Publicidad
Indications
®
The ENDOPATH
XCEL™ Blunt Tip Trocar has application in thoracic, gynecologic, laparoscopic and
other abdominal procedures to establish a path of entry for minimally invasive instruments.
Contraindications
This device is not intended for use when minimally invasive techniques are contraindicated.
Device Description
The ENDOPATH
®
XCEL
®
Blunt Tip Trocar with OPTIVIEW™ Technology is a sterile, 12 mm diameter
single patient use instrument consisting of a radiolucent sleeve and obturator. The obturator has a blunt
plastic tip which gently moves aside any internal viscera which may be adjacent to the abdominal or
thoracic wall. OPTIVIEW™ Technology reduces the incidence of trocar-induced smudging during camera
reinsertion. The trocar sleeve contains two seals, an outer integrated removable self-adjusting seal that
accommodates instruments ranging from 5 mm to 12 mm in diameter where indicated and an internal seal.
Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the
trocar. An adjustable plug on the outside of the trocar sleeve provides suture tie posts that can be used
to suture the trocar sleeve in place. A stopcock valve is compatible with standard luer lock fittings and
provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is
parallel to the sleeve.
Illustration and Nomenclature (Illustration 1)
1.
Adjustable Plug
7.
Obturator Locking Button (housed in obturator handle)
2.
Suture Tie Posts
8.
Outer Seal
3.
Adjustable Locking Cam
9.
Outer Seal Release Lever
4.
Obturator
10.
Stopcock
5.
Blunt Tip
11.
Trocar Sleeve
6.
Obturator Handle
12.
Blunt Tip Symbol
Instructions for Use
Verify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings
and Precautions).
Prepare the patient in accordance with proper surgical techniques prior to insertion of the trocar.
Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the
1
instrument into the sterile field.
The trocar obturator and sleeve are packaged unassembled. To assemble, remove the protective
2
tip covering from the obturator and trocar sleeve and discard. Assemble the trocar by inserting the
obturator into the trocar sleeve until they lock securely together.
Note: The trocar is packaged with the stopcock in the open position. Close the stopcock before use.
The stopcock is in the closed position when the stopcock lever is parallel to the sleeve.
Create an incision using standard surgical procedure which allows the trocar to be introduced.
3
Note: An inadequate incision may cause increased resistance to insertion, increasing the required
penetration force, and possibly resulting in a loss of control during entry.
Place a finger into the incision to ensure that the free abdominal or thoracic cavity has been entered.
Pass two size 0, Coated Vicryl
®
(polyglactin 910) sutures, one through each fascial edge, and tag
them. Hold the sutures upward and apart.
Insert the trocar into the incision with the adjustable plug secured against the bottom of the trocar
4
sleeve housing. Slide the adjustable plug down the trocar sleeve and into the incision. Pull and wrap
the sutures snugly around the suture tie posts on the adjustable plug. This forces the plug firmly
into the incision to help seal it and minimize gas leakage later in the procedure. Position the desired
amount of trocar sleeve in the abdominal or thoracic cavity by sliding it up or down accordingly.
Once the desired sleeve position has been established, secure the adjustable plug to the sleeve by
pushing down the locking cam. (Illustration 2)
Press the locking buttons to remove the obturator handle assembly, leaving the sleeve in place.
5
(Illustration 3) The internal seal in the sleeve automatically closes as the obturator is withdrawn. The
seal system maintains insufflation in the absence of an instrument in the sleeve.
To insufflate, attach a gas line to the stopcock on the trocar sleeve and open the stopcock. The seal
6
system maintains insufflation in the absence of an instrument in the sleeve.
1
7
For specimen removal during the procedure, the outer seal can be removed by pushing the outer
seal release lever in a counterclockwise direction and lifting off the outer seal. After removal of the
specimen, use a sterile abdominal sponge to remove any bodily fluid or debris that may have been
deposited within the trocar's seal system. (Illustration 4 and Illustration 5) Replace the outer seal on
the trocar. Orient the reducer cap so it is aligned correctly with the top of the trocar. Position the seal
latches over the corresponding holes in the top of the trocar and press down to snap cap in place.
(Illustration 6)
8
Upon completion of the procedure, remove the gas line. Open the stopcock to rapidly deflate the
abdominal cavity.
Warnings and Precautions
•
Minimally invasive procedures should be performed only by persons having adequate training and
familiarity with minimally invasive techniques. Consult medical literature relative to techniques,
complications, and hazards prior to performance of any minimally invasive procedure.
•
Minimally invasive instruments may vary in diameter from manufacturer to manufacturer. When
minimally invasive instruments and accessories from different manufacturers are employed together
in a procedure, verify compatibility prior to initiation of procedure.
•
A thorough understanding of the principles and techniques involved in laser, electrosurgical, and
ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical
personnel and damage to the device or other medical instruments. Ensure that electrical insulation
or grounding is not compromised. Do not immerse electrosurgical instruments in liquid unless the
instruments are designed and labeled to be immersed.
•
Using minimally invasive instruments with a smaller diameter than specified for the blunt tip trocar
may result in desufflation of the abdominal cavity.
•
Although the blunt tip trocar has a blunt tip, care must still be taken, as with all trocars, to avoid
damage to major vessels and other anatomic structures (such as bowel or mesentery). To minimize
the risk of such injury be sure to:
-
Properly position the patient to help displace organs out of the area of penetration;
-
Note important anatomical landmarks;
-
Direct the trocar tip away from the major vessels and structures;
-
Do not use excessive force.
•
Once partial entry has been accomplished, very little pressure may be required to complete entry.
Excessive pressure could cause injury to intra-abdominal or intra-thoracic structures.
•
Use caution when introducing or removing instruments or prosthetic mesh through the trocar sleeve
in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.
Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent
tearing the seal.
•
After removing the blunt tip trocar from the abdominal or thoracic cavity, inspect the site for
hemostasis. If hemostasis is not present, appropriate techniques should be used to achieve
hemostasis.
•
Instruments or devices which come into contact with bodily fluids may require special disposal
handling to prevent biological contamination.
•
Dispose of all opened instruments whether used or unused.
•
This device is packaged and sterilized for single use only. Multiple patient use may compromise the
device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.
How Supplied
The ENDOPATH
®
XCEL
®
Blunt Tip Trocar with OPTIVIEW™ Technology is supplied sterile for single
patient use. Discard after use.
2
Publicidad
