Heart occlusion devices

Abstract

This disclosure is directed to an aperture occlusion device and a method for occluding an aperture, including a perimembranous ventricular septal defect. The aperture occlusion device includes a wire frame element. The wire frame forms geometric shapes that include an occluder region and a securing region. The occluder region and the securing region are separated by an attachment region including a waist. The occluder region and securing region can include membranous coverings. The device can be attached to a delivery hub. The wires forming the occluder region and securing region can have a shape-memory capability such that they can be collapsed and distorted in a sheath during delivery, but resume and maintain their intended shape after delivery.

We claim: 
     
         1 . A single-disc device for occluding an aperture within a body of a patient, comprising:
 an occluder region comprising a frame element, the frame element comprising a plurality of wire portions, the plurality of wire portions configured to form a disc at a first end of the single-disc device, wherein the disc generally defines a disc plane;   an attachment region with an axis that extends transversely to the disc plane, the attachment region comprising an occluder region attachment end and a securing region attachment end, the occluder region attachment end being connected to the occluder region; and   a securing region connected to the securing region attachment end and at a second end of the single-disc device, the securing region comprising one or more securing members, wherein a major axis of each of the one or more securing members extends transversely to the axis of the attachment region and all major axes of the one or more securing members are generally located within a circular sector having an arc of about 180 degrees or less.   
     
     
         2 . The single-disc device of  claim 1 , wherein the major axes of the securing members are spaced symmetrically within the circular sector having an arc of about 180 degrees or less. 
     
     
         3 . The single-disc device of  claim 1 , wherein the one or more securing members each comprise one or more wire loops or wire prongs. 
     
     
         4 . The single-disc device of  claim 1 , wherein the circular sector has an arc of 150 degrees or less. 
     
     
         5 . The single-disc device of  claim 1 , wherein the major axis of each of the one or more securing members extends at an angle between 80 and 100 degrees with respect to the axis of the attachment region. 
     
     
         6 . The single-disc device of  claim 1 , wherein the securing region comprises three or more securing members. 
     
     
         7 . The single-disc device of  claim 1 , wherein the disc plane extends at an angle between 0 to 5 degrees with respect to the major axis of at least one of the one or more securing members. 
     
     
         8 . The single-disc device of  claim 1 , wherein the disc plane extends at an angle between 5 to 15 degrees with respect to the major axis of at least one of the one or more securing members. 
     
     
         9 . The single-disc device of  claim 1 , wherein the occluder region comprises a membrane configured to inhibit passage of blood, wherein the membrane covers at least a portion of the disc. 
     
     
         10 . The single-disc device of  claim 9 , wherein the membrane comprises a fluoropolymer. 
     
     
         11 . The single-disc device of  claim 9 , wherein the membrane comprises polytetrafluoroethylene. 
     
     
         12 . The single-disc device of  claim 9 , wherein the membrane comprises expanded polytetrafluoroethylene. 
     
     
         13 . The single-disc device of  claim 1 , wherein the occluder region further comprises an expandable balloon configured to restrict fluid flow through the aperture. 
     
     
         14 . The single-disc device of  claim 1 , wherein the occluder region comprises at least one anchor. 
     
     
         15 . The single-disc device of  claim 1 , comprising one or more visual indicators configured to identify the orientation of the securing region. 
     
     
         16 . The single-disc device of  claim 1 , wherein the disc plane extends at an angle between 75 to 105 degrees with respect to the axis of the attachment region. 
     
     
         17 . The single-disc device of  claim 1 , wherein the first end is at the proximal end of the single-disc device and the second end is at the distal end of the single-disc device. 
     
     
         18 . A method of occluding a cardiac defect, comprising:
 providing a single-disc device comprising:
 an occluder region comprising a frame element, the frame element comprising a plurality of wire portions, the plurality of wire portions configured to form a disc at a first end of the single-disc device, wherein the disc generally defines a disc plane; 
 an attachment region with an axis that extends transversely to the disc plane, the attachment region comprising an occluder region attachment end and a securing region attachment end, the occluder region attachment end being connected to the occluder region; and 
 a securing region connected to the securing region attachment end and at a second end of the single-disc device, the securing region comprising one or more securing members, wherein a major axis of each of the one or more securing members extends transversely to the axis of the attachment region and all major axes of the one or more securing members are generally located within a circular sector having an arc of 180 degrees or less; 
   configuring the single-disc device in a delivery configuration and advancing the single-disc device to a delivery site; and   deploying the single-disc device at the delivery site.   
     
     
         19 . The method according to  claim 18 , comprising coupling the single-disc device to a delivery catheter. 
     
     
         20 . The method according to  claim 19 , comprising inserting the single-disc device and the delivery catheter into a delivery sheath. 
     
     
         21 . The method according to  claim 20 , wherein the frame element collapses as the single-disc device is inserted into the delivery sheath. 
     
     
         22 . The method according to  claim 20 , wherein deploying the single-disc device comprises advancing the single-disc device through the delivery sheath, such that at least a portion of the single-disc device exits the delivery sheath distal of the delivery sheath. 
     
     
         23 . The method according to  claim 22 , wherein the frame element expands as the single-disc device exits the delivery sheath. 
     
     
         24 . The method according to  claim 20 , wherein deploying the single-disc device comprises pulling the delivery sheath away from the cardiac defect while maintaining a position of the single-disc device. 
     
     
         25 . The method according to  claim 18 , wherein deploying the single-disc device substantially occludes the cardiac defect. 
     
     
         26 . A system for occluding an aperture within a body of a patient, comprising:
 a single-disc occluder device comprising:
 an occluder region comprising a frame element, the frame element comprising a plurality of wire portions, the plurality of wire portions configured to form a disc at a first end of the single-disc device, wherein the disc generally defines a disc plane; 
 an attachment region with an axis that extends transversely to the disc plane, the attachment region comprising an occluder region attachment end and a securing region attachment end, the occluder region attachment end being connected to the occluder region; and 
 a securing region connected to the securing region attachment end and at a second end of the single-disc device, the securing region comprising one or more securing members, wherein a major axis of each of the one or more securing members extends transversely to the axis of the attachment region and all major axes of the one or more securing members are generally located within a circular sector having an arc of 180 degrees or less; 
   a deployment wire releasably attached to the first end of the single-disc device;   a delivery catheter comprising a sheath configured to contain the deployment wire and the single-disc occluder device arranged in a delivery configuration, the delivery catheter configured to advance the single-disc device to a delivery site; and   an actuator device attached to a proximal end of the delivery catheter, the actuator device being configured to remotely control deployment of the single-disc device at the delivery site.   
     
     
         27 . A method of occluding a blood vessel, comprising:
 providing a single-disc device comprising:
 an occluder region comprising a frame element, the frame element comprising a plurality of wire portions, the plurality of wire portions configured to form a disc at a first end of the single-disc device, wherein the disc generally defines a disc plane; 
 an attachment region with an axis that extends transversely to the disc plane, the attachment region comprising an occluder region attachment end and a securing region attachment end, the occluder region attachment end being connected to the occluder region; and 
 a securing region connected to the securing region attachment end and at a second end of the single-disc device, the securing region comprising one or more securing members, wherein a major axis of each of the one or more securing members extends transversely to the axis of the attachment region and all major axes of the one or more securing members are generally located within a circular sector having an arc of 180 degrees or less; 
   configuring the single-disc device in a delivery configuration and advancing the single-disc device to a delivery site in the vessel; and   deploying the single-disc device at the delivery site in the vessel.   
     
     
         28 . The method according to  claim 27 , comprising:
 coupling the single-disc device to a delivery catheter;   inserting the single-disc device and the delivery catheter into a delivery sheath, wherein the frame element collapses as the single-disc device is inserted into the delivery sheath, and wherein the frame element expands as the single-disc device exits the delivery sheath.   
     
     
         29 . The method according to  claim 28 , wherein deploying the single-disc device comprises advancing the single-disc device through the delivery sheath, such that at least a portion of the single-disc device exits the delivery sheath distal of the delivery sheath.