Retaining apparatus and procedure for transseptal catheterization
First Claim
1. A cardiac transseptal sheath for a transseptal catheterization procedure which involves positioning the sheath across a septum between a right atrium and a left atrium of a heart, said sheath having a main lumen and having selectively deployable retaining means for retaining a distal tip of said sheath in relation to the septum during the catheterization procedure, said sheath having a curved distal end to facilitate emplacement in the left atrium and passage therethrough of devices for diagnostic or therapeutic purposes.
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Accused Products
Abstract
The invention comprises retaining apparatus for transseptal catheterization and a procedure for the use of same. The retaining apparatus is a selectively deployable retaining means disposed at or proximal to the tip of a transseptal catheter or sheath which is placed across a septum, such as the interatrial septum, into the left atrium. The retaining means is configured to cooperate with the distal portion of the sheath to present a uniform cylindrical circumferential periphery when the retaining means is undeployed and to present a shape generally transverse to the longitudinal axis of the sheath when deployed. In a preferred embodiment, the retaining means is a retaining balloon which, upon inflation, presents a relatively flat, disk-like shape to comprise a physical barrier preventing inadvertent retraction of the distal tip of the sheath from the left atrium during subsequent portions of the catheterization procedure. The transseptal catheterization procedure includes the steps of placing the distal tip of the transseptal sheath across a septum, deploying the retaining means for retaining the distal tip within the left atrium, completing the transseptal portion of the catheterization procedure, retracting the selectively deployable retaining means, withdrawing the distal tip from the septum and completing the procedure.
458 Citations
24 Claims
- 1. A cardiac transseptal sheath for a transseptal catheterization procedure which involves positioning the sheath across a septum between a right atrium and a left atrium of a heart, said sheath having a main lumen and having selectively deployable retaining means for retaining a distal tip of said sheath in relation to the septum during the catheterization procedure, said sheath having a curved distal end to facilitate emplacement in the left atrium and passage therethrough of devices for diagnostic or therapeutic purposes.
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19. A procedure for cardiac transseptal catheterization comprising the steps of:
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a) placing a curved distal tip of a transseptal sheath across the interatrial septum; b) deploying retaining means for retaining said distal tip in relation to the septum, whereby deployment of said retaining means secures said distal tip in relation to the septum during subsequent portions of the procedure; c) comprising a transseptal portion of the catheterization procedure; d) retracting said retaining means; and e) withdrawing said distal tip from the septum and completing the catheterization procedure. - View Dependent Claims (20, 21, 22)
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23. A procedure for cardiac transseptal catheterization comprising the steps of:
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a) percutaneously puncturing a vein with a hollow needle; b) placing a spring guidewire within the needle into the vein; c) removing said needle; d) introducing a curved sheath with inner dilator over said guidewire; e) advancing said sheath and dilator into the vein and into the superior vena cava; f) removing said guidewire; g) advancing a stylet and said transseptal needle through said dilator and sheath; h) withdrawing said stylet from said transseptal needle; i) drawing back said transseptal needle, said dilator and said sheath until said transseptal needle, dilator and sheath enter the right atrium; j) placing the tip of a combination of said sheath, dilator and transseptal needle against a desired location of the interatrial septum; k) puncturing said interatrial septum with said transseptal needle; l) advancing the tip of the dilator and sheath through the septum and into the left atrium; m) withdrawing said transseptal needle and dilator; n) deploying a soft, compliant retaining means for retaining the sheath tip within the left atrium; o) drawing back said sheath until said retaining means bears against the septum; p) continuing with the remaining left heart portion of the catheterization procedure; q) retracting said retaining means; r) withdrawing said sheath tip from the left atrium; and s) completing the remaining portion of said catheterization procedure.
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24. A procedure for cardiac transseptal catheter comprising the steps of:
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a) percutaneously puncturing a femoral vein with a hollow needle; b) placing a spring guidewire within the needle into the femoral vein; c) removing said needle; d) introducing a curved sheath with inner dilator over said guidewire; e) advancing said sheath and dilator into the femoral vein and advancing said sheath and dilator to the superior vena cava; f) removing said guidewire; g) advancing a stylet and said transseptal needle through said dilator and sheath; h) withdrawing said stylet from said transseptal needle; i) drawing back said transseptal needle, said dilator and said sheath until said transseptal needle, dilator and sheath enter the right j) placing the tip of said sheath-dilator-transseptal needle combination against a desired location of the interatrial septum; k) puncturing said interatrial septum with said transseptal needle; l) confirming the presence of the transseptal needle in the left atrium; m) advancing the tip of the dilator and sheath through the septum and into the left atrium; n) withdrawing said transseptal needle and dilator; o) deploying a soft, compliant retaining means for retaining the sheath tip within the left atrium; p) drawing back said sheath until said retaining means bears against the septum; q) continuing with the remaining left heart portion of the catheterization procedure; r) retracting said retaining means; s) withdrawing said sheath tip from the left atrium; and t) completing the remaining portion of said catheterization procedure.
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Specification