Merit Medical HeartSpan STEERABLE SHEATH INTRODUCER Gebrauchsanweisung Seite 3

of the HeartSpan needle advances through the sheath/
dilator assembly.
• During insertion, use caution to avoid excessive bends
in the device, which could inhibit advancement of the
needle and result in inadvertent needle puncture of the
dilator/sheath assembly.
• During insertion, always use the stylette to facilitate
HeartSpan needle passage through the dilator / sheath
assembly. (Failure to use the stylette could inhibit needle
advancement, and could result in inadvertent puncture
of the dilator/sheath assembly or skiving of material from
the inner surface of the dilator).
• Remove components and make catheter exchanges
slowly to minimize the potential for creating a vacuum in
the sheath.
• After the sheath is inserted into the vasculature and the
dilator is removed, aspirate prior to flushing or infusion
until steady blood return is achieved.
• All fluid infusion should be through the sideport.
• Because thrombus could accumulate in or on the sheath
tip during the procedure, aspirate when moving the
dilator or catheter.
• To minimize embolic risk, either provide a continuous
infusion of heparinized solution or periodically aspirate
and flush through the sideport while the sheath is
positioned in the vasculature.
• If resistance is met when advancing or withdrawing
the guide wire or introducer, determine the cause and
perform a corrective action before continuing with the
procedure.
• Indwelling intracardiac introducer sheaths should always
be supported with a catheter, dilator, or electrode.
• Do not manipulate the sheath within the heart without a
device extending from its distal tip.
USE STERILE TECHNIQUE
Suggested Procedure
NOTE: Typical variations may occur within these steps,
depending on available capabilities and operator
preference. See OPTIONAL steps below.
1. COMPONENT PREPARATION AND ASSEMBLY
Preparation requires the following Items:
» One HeartSpan sheath and dilator.
» One HeartSpan transseptal needle, with a mating
stylette.
» One guide wire with "J" tip.
» Syringes for aspiration and flushing.
» Sterile heparinized saline.
» OPTIONAL: One 3-way rotating stopcock
• Flush the dilator and sheath with sterile heparinized
saline.
• Position the handle of the sheath stopcock so that it is in
the OFF position. (The OFF marking should point toward
the sideport tube.)
• Fully insert the dilator into the sheath.
• Prepare the HeartSpan transseptal needle.
• Remove the stylette from the HeartSpan needle and flush
the needle with sterile heparinized saline.
• Re-insert the stylette into the HeartSpan needle and lock
it onto the hub.
• Insert the HeartSpan needle and stylette into the sheath/
dilator.
Note: due to the internal stop feature of the dilator, there
will be a gap between the dilator hub and the HeartSpan
needle hub.
• Withdraw the HeartSpan needle assembly until the tip of
the stylette is just within the tip of the dilator.
• Measure the distance between the HeartSpan needle hub
and the dilator hub. Record this measurement for use
during the procedure.
CAUTION: It is critical to maintain this distance between
the HeartSpan needle hub and the dilator hub during the
procedure, to ensure that the tip of the HeartSpan needle
assembly does not protrude from the dilator tip until it is
deployed for transseptal crossing.
OPTIONAL: A secondary measurement can be performed
to establish the distance between the HeartSpan needle
hub and the dilator hub when the HeartSpan needle tip
is just inside the tip of the dilator (without the stylette
403194001MLP_001_heart_span_steerable_IFU.indd 3
inserted).
• Remove the HeartSpan needle from the dilator.
• Remove the stylette from the HeartSpan needle and
flush the HeartSpan needle again. Reinsert and lock the
stylette onto the HeartSpan needle hub. Flush the dilator
again.
• This completes component preparation and assembly.
2. ADVANCEMENT OF SHEATH/DILATOR ASSEMBLY INTO
SUPERIOR VENA CAVA
• Obtain femoral venous access (right femoral preferred).
• OPTIONAL: A larger bore introducer sheath may be left
in place to maintain access for exchanges and hemostasis.
If used, choose a sheath 2½ French sizes larger than the
HeartSpan introducer.
• Introduce a "J" tip guide wire into the superior vena cava.
NOTE: 0.038" is the maximum guide wire diameter that can
be used with the HeartSpan dilator.
• Insert the sheath and dilator assembly over the guide
wire and advance the assembly into the superior vena
cava (SVC). Once the dilator tip is in the SVC, make sure
the tip is pointed medially.
3. POSITIONING OF THE NEEDLE/STYLETTE ASSEMBLY
INSIDE THE SHEATH/DILATOR ASSEMBLY
• Remove the guide wire from the dilator.
• Aspirate and flush the dilator with clean heparinized
saline, ensuring that no air enters the bloodstream.
• Partially withdraw the dilator from the sheath by a
distance sufficient to accommodate the HeartSpan needle
curve. This will facilitate passage of the HeartSpan needle
curve through the dilator and sheath hubs.
• Confirm that the stylette is locked onto the hub of the
HeartSpan needle. Then insert the HeartSpan needle
into the dilator, allowing the needle to rotate freely as it
advances.
• After the HeartSpan needle curve is advanced beyond the
hemostasis valve portion of the sheath, reconnect the
sheath and dilator by retracting the sheath back over the
dilator, while maintaining the position in the SVC. (DO
NOT advance the dilator into the sheath.)
• Advance the HeartSpan needle and stylette until the
distance between the dilator and HeartSpan needle hubs
is the same as the distance previously measured during
COMPONENT PREPARATION AND ASSEMBLY.
• Remove the stylette and set it aside. (Do not discard it.)
• OPTIONAL: The HeartSpan needle may be advanced
slightly. Do not exceed the secondary measurement of
the distance between the HeartSpan needle and dilator
hubs. (See "COMPONENT PREPARATION AND ASSEMBLY"
section above.)
• Attach a syringe to the HeartSpan needle hub and
aspirate until blood return is observed. Discard the
syringe.
NOTE: The use of a slip-tip (non·Luer) syringe may prevent
air aspiration.
• Flush the HeartSpan needle with clean heparinized
saline, ensuring that no air enters the bloodstream. Close
the needle stopcock.
• OPTIONAL: Attach a syringe with radiopaque contrast
media to the HeartSpan needle stopcock. After aspirating
the needle until blood return is observed, load the
HeartSpan needle with the contrast media under
fluoroscopic guidance.
• OPTIONAL: Connect a pressure monitoring line to the
HeartSpan needle stopcock.
• OPTIONAL: Use a standard 3-stopcock manifold setup to
connect contrast, pressure, and flushing lines.
4. FOSSA OVALIS ENGAGEMENT
• Visualize and identify anatomic landmarks. Set the
fluoroscopy unit to an appropriate angle, parallel to the
plane of the mitral valve and orthogonal to the plane of
the septum. This will typically be LAO, approximately 30°
to 40°.
• OPTIONAL: Placement of catheters in the coronary
sinus (CS) and His positions can assist in identification of
anatomic landmarks. In the appropriate LAO view, the CS
catheter can be seen in profile. In the appropriate RAO
view, the His catheter will appear in profile. The fossa
ovalis is located at or slightly below the His catheter, and
superior and posterior to the coronary sinus ostium.
• OPTIONAL: Placement of a pigtail catheter in the
non-coronary cusp of the aortic root can facilitate the
identification of anatomic landmarks.
• OPTIONAL: Observe the pressure waveform being
recorded through the HeartSpan transseptal needle.
Adjust the HeartSpan needle hub so that the needle is
perpendicular to the fossa ovalis (typically between 3:00
and 5:00, as viewed from the foot end of the patient).
• Confirm that the needle tip is inside the dilator by
fluoroscopy and previous measurement of the distance
between the HeartSpan needle and dilator hubs.
• After confirming that the tip of the HeartSpan needle
is within the dilator, drag the assembly slowly while
preventing any relative movement of the assembly
components. It is critical to maintain the previous
orientation of the HeartSpan needle hub.
• Observe the dilator tip for medial (or rightward)
movement during the drag, indicating that the tip has
engaged the fossa ovaIis.
• OPTIONAL: If pressure is being monitored, note that
the pressure through the HeartSpan needle will not be
accurate at this point, since the tip is contacting the fossa
ovalis.
5. FOSSA OVALIS PUNCTURING WITH THE
TRANSSEPTAL NEEDLE
CAUTION: Confirm the correct location of the needle on the
fossa ovalis before advancing the needle.
• Once the correct location is confirmed, advance the
HeartSpan needle across the interatrial septum.
• OPTIONAL: If pressure is being monitored, entry into the
left atrium is confirmed when the pressure tracing shows
a left atrial pressure waveform.
• OPTIONAL: Left atrial access can be confirmed with
contrast injections.
• If there is any resistance to needle advancement, re-
evaluate the anatomic landmarks.
CAUTION: If pericardial or aortic entry occurs, do not
advance the dilator over the HeartSpan needle. If the
needle has penetrated the pericardium or aorta, it must be
withdrawn. Monitor vital signs closely.
6. ADVANCEMENT OF THE SHEATH/DILATOR ASSEMBLY
• While maintaining a fixed needle position, advance the
sheath/dilator assembly over the HeartSpan needle.
7. ADVANCEMENT OF THE SHEATH OVER THE DILATOR
AND NEEDLE INTO THE LEFT ATRIUM
• Withdraw the HeartSpan needle until its tip is just inside
the dilator tip. Maintain the position of the needle and
dilator across the septum.
• With the dilator in a fixed location, advance the sheath
over the dilator.
8. WITHDRAWAL OF THE HEARTSPAN TRANSSEPTAL
NEEDLE AND DILATOR.
CAUTION: There is a risk of air embolization when
withdrawing objects from the sheath. Take precautions to
prevent air infiltration.
• Disconnect any attachments to the HeartSpan needle
hub.
• Withdraw the HeartSpan needle from the dilator.
Immediately attach a syringe to the dilator and aspirate.
Continue aspirating blood while holding the sheath
in position and withdrawing the dilator. Confirm the
presence of arterial blood.
• Once the dilator is removed, aspirate blood through the
sideport of the sheath, and then flush it with heparinized
saline, taking care to prevent air bubbles.
• The sheath is now in position within the left atrium.
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