Instructions for Use

UltraGuideCTR™

Intended Use:

UltraGuideCTR is intended to transect the transverse carpal ligament for the treatment of carpal tunnel syndrome.

Indications for Use:

UltraGuideCTR is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

Contraindications:

  • Presence of infection.
  • Distorted anatomy or other process within the carpal tunnel preventing safe and effective transection of the TCL.
  • Presence of condition requiring surgical intervention beyond transection of the TCL.
  • Additionally, in cases in which ultrasound guidance is used, inability to sonographically identify and protect relevant anatomic structures such as the nerves and vessels.

Possible Complications:

Operators should be familiar with the complications of carpal tunnel release using UltraGuideCTR, including but not limited to:

  • Procedure related discomfort.
  • Infection.
  • Wound complications such as delayed healing, scarring or tenderness.
  • Pillar pain.
  • Bruising.
  • Injury to vessels, tendons or other soft tissues.
  • Injury to nerves such as the median nerve.
  • Development of a chronic pain process such as complex regional pain syndrome.
  • Recurrence.
  • Incomplete symptom resolution.
  • Additionally, in cases in which ultrasound guidance is used, inability to complete the carpal tunnel release with ultrasound guidance requiring discontinuation of the procedure.

Warnings:

  • Safe and successful transection of the TCL using UltraGuideCTR is dependent upon appropriate training, knowledge of carpal tunnel anatomy, and careful study and adherence to the surgical technique.  Failure to properly follow the instructions, warnings and precautions may lead to serious surgical consequences or injury to the patient or operator.
  • Inflating the balloons beyond the maximum inflation volume may cause the balloons to rupture before reaching the maximum inflation pressure of 40 psi.
  • Inflating the balloons beyond the maximum inflation pressure may cause the balloons to rupture before reaching the maximum inflation volume.
  • Use of UltraGuideCTR in conjunction with ultrasound guidance should only be performed by operators experienced in ultrasound guided procedures and who are properly trained and familiar with the correct operation of UltraGuideCTR as outlined in this document.
  • The safety and effectiveness of UltraGuideCTR to transect the TCL in cases of recurrent carpal tunnel syndrome has not been established.
  • The cutting blade of UltraGuideCTR is extremely sharp.  Exercise caution to prevent injury.
  • Device misuse, such as excessive prying, may damage the device, resulting in an inability to complete the procedure or potential injury.   
  • If visualization of the device or relevant anatomical structures is impaired during the procedure, DO NOT continue until proper visualization is restored.
  • Following use, the device must be properly discarded as outlined in this document.
  • Do NOT Re-sterilize.  Single Use Only.

Packaging and Sterilization:

  • UltraGuideCTR and syringe are supplied sterile.
  • The Product should be accepted only if the factory packaging arrives intact.
  • Contact Customer Service if the sterile package has been altered or damaged.

Product Users/Use Environment

  • Customers: The device should be used by properly trained health care providers in hospital and clinic settings.
  • Users: The device should be used by a physician, surgeon, or other medical personnel qualified to perform a carpal tunnel release and/or ultrasound guided procedures (herein referred to as the operator).
  • Use Environments: Procedure room in a clinical facility such as an outpatient facility, physician’s office or a hospital.

Precautions:

  • Operators using UltraGuideCTR should be familiar with the surgical technique and the required instrumentation.
  • Operators using UltraGuideCTR in conjunction with ultrasound guidance should be familiar with the use of ultrasound for interventional procedures.
  • Carpal tunnel release using UltraGuideCTR represents a surgical procedure.  Operators and staff should follow appropriate precautions and procedures.
  • The position of the patient’s hand should be controlled during the procedure.  Unwanted hand movement may make the procedure more difficult or result in injury.   

Directions for Using UltraGuideCTR– Ultrasound Guided Technique:

  1. Pre-Operative Planning
    1. See Precautions: Carpal tunnel release using UltraGuideCTR represents a surgical procedure. Operators and staff should follow appropriate precautions and procedures.
  2. Stabilizing the Arm and Sterile Preparation
    1. Operators should stabilize the arm and prepare the sterile field in accordance with standard procedures for mini-open carpal tunnel release.
    2. See Precautions: The position of the patient’s hand should be controlled during the procedure.  Unwanted hand movement may make the procedure more difficult or result in injury.   
  3. Delivering Local Anesthesia
    1. As noted previously, operators should provide anesthesia in accordance with their usual practice when performing Mini-Open carpal tunnel release.
  4. UltraGuideCTR should be prepared for use as described for the technique using Ultrasound Guided Technique:
    1. Prepare UltraGuideCTR.
    2. Check UltraGuideCTR before use.
    3. Test UltraGuideCTR tip in the “No-Go” slot.
  5. Exposing the TCL
    1. Complete the operator preferred surgical exposure for a Mini-Open carpal tunnel release.  Identify the proximal and distal margins of the TCL, as well as the superficial palmar arterial arch lying distal to carpal tunnel.
    2. Further expose the TCL using retractors as necessary.
  6. Placing UltraGuideCTR Into the Carpal Tunnel
    1. Expose the distal antebrachial fascia between the proximal and distal wrist creases.  Create a small incision with a scalpel blade through the antebrachial fascia, ulnar to the palmaris longus tendon and along a line parallel to the radial aspect of the ring finger (i.e., in the transverse safe zone). 
    2. Palpate the hook of the hamate, which identifies the ulnar extent of the distal carpal tunnel region (i.e. the transverse safe zone, TSZ).
    3. Under direct visualization, place UltraGuideCTR directly under the proximal aspect of the TCL and just radial to the hook of the hamate. UltraGuideCTR should be placed under the TCL so that its blunt tip and shaft are in direct contact with the undersurface of the TCL at all times.  
    4. Advance UltraGuideCTR distally within the carpal tunnel, along the anticipated line of TCL transection.  UltraGuideCTR should always be in contact with the undersurface of the TCL until it reaches beyond the distal extent of the TCL. Directly visualize the blunt distal tip passing beyond the TCL and engaging the distal TCL. Position the distal tip so that the cutting knife (TCL Blade) will engage the distal TCL upon deployment. Note the relationship of the distal tip to the superficial palmar arterial arch to avoid injury.
      NOTE: During the procedure, UltraGuideCTR should remain approximately parallel to the patient’s forearm so that the tip is perpendicular to the wrist crease. The patient’s hand should remain slightly extended, supinated and in neutral radial-ulnar deviation.
    5. Once proper positioning is confirmed, slide the axial depth indicator to position it against the forearm tissues.
  7. Cutting the Transverse Carpal Ligament Using UltraGuideCTR
    See Warnings: If visualization of the device or relevant anatomical structures is impaired during the procedure, DO NOT continue until proper visualization is restored. If unable to restore adequate visualization, discontinue the procedure. Ensure that the TCL Blade is in its proximal or distal recessed position and the Stealth MicroGuard balloons are deactivated prior to device removal
    1. After confirming proper placement of UltraGuideCTR within the ulnar aspect of the carpal tunnel (i.e., the TSZ) activate the Stealth MicroGuard balloons by depressing the balloon activation lever towards the handle.
      CAUTION:  Attempting to deploy the TCL Blade without first activating the Stealth MicroGuard balloons will damage UltraGuideCTR and may result in injury.
      CAUTION:  Once the Stealth MicroGuard balloons are deployed, the TCL Blade is active.  Exercise caution to avoid unwanted exposure of the TCL Blade prior to initiating TCL transection, which may result in injury to the patient.
    2. Following balloon activation, re-confirm proper positioning of UltraGuideCTR within the carpal tunnel.
    3. Deploy the TCL Blade by moving the slide button proximal to transect the TCL from distal to proximal until the TCL Blade passes into its proximal, recessed position.
      NOTE: If a balloon leak is detected, ensure that the TCL Blade is completely located in either its proximal or distal recessed position, deflate the Stealth MicroGuard balloons, and carefully remove the device. Following removal, confirm that the balloons are not operating properly.  If the balloons are not operating properly, then obtain a new device to finish procedure.
    4. Once the TCL is transected the TCL should be probed to ensure a complete release. Probing may be completed using UltraGuideCTR tip or a blunt tipped probe or elevator. If UltraGuideCTR will not be used for probing, carefully remove UltraGuideCTR following the instructions below (Removing UltraGuideCTR) and probe the TCL with the alternative instrument.  If UltraGuideCTR will be used for probing, move the slide button distally to replace the TCL Blade completely into its distal recessed position, deflate the Stealth MicroGuard balloons, and proceed with probing
    5. If complete TCL transection is confirmed, carefully remove the instrument or device (if probing with UltraGuideCTR device follow the instructions below Removing UltraGuideCTR). If incomplete transection is suspected, additional attempts at TCL transection may be performed as described below (Suspected Incomplete TCL Transection).
  8. Suspected Incomplete Transection
    1. If incomplete TCL transection is suspected, additional attempts at TCL transection may be performed. 
    2. Ensure that the TCL Blade is completely in its distal, recessed position.
    3. Reposition the device in the carpal tunnel as previously described.
    4. Confirm the position of UltraGuideCTR within the carpal tunnel relative to surrounding anatomy. Note that the regional anatomy may have been significantly altered by the previously attempted TCL transection(s). 
    5. Once UltraGuideCTR is accurately repositioned, reactivate the Stealth MicroGuard balloons and re-check the position of the device relative to surrounding structures. Following confirmation, repeat the steps to transect the TCL as previously described. See Warnings: If visualization of the device or relevant anatomical structures is impaired during the procedure, DO NOT continue until proper visualization is restored. If unable to restore adequate visualization, discontinue the procedure. Ensure that the TCL Blade is in its proximal or distal recessed position and the Stealth MicroGuard balloons are deactivated prior to device removal.
    6. Following repeat attempted TCL transection, re-probe the TCL as previously described to assess for complete TCL transection. 
  9. Removing UltraGuideCTR
    1. After confirming that the TCL Blade is located completely in either its proximal or distal recessed position, deflate the Stealth MicroGuard balloons and carefully remove UltraGuideCTR.
      NOTE:  If Stealth MicroGuard balloon deflation does not occur when the balloon activation lever is released, the operator may manually deflate the balloons by connecting the sterile filling syringe to the Luer-Lock valve and pulling back on syringe plunger.  This will release the pressure in the balloons and manually deflate them. The blade may still be active, ensure the blade stays in the proximal or distal recessed position.  This method should only be used if the deflation lever fails to deflate the balloons when de-activated.
    2. Following device removal, inspect the device to ensure that it is intact.
  10. Wound Closure and Post-operative Care
    1. See Precautions: Carpal tunnel release using UltraGuideCTR represents a surgical procedure.  Operators and staff should follow appropriate precautions and procedures.
    2. Wound closure and care, as well as post-operative rehabilitation, should be performed according to the operator preferred protocol for Mini-Open carpal tunnel release.

Directions for Using UltraGuideCTR – Mini-Open Technique:

  1. Pre-Operative Planning
    1. See Precautions: Carpal tunnel release using UltraGuideCTR represents a surgical procedure. Operators and staff should follow appropriate precautions and procedures.
  2. Stabilizing the Arm and Sterile Preparation
    1. Operators should stabilize the arm and prepare the sterile field in accordance with standard procedures for mini-open carpal tunnel release.
    2. See Precautions: The position of the patient’s hand should be controlled during the procedure.  Unwanted hand movement may make the procedure more difficult or result in injury.   
  3. Delivering Local Anesthesia
    1. As noted previously, operators should provide anesthesia in accordance with their usual practice when performing Mini-Open carpal tunnel release.
  4. UltraGuideCTR should be prepared for use as described for the technique using Ultrasound Guided Technique:
    1. Prepare UltraGuideCTR.
    2. Check UltraGuideCTR before use.
    3. Test UltraGuideCTR tip in the “No-Go” slot.
  5. Exposing the TCL
    1. Complete the operator preferred surgical exposure for a Mini-Open carpal tunnel release.  Identify the proximal and distal margins of the TCL, as well as the superficial palmar arterial arch lying distal to carpal tunnel.
    2. Further expose the TCL using retractors as necessary.
  6. Placing UltraGuideCTR Into the Carpal Tunnel
    1. Expose the distal antebrachial fascia between the proximal and distal wrist creases.  Create a small incision with a scalpel blade through the antebrachial fascia, ulnar to the palmaris longus tendon and along a line parallel to the radial aspect of the ring finger (i.e., in the transverse safe zone). 
    2. Palpate the hook of the hamate, which identifies the ulnar extent of the distal carpal tunnel region (i.e. the transverse safe zone, TSZ).
    3. Under direct visualization, place UltraGuideCTR directly under the proximal aspect of the TCL and just radial to the hook of the hamate. UltraGuideCTR should be placed under the TCL so that its blunt tip and shaft are in direct contact with the undersurface of the TCL at all times.  
    4. Advance UltraGuideCTR distally within the carpal tunnel, along the anticipated line of TCL transection.  UltraGuideCTR should always be in contact with the undersurface of the TCL until it reaches beyond the distal extent of the TCL. Directly visualize the blunt distal tip passing beyond the TCL and engaging the distal TCL. Position the distal tip so that the cutting knife (TCL Blade) will engage the distal TCL upon deployment. Note the relationship of the distal tip to the superficial palmar arterial arch to avoid injury.
      NOTE: During the procedure, UltraGuideCTR should remain approximately parallel to the patient’s forearm so that the tip is perpendicular to the wrist crease. The patient’s hand should remain slightly extended, supinated and in neutral radial-ulnar deviation.
    5. Once proper positioning is confirmed, slide the axial depth indicator to position it against the forearm tissues.
  7. Cutting the Transverse Carpal Ligament Using UltraGuideCTR
    See Warnings: If visualization of the device or relevant anatomical structures is impaired during the procedure, DO NOT continue until proper visualization is restored. If unable to restore adequate visualization, discontinue the procedure. Ensure that the TCL Blade is in its proximal or distal recessed position and the Stealth MicroGuard balloons are deactivated prior to device removal
    1. After confirming proper placement of UltraGuideCTR within the ulnar aspect of the carpal tunnel (i.e., the TSZ) activate the Stealth MicroGuard balloons by depressing the balloon activation lever towards the handle.
      CAUTION:  Attempting to deploy the TCL Blade without first activating the Stealth MicroGuard balloons will damage UltraGuideCTR and may result in injury.
      CAUTION:  Once the Stealth MicroGuard balloons are deployed, the TCL Blade is active.  Exercise caution to avoid unwanted exposure of the TCL Blade prior to initiating TCL transection, which may result in injury to the patient.
    2. Following balloon activation, re-confirm proper positioning of UltraGuideCTR within the carpal tunnel.
    3. Deploy the TCL Blade by moving the slide button proximal to transect the TCL from distal to proximal until the TCL Blade passes into its proximal, recessed position.
      NOTE: If a balloon leak is detected, ensure that the TCL Blade is completely located in either its proximal or distal recessed position, deflate the Stealth MicroGuard balloons, and carefully remove the device. Following removal, confirm that the balloons are not operating properly.  If the balloons are not operating properly, then obtain a new device to finish procedure.
    4. Once the TCL is transected the TCL should be probed to ensure a complete release. Probing may be completed using UltraGuideCTR tip or a blunt tipped probe or elevator. If UltraGuideCTR will not be used for probing, carefully remove UltraGuideCTR following the instructions below (Removing UltraGuideCTR) and probe the TCL with the alternative instrument.  If UltraGuideCTR will be used for probing, move the slide button distally to replace the TCL Blade completely into its distal recessed position, deflate the Stealth MicroGuard balloons, and proceed with probing
    5. If complete TCL transection is confirmed, carefully remove the instrument or device (if probing with UltraGuideCTR device follow the instructions below Removing UltraGuideCTR). If incomplete transection is suspected, additional attempts at TCL transection may be performed as described below (Suspected Incomplete TCL Transection).
  8. Suspected Incomplete Transection
    1. If incomplete TCL transection is suspected, additional attempts at TCL transection may be performed. 
    2. Ensure that the TCL Blade is completely in its distal, recessed position.
    3. Reposition the device in the carpal tunnel as previously described.
    4. Confirm the position of UltraGuideCTR within the carpal tunnel relative to surrounding anatomy. Note that the regional anatomy may have been significantly altered by the previously attempted TCL transection(s). 
    5. Once UltraGuideCTR is accurately repositioned, reactivate the Stealth MicroGuard balloons and re-check the position of the device relative to surrounding structures. Following confirmation, repeat the steps to transect the TCL as previously described. See Warnings: If visualization of the device or relevant anatomical structures is impaired during the procedure, DO NOT continue until proper visualization is restored. If unable to restore adequate visualization, discontinue the procedure. Ensure that the TCL Blade is in its proximal or distal recessed position and the Stealth MicroGuard balloons are deactivated prior to device removal.
    6. Following repeat attempted TCL transection, re-probe the TCL as previously described to assess for complete TCL transection. 
  9. Removing UltraGuideCTR
    1. After confirming that the TCL Blade is located completely in either its proximal or distal recessed position, deflate the Stealth MicroGuard balloons and carefully remove UltraGuideCTR.
      NOTE:  If Stealth MicroGuard balloon deflation does not occur when the balloon activation lever is released, the operator may manually deflate the balloons by connecting the sterile filling syringe to the Luer-Lock valve and pulling back on syringe plunger.  This will release the pressure in the balloons and manually deflate them. The blade may still be active, ensure the blade stays in the proximal or distal recessed position.  This method should only be used if the deflation lever fails to deflate the balloons when de-activated.
    2. Following device removal, inspect the device to ensure that it is intact.
  10. Wound Closure and Post-operative Care
    1. See Precautions: Carpal tunnel release using UltraGuideCTR represents a surgical procedure.  Operators and staff should follow appropriate precautions and procedures.
    2. Wound closure and care, as well as post-operative rehabilitation, should be performed according to the operator preferred protocol for Mini-Open carpal tunnel release.

Disposal:

UltraGuideCTR should be disposed of in accordance with organizational policies and guidelines for sharps disposal.

Storage: Store the device in a cool, dry place.  

Environmental ConditionsOperationStorage and Transport
Temperature5°C to 40°C-35°C to 60°C
HumidityUp to 85% at 5°C and 90% at 40°Up to 90%

Symbols Library:

Do Not Re-useDo not use if damaged
Use byConsult Instructions for Use
Catalog NumberTemperature Limit
ManufacturerFor Prescription Use Only
Sterilized using radiationBatch Code
Keep dryKeep away from sunlight
Do not resterilize  

Manufactured for:

Sonex Health
950 Blue Gentian Road, Suite 200
Eagan, MN 55121
T: 1-888-518-8780
sonexhealth.com
Version 2020/08

560-08-318396-01 Rev K

SX-One MicroKnife® has been renamed UltraGuideCTR. The device, intended use, indications for use, and clinical data regarding the safety and effectiveness are the same.