Monofilament implants and systems for delivery thereof
US-2024350249-A1 · Oct 24, 2024 · US
US2016174979A1 · US · A1
| Field | Value |
|---|---|
| Publication number | US-2016174979-A1 |
| Application number | US-201414577852-A |
| Country | US |
| Kind code | A1 |
| Filing date | Dec 19, 2014 |
| Priority date | Dec 19, 2014 |
| Publication date | Jun 23, 2016 |
| Grant date | — |
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Official abstract text for this publication.
The invention provides improved devices, systems, and methods for tissue approximation and repair at treatment sites. The invention provides devices, systems, and methods that may more successfully approximate and repair tissue by improving the capture of tissue into the devices. The invention may be a one-way mechanism that allows tissue to enter the mechanism but not easily exit, such as a leaf-spring, a protrusion, a pivoting arm and one or more frictional elements.
Opening claim text (preview).
What is claimed is: 1 . A fixation device for engaging tissue comprising: a pair of distal elements each having a first end, a free end opposite the first end, and an engagement surface therebetween; a pair of proximal elements each having a first end, a free end opposite the first end, and an engagement surface therebetween; and a shaft to which the first ends of the proximal elements and distal fixation elements are operably coupled; where each of the distal elements comprises a retaining element located on its engagement surface that is designed to permit tissue to move toward the first end of the distal element and to resist movement of the tissue away from the first end of the distal element, the retaining element extending along substantially an entire length of the distal element from a proximal end towards a junction of a distal end with the shaft. 2 . The fixation device of claim 1 , wherein each proximal element further comprises one or more frictional elements on the engagement surface. 3 . The fixation device of claim 2 , wherein the frictional elements located on each proximal element comprise one or more barbs that are oriented at an angle pointing toward the shaft. 4 . The fixation device of claim 1 , wherein each retaining element further comprises one or more frictional elements. 5 . The fixation device of claim 4 , wherein the frictional elements located on each of the retaining elements comprises at least one leaf spring configured to direct or urge the tissue toward engagement with the barbs located on one of the proximal elements. 6 . The fixation device of claim 4 , wherein the frictional elements located on each of the retaining elements comprises at least one protrusion configured to direct or urge the tissue toward engagement with the barbs located on one of the proximal elements. 7 . The fixation device of claim 4 , wherein the frictional elements located on each of the retaining elements comprises at least one hinged or pivoting arm configured to direct or urge the tissue toward engagement with the barbs located on one of the proximal elements. 8 . A fixation device intended for intravascular delivery and for use in treating mitral valve defects, the device comprising: a pair of proximal elements each having a proximal engagement surface between a first end coupled to a body and a free second end; a pair of distal elements each having a distal engagement surface between a first end pivotally coupled to the body and a free second end; and a first one of the proximal elements cooperating with a first one of the distal elements to form a space for receiving a portion of tissue therebetween, and a second one of the proximal elements cooperating with a second one of the distal elements to form a space for receiving a portion of the tissue therebetween; wherein each distal element further comprises a retaining element extending in an elongate fashion from a proximal portion of the distal engagement surface to a location distal a midpoint of the distal engagement surface, the retaining element having a fixed proximal end mounted to the distal engagement surface and a free distal end spaced apart from the distal engagement surface, each retaining element being configured to cooperate with a corresponding frictional element on each proximal element to capture a free edge of the tissue. 9 . The device of claim 8 , wherein the retaining element includes a tissue engaging curved portion disposed along a length thereof, the tissue engaging curved portion transitioning the retaining element from extending away from the distal engagement surface to extending towards the distal engagement surface. 10 . The device of claim 9 , wherein the tissue engaging curved portion cooperates with the proximal element to guide tissue disposed therebetween. 11 . The device of claim 8 , wherein the retaining element extends along substantially an entire length of the distal engagement surface from the proximal end to a junction of the distal element with an actuator configured to deploy the distal element. 12 . The device of claim 8 , wherein the retaining element is biased toward the distal element and lay flat against the distal engagement surface. 13 . The device of claim 8 , wherein the retaining element is biased away from the distal element. 14 . The device of claim 8 , wherein the retaining elements is configured to curve toward the distal element when the tissue is trapped between the proximal element and the distal element and is configured to curve away from the distal element when the tissue is released. 15 . The device of claim 8 , wherein the retaining element is configured to urge the tissue against engagement features of the proximal element. 16 . The device of claim 8 , wherein the retaining element is configured to rotate up to 180 degrees, the free second end being movable from the distal end of the distal element towards the proximal end of the distal element. 17 . The device of claim 15 , wherein the retaining element is configured to lay flat against a proximal portion of the distal engagement surface. 18 . A device intended for intravascular delivery and for use in treating mitral valve defects in human patients, the device comprising: a body; a pair of proximal elements, each being coupled at a first end to the body on opposite sides of the body, each having a free second end, and each having a proximal engagement surface between the first and second ends thereof, and; a pair of distal elements, each being pivotally coupled at a first end to the body on opposite sides of the body, each having a free second end, and each having a distal engagement surface between the first and second ends thereof; a first one of the proximal elements cooperating with a first one of the distal elements to form a space for receiving a portion of tissue therebetween, and a second one of the proximal elements cooperating with a second one of the distal elements to form a space for receiving a portion of the tissue therebetween, each said space having an open end and a closed end, the closed end forming an apex; and wherein each distal element further comprises a retaining element positioned along the distal engagement surface and extending from a proximal end of the distal engagement surface to a location adjacent a distal end of the distal engagement surface, each retaining element configured to cooperate with a corresponding frictional element to capture a free edge of the tissue as the device is positioned relative to the mitral valve. 19 . The device of claim 18 , wherein each proximal engagement surface also has a frictional element configured to permit tissue to move toward the first end of the proximal element and to resist movement of the tissue away from the first end of the proximal element. 20 . The device of claim 18 , further comprising an actuator for selectively moving the distal elements between a first position in which the distal elements are in a collapsed, low profile configuration for delivery of the device, a second position in which the distal elements are in an expanded configuration for positioning the device relative to the tissue, and a third position in which the distal elements are secured in position against a portion of the tissue, and for selectively moving the proximal elements between a first position in which the proximal elements are in a collapsed, low profile configuration for delivery of the device and a second position in which the proximal e
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