1. Field of the Invention
The present invention generally relates to a device for performing an intracardiac transseptal puncture procedure. More specifically, the present invention relates to a percutaneous device for making a transseptal puncture in the atrial septum of the heart. In particular, the present invention relates to devices and methods for puncturing the atrial septum vis the percutaneous route. That is for gaining access to the left atrium through the right atrium for diagnostic or therapeutic purposes.
2. Prior Art
Septal puncture through an intact atrial septum from the right atrium to the left atrium is often necessary. This is traditionally performed using rigid, long needles, such as Brockenbrough or Ross needles.
Another device that is specifically designed for the purpose of performing a septal puncture is illustrated in FIG. 1. This drawing is a plan view of the prior art transseptal puncture device 10 described in U.S. patent application Pub. No. 2015/0173794 to Kurth et al. This device is commercially available from Pressure Products Medical Supplies Inc. as the SafeSept® Transseptal Guidewire. The prior art transseptal puncture device includes a dilator 12 providing a lumen 14 axially disposed along a longitudinal axis. The dilator 12 has a blunt distal end 16 defining an opening 18 in open communication with the lumen 14. A guidewire 20 is axially disposed within the lumen of the dilator 12. A transcutaneous intravascular sheath 22 is also shown. The sheath 22 provides a conduit through which the transseptal puncture device 10 passes from outside the patient's body through a vessel, for example, the femoral vein, through the inferior vena cava to the right atrium. A control handle 24 is schematically depicted at the distal end 26 of the sheath 22.
As further shown in FIG. 1, the prior art guidewire 20 has a constant diameter through a major portion of its length. This constant diameter portion begins at the proximal end of the guidewire and is indicated by numerical designation 28. The constant diameter portion forms into a piercing head 30 having a conical taper extending to a distal pointed tip 32. The taper of the piercing head 30 is similar to the shape of a pencil head.
A drawback of the prior art transseptal puncture device 10 is that when the guidewire 20 is used in an intracardiac transseptal puncture procedure, the conical-shaped taper of the piercing head 30 extending to the pointed tip 32 tends to puncture the septum wall 34 (FIG. 2) leaving the body tissue with a somewhat jagged cut, as indicated by numerical designation 36. Further, the tissue comprising the septum wall 34 is relatively pliable and supple, which means that the tissue readily relaxes back to its original shape. After the guidewire 20 is removed from the puncture site, the opening in the septum wall tends to close back to a diameter that is significantly less than the maximum diameter of the constant diameter portion 28 of the guidewire 20. This can make it difficult to move a catheter or other cardiac instrument through the pierced opening in the septum wall 34.
In that respect, while the prior art SafeSept® Transseptal Guidewire is suitable for use in performing an intracardiac transseptal puncture procedure, there is a need for an improved transseptal puncture device that when used to puncture the septum wall not only cuts the body tissue in a clean knife-like manner, but leaves an opening having a diameter that is substantially similar to the maximum diameter of the guidewire.
The transseptal puncture device of the present invention fulfills these needs.