff will be on hand to assist her if she wishes.
Your staff will clean the perineal area following the procedure.
Allow patient to rest comfortably for approximately 15 minutes.
If appropriate, send your patient home with an NSAID or Percocet® for cramping.
Schedule an office follow-up.
Tell your patient she may conduct normal activities as soon as she is comfortable, with the exception of strenuous exercise and sexual activity. She may return to these with your approval.

Post procedure expectations

Setting realistic expectations for your patient is an important part of a successful uterine cryoablation treatment.

Let your patient know the following:

She may experience post-operative cramping similar to menstrual cramps. Recommend NSAIDs for discomfort.
She should schedule a follow-up appointment for two weeks from the procedure date.
She may experience up to four weeks (but usually less) of watery discharge.
She will likely notice reduction or elimination of menstrual bleeding within three months after the cyroablation procedure with “final” results at six months.