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Cuff suturing
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Suture techniques may vary according to the preference of the implanting surgeon and the anatomy of
the patient. The medical literature reports several preferred suturing methods.
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Sutures should be placed in the outer half of the cuff, particularly on the AP models. Deep needle
placement will contact the strengthening band inside the cuff and impede smooth placement of
sutures.
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After sutures are placed in the valve cuff and the valve is seated in the tissue annulus, release the
valve from the valve holder. Slide a scalpel down the holder slot to cut the green suture and release
the valve holder. The green suture and valve holder will remain attached as the handle rotator is
carefully withdrawn. The suture knots can be tied at this point. Long suture ends must be avoided.
Caution: Testing of leaflet motion must only be done with the enclosed blue leaflet actuator. Use of
another instrument may damage the valve. If the leaflets do not move freely due to contact with tissue, the
valve orifice may be rotated to a more optimal position. Rotate the orifice only after the suture knots have
been tied, securing the cuff to the tissue annulus.
Rotatability
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The valve orifice and leaflets may be rotated in situ by using the handle rotator supplied in the
package. Before implanting the device, check freedom of rotation by holding the valve cuff and gently
turning the valve holder and handle rotator. Each valve size and model has a specific rotator. If
desired, carefully remove the rotator from the handle by turning the rotator counterclockwise. The
rotator seats properly into the valve orifice when the radial ridge on the handle side of the rotator head
is aligned with the straight edge of the leaflets. The rotator head is designed to contact the flat
surfaces of the orifice near the pivot areas. The orifice may be rotated in a clockwise or
counterclockwise direction. After orientation of the valve orifice in the patient's annulus, leaflet mobility
may be determined with the blue leaflet actuator.
Caution: Use only the rotator supplied with the device. Do not use any other instrument to rotate the
valve. Use of instruments other than those provided may cause damage to the orifice and leaflets and may
result in valve malfunction.
Caution: Exercise extreme care when handling the valve holder assembly to avoid structural damage to
the valve. Inspect each accessory before each use. Do not use cracked or damaged accessories.
7. Postoperative information
7.1. Anticoagulation
The medical literature indicates that patients implanted with mechanical heart valves should be routinely
maintained on anticoagulants to reduce the risk of valve thrombosis and thromboembolism.
7.2. Diagnostic imaging
The Medtronic Open Pivot heart valve provides excellent x-ray images due to the radiopaque
strengthening band around the orifice and 20% tungsten in each leaflet substrate.
7.3. MRI safety information
Nonclinical testing has demonstrated the Medtronic Open Pivot heart valve is MR conditional. A patient
with this device can be safely scanned immediately after implantation in an MR system meeting the
following conditions:
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Static magnetic field of 1.5 T or 3 T
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Maximum spatial field gradient of 2500 gauss/cm or less
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Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of ≤ 2 W/kg
(Normal Operating Mode)
Under the scan conditions defined above, the Medtronic Open Pivot heart valve is expected to produce a
maximum temperature rise of less than 1.8°C after 15 minutes of continuous scanning.
Models 500 and 501:
In nonclinical testing, the image artifact caused by the device extends approximately 15 mm from the
Medtronic Open Pivot heart valve when imaged with a gradient echo pulse sequence and 3 T MRI system.
Model 505:
In nonclinical testing, the image artifact caused by the device extends approximately 30 mm from the
Medtronic Open Pivot heart valve when imaged with a gradient echo pulse sequence and 3 T MRI system.
8. How supplied
8.1. Packaging
The Medtronic Open Pivot heart valve is packaged in sterile transparent double barrier trays. The valve is
premounted on a holder and attached to a handle rotator. All package labeling and handle rotator
accessories are color-coded and marked:
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Aortic – green
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Mitral – red
The valve package (Figure 4) includes:
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Outer tray
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Inner tray
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Inner tray retainer
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Valve, valve holder, handle rotator assembly
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Instructions for Use
20
Instructions for Use
English
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