Install Pressure Monitoring Lines; Pressure Test Circuit; Placing The Catheters; Insertion Of Chemofuse® Delivery Catheter - Delcath Systems CHEMOSTAT Mode D'emploi

(c) Attach the female to the male quick connector located by outlet clamp (11).
Position the bubble trap in the bubble trap holder higher than filter cartridges.
(d) Prime venous return line and bubble trap by opening clamps 4, 11 and 9; attach
stopcock to bubble trap and use syringe to aspirate air, as necessary.
E
(e) Close clamp 9 once venous return line and bubble trap are primed to the pouch.
7
8
FILTER FILTER
OUTFLOW OUTFLOW
Ensure That All Air Is Purged From The System Prior To Use In Order To
Delcath

7. Install Pressure Monitoring Lines

Hemofiltration
(a) Select the proper type of pressure monitoring lines based on the model Medtronic
Cartridges
(Chemofilter)
Bio-Medicus pump you have.
(b) Attach pre-pump (to measure negative pressure – pump suction) pressure
monitoring line to stopcock " B" and prime.
FILTER FILTER
Pressure
INFLOW INFLOW
Monitoring
Line
5 6
D
4
C
Bypass
(c) Attach pre-filter (to measure positive pressure – pre-filter) pressure monitoring
Line
line to stopcock " D" and prime.
(d) Attach the pressure monitoring lines to the P1 and P2 ports on the rear of the
Medtronic Bio-Medicus 560 or to the two Pressure Display Boxes (if using older
550 or 540 Bio- Medicus Systems).
(e) Zero the pressure transducers (refer to Pressure Displays or Bio-Console Manual for
details).

8. Pressure Test Circuit

(a) P ressure test circuit by slowly ramping up the pump head speed (RPM) until a
pressure reading of 300 mmHg is achieved on the pressure transducer attached to
the line on Y-connector " D" (pre-filter).
(b) V isually inspect all connections and cartridges to ensure no leaks are present.
Heparinized Saline
WARNING
Avoid An Air Embolism
1
2
A
E
7
8
FILTER FILTER B
OUTFLOW OUTFLOW
10
Delcath
Hemofiltration
Cartridges
Flow Probe
(Chemofilter)
FILTER FILTER
Pressure
INFLOW INFLOW
Monitoring
Line
5
6
D
4
C
Bypass Line
CAUTION: If leak is noted, ensure connections are secure before proceeding.
(c) T urn off pump and close cartridge inlet (5, 6) and outlet (7, 8) clamps. Ensure
bypass line clamp (4) is open.
(d) System is now primed, hydrated, de-bubbled, and ready for use.
(e) Ensure there are two (2) liters of normal saline available for later use.

PLACING THE CATHETERS

9. Insertion of the 10F Venous Return Sheath
(a) Attach the stopcock to the sheath side port tube. Using standard Seldinger
technique (with ultrasound guidance), insert the venous return sheath, into the
internal jugular vein (preferably the right side internal jugular vein). Flush the
sheath with sterile heparinized saline. Close the stopcock. Use of sonographic
guidance and a single anterior wall puncture of the vein are required to avoid
inadvertent carotid artery puncture. If a carotid artery puncture is inadvertently
made, the procedure must be aborted and postponed to a later date.
10. Insertion of the 5F Femoral Arterial Sheath
3
Heparinized Saline
(a) Using Seldinger puncture technique and standard fluoroscopic and arteriographic
techniques, place the 5F Introducer Sheath into the femoral artery. Use of
sonographic guidance and a single anterior wall puncture of the femoral artery
over the femoral head are required so as to assure compressibility of the artery
when the sheath is removed. If a supra-inguinal puncture is inadvertently made,
the procedure must be aborted and postponed to a later date.
11. Insertion of the 18F Venous Sheath
(a) Using Seldinger technique and standard fluoroscopic and angiographic techniques,
place the 18F introducer sheath into the femoral vein after serial dilation with 8
-10F and 12 -14F dilators. Flush the sheath with sterile heparinized saline. Use of
1 2
sonographic guidance and a single anterior wall puncture of the femoral vein over
the femoral head are required so as to assure compressibility of the vein when the
sheath is removed. If a supra-inguinal puncture is inadvertently made, the procedure
A
3
must be aborted and postponed to a later date.
12. Insertion of Chemofuse® Chemo Delivery Catheter
(a) Introduce the Chemo Delivery catheter through the sheath and manipulate it
over a guidewire into the proper hepatic artery. Use coaxial micro-catheter, as
B
necessary.
10
(b) Position the Chemo Delivery catheter (or micro-catheter) in the proper
hepatic artery well beyond the origin of the gastroduodenal artery to deliver
chemotherapeutic agent (melphalan hydrochloride), and affix catheter to the
skin at the groin. During the infusion procedure, a single optimal angiographic
projection of the hepatic artery may be used to periodically document hepatic
Flow Probe
arterial patency and flow.
(c) Connect the Chemo Delivery catheter (or micro-catheter) and maintain catheter
patency by hospital catheter infusion protocols (e.g., infuse heparinized saline: The
concentration of heparin should be 1000 units per 500 mL of normal saline.)
The Catheter Must Be Positioned As Described Above So That Drug Is Infused ONLY
Into The Liver. Perfusion Of Drug Into Any Other Abdominal Organ Or Gastrointestinal
Branches Must Be Avoided As This May Result In Serious Injury Or Death.
13
WARNING