Devices, systems, and methods for occluding cavities within the body
Disclosed are embodiments of a device for closing or occluding a cavity or opening within a body. Some embodiments of the device can include an implant configured to be deployed within the cavity, configured to be expanded or moved against a wall portion of the cavity, and configured to twist at least a portion of the cavity when the implant is rotated. Thereafter, a securing element, staple, suture, or other fastener can be implanted in the gathered tissue to hold the tissue in the gathered state, thereby occluding the opening of the cavity. The implant can remain in the cavity or be removed.
1. A device for reshaping, closing, or occluding a cavity, comprising:
an implant comprising:
a contact member configured to move between a first state and a second state, the contact member including one or more anchor features, the contact member being positioned along a longitudinal axis;
a retaining member; and
a securing element coupled with the contact member via the retaining member;
wherein:
the contact member is configured to engage a wall portion of the cavity after the contact member has been advanced into the cavity;
the contact member is configured to rotate at least in a first angular direction from a first position to a second position;
the contact member is configured to twist at least a portion of the wall portion of the cavity in the first angular direction when the contact member is engaged with the wall portion of the cavity and is rotated from the first position to the second position to twist tissue of the wall portion of the cavity through engagement between the one or more anchor features and the tissue and thereby draw at least a first portion of the wall portion of the cavity toward a second portion of the wall portion of the cavity; and
the securing element is configured to prevent a rotation of the wall portion of the cavity in a second angular direction when the securing element is implanted in an operable state, to thereby maintain the tissue in a twisted state, wherein the second angular direction is opposite to the first angular direction about the longitudinal axis.
2. The device of claim 1 , wherein the contact member is self-expandable such that at least a portion of the contact member automatically expands from the first state to the second state when a restraint is removed from the contact member.
3. The device of claim 1 , wherein the contact member is biased to remain in the second state after deployment into the cavity.
4. The device of claim 1 , wherein the contact member is configured to be removable from the cavity after the securing element is implanted.
5. The device of claim 1 , wherein the contact member is configured to be rotated in a clockwise or in a counter-clockwise direction, or configured to be rotated in a clockwise or in a counter-clockwise direction after the contact member has engaged with a wall portion of the cavity.
6. The device of claim 1 , wherein the device is configured to cause a tissue of the cavity to constrict around an outer surface of a body portion of the device when the contact member is rotated to the second position, and the securing element configured to engage with the tissue of the cavity that has constricted around the outer surface of the body portion of the device or a tissue adjacent to the cavity to prevent rotation of the contact member and/or the tissue in the second angular direction.
7. The device of claim 6 , wherein the securing element has a plurality of tissue anchors configured to engage with a portion of a tissue of the cavity that has constricted around the outer surface of the body portion of the device or a tissue adjacent to the cavity to prevent rotation of the contact member and/or the tissue in the second angular direction.
8. The device of claim 7 , wherein the plurality of tissue anchors on the outside surface of the contact member are configured to engage an inner wall surface of the cavity after the contact member has been moved to the second state.
9. The device of claim 1 , wherein the securing element has a helical shape and is configured to rotate about a body portion of the implant during implantation.
10. The device of claim 1 , wherein the second position is from approximately one-quarter of a complete rotation to one or more complete rotations relative to the first position.
11. The device of claim 1 , the retaining member being configured to bias the securing element toward the contact member.
12. The device of claim 1 , wherein the retaining member comprises a threaded shaft.
13. The device of claim 1 , wherein the contact member is configured to rotate at least in the first angular direction from the first position to the second position when a torque is applied to the contact member.
14. The device of claim 1 , wherein the securing element is structurally configured such that only a portion of the securing element extends out of the cavity after deployment of the device, and all other portions of the device are internal to the cavity after deployment of the device.
15. The device of claim 1 , wherein the device is structurally configured such that only approximately 10% or less of an overall length of the device extends out of the cavity after deployment of the device.
16. The device of claim 1 , wherein at least a portion of the contact member is inflatable and deflatable.
17. The device of claim 1 , wherein the contact member comprises a balloon.
18. The device of claim 1 , wherein the securing element is removably coupleable with the contact member.
19. The device of claim 1 , wherein the device is configured and operable to reshape, close, or occlude a cavity that comprises a wound or a wound cavity.
20. The device of claim 1 , further comprising a catheter configured to advance the contact member into the cavity when the contact member is in the first state and to cause the contact member to move from the first state to the second state so that an outside surface of the contact member expands against an inner wall surface of the cavity after the contact member has been advanced into the cavity, wherein the catheter is configured to exert a torque on the contact member when at least a portion of the catheter is rotated until a predetermine torque level is reached to rotate the contact member from the first position to the second position so that the contact member twists at least a portion of the cavity.
21. A method of reshaping, closing, or occluding a cavity, comprising:
advancing a deployment device having the device for reshaping, closing, or occluding a cavity of claim 1 into the cavity;
moving the implant of the device for reshaping, closing, or occluding a cavity so as to move at least a portion of an outside surface of the implant or one or more tissue anchors extending away from an outer surface of the implant against an inner wall surface of the cavity;
rotating the contact member of the implant from a first position to a second position to twist the cavity; and
preventing the contact member from rotating back to the first position.
22. The method of claim 21 , wherein the contact member is self-expanding and wherein moving the contact member from the first state to the second state comprises advancing the contact member out of a distal end of the deployment device.
23. The method of claim 21 , comprising engaging a wall portion on an inside of the cavity with one or more tissue anchors positioned on an outside surface of the contact member.
24. The method of claim 21 , wherein preventing the contact member from rotating back to the first position comprises engaging a tissue wall with an anchor element to prevent relative movement between the contact member and the tissue wall.
25. The method of claim 21 , comprising rotating the contact member in a first direction from a first position to a second position by rotating a core member or other member of the device coupled with the contact member.
26. The method of claim 21 , wherein the cavity is a space in a commissure of a mitral valve, and the method comprises reducing an annular diameter of the mitral valve or bringing a posterior leaflet closer to an anterior leaflet by reducing an annular space of the mitral valve.
27. The device of claim 1 , wherein the device is configured and operable to reshape, close, or occlude a cavity that comprises an opening, a hole, a cut, a slit, a vessel, a passageway, a chamber, a heart chamber, or a tissue void within a patient.
28. The device of claim 1 , wherein the device is configured and operable to reshape, close, or occlude a cavity that comprises a cavity of a stomach.
29. The device of claim 1 , wherein the device is configured and operable to reshape, close, or occlude a cavity that comprises a mitral valve or commissure of the mitral valve.
30. The device of claim 1 , wherein:
the device is configured and operable to reshape, close, or occlude a cavity that comprises a mitral valve or a commissure of the mitral valve;
the contact member is configured to rotate in at least the first direction from the first position to the second position to twist at least a portion of a tissue of the commissure of the mitral valve to draw the tissue in the commissure together to reduce a size of an annulus of the mitral valve.
31. The device of claim 30 , further comprising a second implant comprising a second contact member and a second securing element coupled with the second contact member, wherein:
the second contact member is configured to rotate to twist at least a portion of a tissue of a second commissure of the mitral valve to draw the tissue in the second commissure together to reduce the size of the annulus of the mitral valve; and
the second securing element is configured to prevent a rotation of the wall portion of the tissue of the second commissure when the second securing element is implanted in an operable state.
32. A method of reshaping a cavity, wherein the cavity is a commissure of a mitral valve, comprising:
advancing the contact member of the device of claim 1 into the commissure of the mitral valve;
engaging at least a portion of a tissue of the commissure of the mitral valve with the contact member; and
rotating the contact member in a first direction from a first position to a second position to twist at least the portion of the tissue of the commissure of the mitral valve to draw the tissue of the commissure together to reduce a size of an annulus of the mitral valve.
33. A method of reshaping a cavity, wherein the cavity is a commissure of a heart valve, comprising:
advancing the contact member of the device of claim 1 into a first commissure of the heart valve;
engaging at least a portion of a tissue of the first commissure of the heart valve with the contact member;
rotating the contact member in a clockwise direction to twist at least the portion of the tissue of the first commissure of the heart valve to draw the tissue of the first commissure together to reduce a size of an annulus of the heart valve;
advancing a second contact member into a second commissure of the heart valve, the second;
engaging at least a portion of a tissue of the second commissure of the heart valve with the second contact member; and
rotating the second contact member in a counter-clockwise direction from a first position of the second contact member to a second position of the second contact member to twist at least the portion of the tissue of the second commissure of the heart valve to draw the tissue of the second commissure together to reduce a size of an annulus of the heart valve; and
preventing the second contact member from rotating back to the first position of the second contact member.
34. The method of claim 33 , wherein preventing the contact member from rotating back to the first position of the contact member comprises engaging a tissue wall with an anchor element to prevent the contact member from rotating relative to the tissue wall.
35. A device for reshaping, closing, or occluding a cavity, comprising:
an implant comprising:
a contact member configured to move between a first state and a second state, the contact member having a shape selected from the group consisting of bulbous and spherical when in the second state, the contact member including one or more anchor features; and
a securing element coupled with the contact member;
wherein:
the contact member is configured to engage a wall portion of the cavity after the contact member has been advanced into the cavity;
the contact member is configured to rotate at least in a first angular direction from a first position to a second position;
the contact member is configured to twist at least a portion of the wall portion of the cavity in the first angular direction when the contact member is engaged with the wall portion of the cavity and is rotated from the first position to the second position to twist tissue of the wall portion of the cavity through engagement between the one or more anchor features and the tissue and thereby draw at least a first portion of the wall portion of the cavity toward a second portion of the wall portion of the cavity; and
the securing element is configured to prevent a rotation of the wall portion of the cavity in a second angular direction when the securing element is implanted in an operable state, to thereby maintain the tissue in a twisted state, wherein the second angular direction is opposite to the first angular direction.
36. A device for reshaping, closing, or occluding a cavity, comprising:
an implant comprising:
a contact member configured to move between a first state and a second state, the contact member including one or more anchor features, the contact member being positioned along a longitudinal axis; and
a securing element coupled with the contact member, the securing element being positioned along the longitudinal axis;
wherein:
the contact member is configured to engage a wall portion of the cavity after the contact member has been advanced into the cavity;
the contact member is configured to rotate at least in a first angular direction from a first position to a second position;
the contact member is configured to twist at least a portion of the wall portion of the cavity in the first angular direction when the contact member is engaged with the wall portion of the cavity and is rotated from the first position to the second position to twist tissue of the wall portion of the cavity through engagement between the one or more anchor features and the tissue and thereby draw at least a first portion of the wall portion of the cavity toward a second portion of the wall portion of the cavity; and
the securing element is configured to prevent a rotation of the wall portion of the cavity in a second angular direction when the securing element is implanted in an operable state, to thereby maintain the tissue in a twisted state, wherein the second angular direction is opposite to the first angular direction.