Occluding anatomical structures
An elongate resilient tube of a mesh of shape memory alloy is used to therapeutically occlude an opening in body tissue. The tube is compressible so that it can be delivered to the opening in the body within a catheter. The tube self-expands as it is released from the catheter to contiguously form, sequentially an outer perimeter structure and an inner perimeter structure disposed within the outer perimeter structure to conformingly engage an inner side of the outer perimeter structure, a plate shaped structure, and a flexible connector between them. J-shaped hooks extend from the perimeter structure to flexibly engage tissue of the body opening without piercing the tissue.
1. A device for occluding an appendage inside a living body forming an elongate passage and having an open entrance and a hollow interior, comprising:
at least one elongate resilient tube formed of a mesh of shape memory alloy, the at least one tube compressible to be delivered to the appendage within a catheter, the at least one tube self-expanding as the at least one tube is released from the catheter to contiguously form, sequentially:
an outer perimeter structure
that is elongate on a side portion of the outer perimeter structure to be sized and dimensioned to flexibly conform to a longitudinal anatomy of an interior surface of the appendage extending along a longitudinal axis of the appendage when the device is deployed within the appendage;
an inner perimeter structure
sized and dimensioned along an elongate contact area to flexibly and conformingly contact and abut an interior of the outer perimeter structure along the longitudinal anatomy to thereby mutually conform to interior surface of the appendage together with the outer perimeter structure when the device is deployed within the appendage,
the inner perimeter structure thereby frictionally engaging the outer perimeter structure along the elongate contact area to thereby resist displacement of the outer perimeter structure along the longitudinal axis of the appendage, the inner perimeter structure and the outer perimeter structure thereby together forming a single double-walled perimeter structure defining a hollow interior;
a double-walled plate-shaped structure connected to the double-walled structure to be positioned outside of the hollow interior and formed contiguously from the material of the double-walled perimeter, the plate-shaped structure sized and dimensioned to completely occlude the entrance to the appendage while the double-walled perimeter is positioned inside the appendage; and
a plurality of hooks each
affixed to the outer perimeter structure
to extend away from the outer perimeter structure,
forming a barb having a J-shape, and
forming a sharp free end profile at an end of the barb.
2. The device of claim 1 , the plurality of hooks defining rows encircling a perimeter of the device.
3. The device of claim 1 , hooks of the plurality of hooks having a height of 1.0 mm+/−0.25 mm as measured from a curved end of the J-shape to the sharp free end profile.
4. The device of claim 1 , hooks of the plurality of hooks having a length of 1.5 mm+/−0.25 mm as measured from a surface of the outer perimeter structure from which the barb extends to the sharp free end profile of the barb.
5. The device of claim 1 , wherein hooks of the plurality of hooks can be pulled straight when the at least one tube is returned to the catheter, and the hook will re-form the J-shape after the at least one tube is again released from the catheter.
6. The device of claim 1 , wherein at least two hooks of the plurality of hooks are formed from a single wire bent to form a U-shape before the wire is affixed to the outer perimeter structure.
7. The device of claim 6 , wherein a curved portion of the U-shape is folded upon itself when the single wire is affixed to the outer perimeter structure.
8. The device of claim 1 , wherein the at least one elongate resilient tube includes first and second elongate resilient tubes, the second elongate resilient tube disposed within the first elongate resilient tube.
9. A method for occluding an appendage inside a living body, comprising delivering by a catheter the device of claim 1 , and positioning the device in the appendage to engage the plurality of hooks with body tissue.
10. The method of claim 9 , wherein each of the plurality of hooks are sized to pierce the body tissue without passing through an external wall of the appendage.
11. The method of claim 10 , wherein the appendage is the left atrial appendage (LAA).
12. The method of claim 9 , wherein the at least one elongate resilient tube is a single elongate resilient tube, which is partially involuted to form inner and outer sleeves that form the single double-walled perimeter structure.
13. The device of claim 1 , further including a tubular connector having a diameter substantially smaller than the double-walled perimeter structure and the opening of the appendage, the tubular connector extending away from an apex of the double-walled perimeter structure and through the hollow perimeter interior to thereby join the double-walled perimeter structure to the plate-shaped structure.
14. A device for occluding an appendage inside a living body forming an elongate passage and having an open entrance and a hollow interior, comprising:
at least one elongate resilient tube formed of a mesh of shape memory alloy, the at least one tube compressible to be delivered to the appendage within a catheter, the at least one tube self-expanding as the at least one tube is released from the catheter to contiguously form, sequentially:
an outer bell-shaped structure
that is elongate on a side portion of the bell-shape, the side portion having an external contacting surface sized and dimensioned to flexibly conform to and contact a longitudinal anatomy of an interior surface of the appendage extending along a longitudinal axis of the appendage when the device is deployed within the appendage;
an inner bell-shaped structure
sized and dimensioned along an elongate contact area to flexibly and conformingly abut an interior of the outer bell-shaped structure along the longitudinal axis of the appendage against an opposing surface of the external contacting surface of the outer bell-shaped structure side portion to thereby mutually conform to the interior surface of the appendage together with the outer bell-shaped structure when the device is deployed within the appendage,
the inner bell-shaped structure frictionally engaging the outer bell-shaped structure along the elongate contact area to thereby resist displacement of the outer bell-shaped structure along the longitudinal axis of the appendage, the inner bell-shaped structure and the outer bell-shaped structure thereby together forming a single double-walled bell-shaped structure defining a hollow bell interior;
and
a plurality of hooks each
affixed to the outer bell-shaped structure
to extend away from the outer bell-shaped structure,
forming a barb having J-shape, and
forming a sharp free end profile at an end of the barb,
having a height extending from the external contacting surface not greater than a depth of the tissue of the longitudinal anatomy of an interior surface of the appendage.
15. The device of claim 14 , the plurality of hooks defining rows encircling a perimeter of the device.
16. The device of claim 14 , hooks of the plurality of hooks having a height of 1.0 mm+/−0.25 mm as measured from a curved end of the J-shape to the sharp free end profile.
17. The device of claim 14 , hooks of the plurality of hooks having a length of 1.5 mm+/−0.25 mm as measured from a surface of the outer perimeter structure from which the barb extends to the sharp free end profile of the barb.
18. The device of claim 14 , wherein hooks of the plurality of hooks can be pulled straight when the at least one tube is returned to the catheter, and the hook will re-form the J-shape after the at least one tube is again released from the catheter.
19. The device of claim 14 , wherein at least two hooks of the plurality of hooks are formed from a single wire bent to form a U-shape before the wire is affixed to the outer bell-shaped structure.
20. The device of claim 14 , wherein a curved portion of the U-shape is folded upon itself when the single wire is affixed to the outer bell-shaped structure.