Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-10-14
2001-06-12
O'Connor, Cary (Department: 3736)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C600S585000
Reexamination Certificate
active
06245054
ABSTRACT:
BACKGROUND OF THE INVENTION
Historically, left heart catheterization has been most commonly performed by the retrograde aortic approach. The transseptal approach, which involves needle perforation of the atrial septum, was less often used due to risk of perforating the right or left atrial free walls or aorta. The traditional transseptal approach is described in De Ponti, et al., “Trans-septal catheterization for radiofrequency catheter ablation of cardiac arrhythmias”, European Heart Journal (1998), Vol. 19, pages 943-50, the disclosure of which is incorporated herein by reference.
In recent years, however, use of transseptal technique has gained more widespread use with the introduction of technical modifications and products in the interventional area that have improved the safety and ease of performing the procedure, and the desire to ablate left-sided arrhythmiogenic substrates. Guiding sheaths are of particular benefit to physicians in performing left-sided ablation procedures as the sheaths provide stable means of delivering and supporting the deflectable ablation catheter on the left side. When a guiding sheath is used, direct access to the mitral annulus and the anterior and posterior walls can be attained. In addition, the long procedure times associated with the treatment of more complex arrhythmias, such as atrial fibrillation, necessitate the use of guiding sheaths to provide stability and directional control of the ablation catheter.
In some cases, a tachycardia substrate ablation site may be in a location that is difficult to reach with the curve on a standard guiding sheath and/or ablation catheter. A sheath with a more acute curve may be desirable. Performing a transseptal procedure initially with such a curve may be inadvisable, however, due to the tendency for such a sheath to redirect the transseptal needle away from the desired septal puncture site and increase the risk of the procedure. However, removal of the standard guiding sheath for replacement with a different curved sheath can result in loss of left atrial transseptal position. This could require a repeat transseptal puncture, which presents a challenge in a heparinized patient. Accordingly, a need exists for an improved transseptal left heart catheterization method.
SUMMARY OF THE INVENTION
The present invention provides a unique system and method particularly useful for performing left heart catheterization using the transseptal approach.
In one embodiment, the invention is directed to an exchange dilator for use with a guiding sheath for introduction into the heart. The exchange dilator comprises a flexible tubing having a generally constant diameter along its length, two tapered ends and a lumen therethrough. The exchange dilator permits a physician to replace a first guiding sheath having a given curve with a second guiding sheath having a different desired curve while the distal end of the dilator is maintained within the heart. Accordingly, the physician can maintain the left atrial transseptal position when exchanging the guiding sheaths.
In another embodiment, the invention is directed to a guiding sheath exchange system comprising an exchange dilator as described above and a guidewire capable of fitting within the lumen of the exchange dilator and having a length greater than the length of the exchange dilator. When the system is used in connection with a guiding sheath that has a valve at its proximal end for hemostatis, the system preferably further comprises a guidewire funnel. The guidewire funnel comprises a generally tubular body having a tapered distal end and a lumen therethrough. The guidewire funnel is inserted into the proximal end of the guiding sheath into the valve to facilitate introduction of the guidewire into the distal end of the valve. The funnel has a length ranging from about 1 inch to about 5 inches.
In yet another embodiment, the invention is directed to a guiding sheath exchange system comprising first and second guiding sheaths and an exchange dilator as described above. Each guiding sheath has proximal and distal ends and at least one lumen extending therethrough. The first guiding sheath has a first predefined curve at its distal end and the second guiding sheath has a second predefined curve at its distal end different from the first predefined curve. The dual-tapered exchange dilator facilitates replacement of the first guiding sheath with the second guiding sheath.
In still another embodiment, the invention is directed to a method for replacing a first guiding sheath with a second guiding sheath. In accordance with the method, the distal end of an exchange dilator, as described above, is inserted into the proximal end of the lumen of the first guiding sheath. The distal end of the exchange dilator is fed through the lumen so that it extends distal the distal end of the first guiding sheath. The first guiding sheath is removed from the patient's body while the distal end of the exchange dilator is left in the body. The proximal end of the exchange dilator is inserted into the distal end of the lumen of the second guiding sheath. The distal end of the second guiding sheath is introduced into the body over the dilator so that the distal end of the second guiding sheath is in the heart.
In even another embodiment, the invention is directed to a method for replacing a first guiding sheath with a second guiding sheath. The method comprises introducing the distal end of an exchange dilator, as described above, and the distal end of a guidewire into the proximal end of the lumen of the first guiding sheath. The distal end of the exchange dilator and the distal end of the guiding sheath are fed through the lumen so that they extend distal the distal end of the first guiding sheath. The first guiding sheath is removed from the patient's body while the exchange dilator and guidewire are left in the body. The proximal end of the guidewire is introduced into the distal end of the lumen of the second guiding sheath. The second guiding sheath is introduced over the exchange dilator so that the distal end of the second guiding sheath is in the heart. In a particularly preferred embodiment of this method, the second guiding sheath has a valve near its proximal end. The method further comprises providing a guidewire funnel, as described above, and inserting the tapered distal end of the guidewire funnel into the proximal end of the second guiding sheath so that the distal end passes through the valve. The proximal end of the guidewire is introduced into the distal end of the lumen of the second guiding sheath and into the distal end of the lumen of the guidewire funnel.
In another embodiment, the invention is directed to a method for performing transseptal left heart catheterization in a patient's heart. A first guiding sheath is provided having proximal and distal ends and a lumen therethrough, and a first dilator is provided having proximal and distal ends and a lumen therethrough. The first dilator is assembled into the lumen of the first guiding sheath so that the distal end of the dilator protrudes beyond the distal end of the first guiding sheath. A first guidewire having proximal and distal ends is introduced into the patient's body so that the distal end of the guidewire is in the right atrium of the patient's heart. The assembled guiding sheath and dilator are passed over the first guidewire into the right atrium. A needle having proximal and distal ends is introduced into the lumen of the dilator and advanced therethrough until the distal end of the needle is in the right atrium. The needle is pushed through the septum to create a hole in the septum. The distal end of the first guiding sheath is advanced through the hole and into the left atrium. The needle, dilator and guidewire are withdrawn from the patient's body. An exchange dilator, as described above, is provided. A second guidewire is introduced into the lumen of the exchange dilator. The distal ends of the second guidewire and exchange dilator are advanced into the proximal en
Fuimaono Kristine B.
Perry James C.
Pham Mimi L.
van Erp Wilko
Christie Parker & Hale LLP
O'Connor Cary
Wingood Pamela
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