FAQ in TRI - Transradial Intervention
Frequently Asked Questions.
RADIFOCUS™ Optitorque™
Heartrail™ II
TR Band™
Glidesheath Slender™
RADIFOCUS™ Guide Wire M
RADIFOCUS™ Optitorque™
What is the difference between the universal catheters (TIG, TIG II and Jacky)?
They are all dedicated catheters for transradial procedures
You can choose the right one for you depending on your preference. More details about each one can be found below.
2: The International Journal of Cardiovascular Imaging (2005). Seong-Man Kim et al DOI 10.1007/s510554-005-0029-8
History
TIG I (4.0) design
・First developed in Japan in 1991. (Tora-no-mon shape: Tora means Tiger in Japanese)
・The shape combines the concepts of JL and JR, and is designed to be able to access both the LCA and the RCA from the right radial artery.
・The secondary curve (↘) is for ensuring minimal injury to the aortic wall when rotating and for adjustment of back-up support when maneuvering.
Jacky & Sarah design
・Developed in Japan. (Named after amine/manga cartoon characters)
・Jacky has a less acute primary curve (○) for better coaxial engagement with inferior angled LCA and RCA.
・Angled catheter tip (↗) prevents dislocation when flushing the catheter.
TIG II design
1. The proximal curve(○) is designed to locate the catheter shaft at the center of the ascending aorta to maneuver right or left easily.
2. The primary curve (╰) is wider than TIG I, which is designed for inferior angled LCA and RCA.
3. Due to 1 & 2 above, the back-up force to the LCA is a little weak, which should be overcome through techniques and shapes.
Variety of TIG Ⅱ
What is the tip length?
Please contact your local Terumo representative for more details.
What is the difference between Jacky and BLK?
Difference between Jacky and BLK
Please select according to your preference!
What are SR and SAL?
SR stands for short; short tip AR and short tip AL.
What is the flow rate of OPTITORQUE™?
4Fr PBS: 19 mL/sec, iohexol: 12 mL/sec @750 psi
5Fr PBS: 32 mL/sec, iohexol: 21 mL/sec @ 1000 psi
6Fr PBS: 37 mL/sec, iohexol: 25 mL/sec @ 1000 psi
Any literatures regarding Optitorque™?
What kind of shapes and curves do you have?
Please contact your local Terumo representative for more details.
What is the difference between JL/JR and CL/CR?
CL/CR have more round curves.
What is the length and without braid?
Please contact your local Terumo representative for more details.
Heartrail™ II
What is the length of the catheter?
It is 100 cm.
What are the differences between JL/JR and IL/IR?
IL/IR are more curved than JL/JR.
Which sizes are available?
5Fr, 6Fr and 7Fr.
*Please contact your local Terumo representative for more details.
What is the meaning of Ikari?
It comes from the name of Dr. Yuji IKARI who devised this shape.
Any literatures regarding Ikari shape?
TR Band™
How does the balloon pressure change over time?
Please refer to the chart below.
What is the range of wrist sizes which we can apply TR Band™ to?
Regular size is for 14-20 cm wrist size patients and large size is for 14-25 cm wrist size patients.
*If you have to apply the band to patients who have thinner or thicker wrist sizes than those listed above, the length of the magic tape overwrapping part may be too short and there is an increased risk of it coming off. Please consider countermeasures, for example, fixing the adjustable fastener in place with a tape.
How long should the device be applied?
Referring to the protocol of a hospital in Japan which uses TR Band™, the standard time is 4 hours. However, the compression time may differ according to the patient's condition and the hospital condition. Please check the puncture site and adjust accordingly.
In the event that the patient complains of pain: confirm there is no bleeding and remove an appropriate volume of air.
In the event that the puncture site is bleeding:
Inject more air until the bleeding stops. (Maximum acceptable air volume is 18 ml in total.)
Recently, there has been a trend of minimizing the compression pressure and compression duration in order to decrease the RAO risks. Various factors such as the patient's blood pressure, anticoagulation and heparin administration affect the hemostasis condition so please manage this carefully while confirming that there is no bleeding.
How tight should the band be fixed on the wrist?
Fix the belt on the wrist with a little space on the ulnar artery side. This may help you to ensure enough space after air injection into the compression balloon. The space on the ulnar artery side can help avoid compression of nerves and the ulnar artery, etc. and thus, it can decrease pain.
→Caution: if the band is fixed too loosely, the compression balloon may slip out from the access site or adequate pressure for hemostasis may not be achieved.
→"Putting a 2.5 mL syringe inside the band on the ulnar artery side" is an example of an easier method to fix the TR Band™ on the wrist.
Why does TR Band™ have two balloons?
Why does TR Band™ have two balloons?
Can TR Band™ be reused?
PRECAUTIONS
- Do not use the TR Band™ Inflator for other purposes than to inflate the TR Band™. It is not designed for other purposes.
- The TR Band™ can be inflated only by using the TR Band™ inflator included in the kit or the TR Band™ Air Volume Regulator. If other devices are used, adequate air compression can not be achieved.
- Depending on the patient’s condition and the degree of balloon pressure, an adverse event including artery occlusion, hypodermic hematoma, hemorrhage, pain, or numbness may occur. Check the progress of the hemostasis and adjust the air pressure accordingly.
- When connecting the TR Band™ inflator included in the kit or TR Band™ Air Volume Regulator to the TR Band™, keep the plunger in place. Releasing the plunger will cause the air to expel from theTR Band™. Loss of air compression may cause bleeding.
- Bleeding could occur if the adjustable fastener comes off during compression. Depending on the patient’s wrist size and the way the device is applied, the adjustable fastener could come off. Fix the adjustable fastener in place with tape if necessary.
- This device has been sterilized by ethylene oxide and is for single use only. Do not resterilize or reuse.
- Do not use this device if the unit package or the product has been damaged or soiled.
- The device should be used immediately after the package and of safely and properly after use.
- Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during storage.
How much is the maximum acceptable air injection volume?
The maximum acceptable injection volume is 18 ml. If this volume is exceeded, it will be painful for patients. It will also cause damage to the pressure confirmation balloon.
Is a gauze necessary between TR Band™ and the access site?
No, this device is sterilized. By direct application, you can confirm the situation of hemostasis easily through the transparent material.
What does TR Band™ stand for?
TR Band stands for Terumo Radial Band.
What should we be careful of when we inject air into the compression balloon?
After injection, quickly remove the syringe. Please make sure to keep the plunger in place with your thumb.
→If the plunger is not kept in place, the air may be forced back into the syringe and the balloon pressure may decrease.
→If the syringe is removed slowly, it may cause air leakage and the balloon pressure may decrease.
PRECAUTIONS
・Do not use the TR Band™ Inflator for other purposes than to inflate the TR Band™. It is not designed for other purposes.
・The TR Band™ can be inflated only by using the TR Band™ inflator included in the kit or the TR Band™ Air Volume Regulator. If other devices are used, adequate air compression can not be achieved.
・Depending on the patient’s condition and the degree of balloon pressure, an adverse event including artery occlusion, hypodermic hematoma, hemorrhage, pain, or numbness may occur. Check the progress of the hemostasis and adjust the air pressure accordingly.
・When connecting the TR Band™ inflator included in the kit or TR Band™ Air Volume Regulator to the TR Band™, keep the plunger in place. Releasing the plunger will cause the air to expel from theTR Band™. Loss of air compression may cause bleeding.
・Bleeding could occur if the adjustable fastener comes off during compression. Depending on the patient’s wrist size and the way the device is applied, the adjustable fastener could come off. Fix the adjustable fastener in place with tape if necessary.
・This device has been sterilized by ethylene oxide and is for single use only. Do not resterilize or reuse.
・Do not use this device if the unit package or the product has been damaged or soiled.
・The device should be used immediately after the package and of safely and properly after use.
・Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during storage.
Does the thickness of the wrist affect the compression?
By adjusting the band to the patient's wrist size, it is possible to compress at almost the same pressure for all patients.
Where should we align the green marker to?
Please align the green marker on the arterial puncture site. Depending on the angle of insertion, there may be a gap between the skin puncture site and arterial puncture site. The compression pressure should be applied to the arterial puncture site.
Glidesheath Slender™
Does the plastic jacketed wire in the Introducer Kit have hydrophilic coating?
No, the plastic jacketed wire in the Introducer Kit does not have hydrophilic coating in order to avoid the risk of the guidewire slipping and falling into the blood vessel.
Are there any papers on spasms?
What is the minimum radial artery diameter that each GSS size can accommodate?
We recommend physicians to use GSS when the radial artery size is larger than the outer diameter (O.D.) of the sheath. The O.D. for each Fr size is as follows:
5Fr GSS: 2.29 mm
6Fr GSS: 2.62 mm
7Fr GSS: 2.95 mm
Can GSS be used for TFI?
No, GSS is limited to use in TRI. This is also written in the IFU. Please use RADIFOCUS™ Introducer ll for TFI.
Can GSS be used even after kinking?
GSS is made from a soft ETFE material, which allows the sheath to revert back to the original position after kinking. Therefore sheath kinking does not impair device insertion. Due to the nature of the material, there is low risk of damage to the vessel wall even if the sheath has been kinked.
RADIFOCUS™ Guide Wire M
Why is this guidewire black?
Due to the use of tungsten (radiopaque material).
What kind of tip shape do you have?
The following types are available: Straight, Angled, 6.0 mm J shape, 1.5 mm J shape, 2.0 mm J shape, 3.0 mm J shape, Double angulation (Bolia curve)
How long is the hydrophilic coating part?
The whole length. / From the distal to the proximal tip.
What is the variation of the outer diameter?
The following types are available: 0.018", 0.025", 0.032", 0.035", 0.038"
What is the variation of the length?
Lengths from 80 cm to 450 cm are available.
What is the material of this guide wire?
Core: Nickel-titanium alloy / Nitinol
Coating: polyurethane with tungsten and hydrophilic polymer
What kind of shaft do you have?
The following types are available: Standard, Half stiff, Stiff