Method and apparatus for arteriotomy closure
OwnerGene Myers, William S. Couryinventors
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Abstract
The present invention provides an apparatus and a method for quickly and effectively sealing an arteriotomy site in a patient. In particular, the invention provides an apparatus and a method for sealing an arteriotomy site which can be performed by a single operator. The arteriotomy can be sealed by delivery of a suitable sealant such as a patient specific autologous fibrin glue to a debrided, synthesized area adjacent to the extravascular opening of the arteriotomy. Alternatively, synthetically produced fibrin glue or other sealants can be utilized in a method of sealing an arteriotomy site.
Claims47
An apparatus for sealing an arteriotomy site comprising:
- a. a first elongated flexible catheter having a proximal end, a distal end, an external surface, and a wall portion defining at least one lumen extending substantially the entire length of said first catheter, and at least one opening through the external surface of said first catheter located adjacent the distal end, such that the proximal end of the lumen is in fluid communication with the external surface of said first catheter via said opening;
- b. a means located adjacent the distal end of said first catheter for temporarily occluding the intravascular opening of the arteriotomy site when said occluding means is positioned in the intravascular space of the patient's artery proximate to the arteriotomy site;
- c. a means for delivering a material to the arteriotomy site that is capable of forming a substantially fluid tight seal of the arteriotomy site;
- and
- d. a means for debriding subcutaneous tissue from the exterior surface of the anterior arterial wall proximate to the arteriotomy site comprised of an extravascular expandable member on the external surface of said first catheter adjacent the distal end thereof and located at a first predetermined distance therefrom, wherein said extravascular expandable member is a second balloon surrounding a portion of the external surface of said first catheter and having a closed volume, said second balloon overlying a second opening in the external surface of said first catheter wherein the closed volume of said second balloon is in fluid communication with a second lumen of said catheter such that said second balloon may be inflated or deflated by a fluid added or removed respectively through the second lumen of said first catheter.
An apparatus for sealing an arteriotomy site comprising:
- a. a first elongated flexible catheter having a proximal end, a distal end, an external surface, and a wall portion defining at least one lumen extending substantially the entire length of said first catheter, and at least one opening through the external surface of said first catheter located adjacent the distal end, such that the proximal end of the lumen is in fluid communication with the external surface of said first catheter via said opening;
- b. a means located adjacent the distal end of said first catheter for temporarily occluding the intravascular opening of the arteriotomy site when said occluding means is positioned in the intravascular space of the patient's artery proximate to the arteriotomy site;
- c. a means for delivering a material to the arteriotomy site that is capable of forming a substantially fluid tight seal of the arteriotomy site;
- and
- d. a means for debriding subcutaneous tissue from the exterior surface of the anterior arterial wall proximate to the arteriotomy site, wherein said debriding means comprises an extravascular expandable member positioned on a second elongated flexible catheter having a front end, a rear end, an outer surface, and a body portion, and wherein said debriding means is located adjacent the rear end, said second catheter comprising:
- i. a central bore defined by the body portion extending through the length of said second catheter communicating the front end with the rear end;
- and
- ii. a means for expanding said extravascular expandable member.
A method of sealing an arteriotomy site in a patient against the internal to external pressure gradient produced by the patient's cardiovascular system, comprising the steps of:
- a. placing into proper position within the arteriotomy site an apparatus having a means for temporarily occluding the intravascular opening of the arteriotomy site when said occluding means is positioned in the intravascular space of the patient's artery proximate to the arteriotomy site and having a means for delivering a material to the arteriotomy site that is capable of forming a substantially fluid tight seal of the arteriotomy site;
- b. occluding temporarily the intravascular opening of the arteriotomy site with said occluding means;
- c. debriding subcutaneous tissue from the exterior surface of the anterior arterial wall proximate to the arteriotomy site;
- d. delivering a material to the arteriotomy site via said delivery means which is capable of forming a substantially fluid tight seal of the arteriotomy site;
- and
- e. withdrawing said apparatus from the arteriotomy site.
Dependencies are inferred from the claim text.