|
 |
 |
|
 |
Developed for the treatment of mitral valve stenosis, the Inoue-Balloon Catheter is indicated for Percutaneous Transvenous Mitral Commissurotomy (PTMC) in patients with mitral valvular stenosis, resulting primarily from commissural fusion of the mitral valve cusps. Published data from observational and randomized studies have provided evidence that physicians should consider PTMC as a treatment choice for patients with favorable valve anatomy.(1),(2),(3) The PTMC procedure is one of several methods for treating symptomatic mitral stenosis. Alternative methods which may be considered include: medical therapy, surgical commissurotomy, mitral valve repair and mitral valve replacement. |
INOUE-BALLOON Catheter
Product Description
Indications
|
The Inoue-Balloon Catheter is manufactured of polyvinyl chloride with a balloon attached to the distal end. The balloon is two latex layers between which is polyester micromesh. The catheter is supplied in a 12F diameter with a length of 70 cm; the length of each balloon is 2.5 cm (un-stretched). Two proximally positioned stopcocks accomplish balloon inflation and catheter venting. A stainless steel tube is used to stretch and slenderize the balloon prior to insertion and a 14F tapered dilator enlarges the interatrial opening. The stainless steel stylet and guidewire are employed to guide the catheter inside the heart and blood vessels. A syringe is used to manually inflate the balloon and balloon diameter is measured with a caliper (ruler).
The balloon design exhibits five uniquely different inflation stages [See Figure]. Radiopaque dilute contrast medium is injected to achieve inflation. Changing the volume of dilute contrast medium injected changes inflation stage. These stages are described below.
Product Selection
The balloon diameter size is chosen on the basis of the patient's weight, height, and body surface area, as well as the estimated mitral valve area as determined during cardiac catheterization and/or non-invasive preoperative studies. The catalog number indicates the maximum expandable balloon diameter size.
|
|
Stage 1:
Balloon completely deflated
Allows catheter advancement and passage through the atrial septum. |
|
Stage 2:
Distal portion partially inflated
When a small volume of dilute contrast medium is injected, the distal portion of the balloon inflates first. The balloon may float across the mitral valve, like a thermodilution catheter. |
|
Stage 3:
Distal portion completely inflated
When a larger volume of dilute contrast is injected, the distal portion inflates completely. This aids in seating the balloon on the valve. |
|
Stage 4:
Hourglass shape
A latex band placed at the center of the balloon constricts inflation. Consequently, when additional dilute contrast medium is injected, the balloon shape resembles an hourglass. This unique shape centers the balloon on the valve and prevents migration. |
|
Stage 5:
Full Inflation
Further injection will inflate the balloon to its full extent. The force of this expansion is used to achieve valvuloplasty. |
|
|
|
