Patent Grant
11344310
The present application relates in general to medical devices. More specifically, the present application relates to tissue anchors and tool for manipulation of tissue anchors, such as for percutaneous use.
Tissue anchors are used to facilitate implantation of medical implants, such as by coupling such implants to tissue. A tissue anchor may be driven through the implant and into the tissue while the implant is held in place. Alternatively, the tissue anchor may be implanted before introduction of the medical implant, and the medical implant subsequently coupled to the tissue anchor.
Tissue anchor apparatus, and techniques for use thereof, are described. For some applications, a tool is described for manipulating tissue anchors. For some applications, the tool is configured for retrieval of already-implanted tissue anchors. For some applications, the tool is configured to be coupled to a tissue anchor at a non-zero angle with respect to the tissue anchor, and to subsequently be aligned with the tissue anchor. For some applications, the tool is configured to be advanced through a sleeve of an implant that has been implanted using tissue anchors, and to de-anchor at least one of the tissue anchors, thereby de-anchoring at least part of the sleeve from the tissue.
For some applications, a tissue anchor is described having a helical tissue-coupling element and an engaging head that comprises an eyelet. For some such applications, the tool is configured to be initially articulatably coupled to the tissue anchor (e.g., to the eyelet), and to be subsequently rigidly-coupled to the tissue anchor. For some such applications, the tool is configured to couple to the eyelet such that, together, the eyelet and an anchor-engaging element of the tool resemble links in a chain.
For some applications, an anchor driver is described for implanting the tissue anchor.
There is therefore provided, in accordance with an application of the present invention, apparatus for use with a tissue anchor, the apparatus including:
a first element including:
a second element, movable with respect to the first element such that, while (1) the portion of the tissue anchor is disposed within the space, and (2) the first element is in the closed state thereof:
In an application, in the open state, the distal portion of at least the second arm is disposed at an angle between 60 degrees and 80 degrees with respect to a longitudinal axis of the second element.
In an application, in the open state, the distal portion of at least the second arm protrudes away from the second portion and toward a central longitudinal axis of the apparatus.
In an application, the first arm and the second arm are disposed on a plane, and are more resistant to bending in-plane than off-plane.
In an application:
the first arm is shaped to define another concavity that defines at least part of the space, and
the first arm is coupled to the second arm such that the concavity defined by the first arm faces the concavity defined by the second arm.
In an application, the portion of the tissue anchor includes a bar that has a thickness, and the gap has a width that is at least 5 times greater than the thickness of the bar.
In an application:
the portion of the tissue anchor includes a bar that has a thickness, and
in the first position of the second element with respect to the first element the first arm and the second arm shape the space to define an aperture having a width that is at least 3 times greater than the thickness of the bar.
In an application:
the portion of the tissue anchor includes a bar that has a transverse cross-sectional area, and
in the first position of the second element with respect to the first element the first arm and the second arm shape the space to define an aperture defining an area that is at least 10 times greater than the transverse cross-sectional area of the bar.
In an application, in the first position of the second element with respect to the first element, the first arm and the second arm shape the space to define an aperture having (1) a depth, and (2) a width that is greater than the depth of the aperture.
In an application, the apparatus is configured such that, while (1) the portion of the tissue anchor is disposed within the space, and (2) the first element is in the closed state thereof:
when the first element is moved proximally, the first element applies a proximally-directed pulling force to the tissue anchor via contact between the first element and the portion of the tissue anchor, and
in the second position of the second element with respect to the first element, the second element is positioned to apply torque to the tissue anchor via contact between the first element and the tissue anchor.
In an application:
the second element includes a housing that defines a compartment,
in the first position, at least part of the first element is disposed outside of the compartment, and
the second element is movable from the first position to the second position such that at least part of the first element becomes disposed within the compartment.
In an application, in the open state of the first element, the gap is at least 1.5 times as great as a transverse width of the compartment.
In an application, the housing is configured to receive the portion of the tissue anchor at any of a plurality of rotational positions of the portion of the tissue anchor with respect to the housing.
In an application, the housing is configured to receive the portion of the tissue anchor at a continuum of rotational positions of the portion of the tissue anchor with respect to the housing, the continuum of rotational positions spanning at least 90 degrees.
In an application:
the portion of the tissue anchor includes a bar that defines at least part of an eyelet that defines a plane, the eyelet having a width on the plane,
the compartment has a transverse width that is greater than the width of the eyelet, and
the housing including one or more protrusions that protrude radially inward into the compartment such that a distance across the compartment between the protrusions is smaller than the width of the eyelet.
In an application:
the apparatus further includes an extracorporeal controller including a handle and an adjuster, the controller configured to move the second element with respect to the first element,
the adjuster is coupled to the housing via a tubular longitudinal member and is configured to reversibly move the at least part of the first element into and out of the compartment by reversibly moving the housing further and closer from the handle, and
the apparatus further includes a second longitudinal member that is disposed through tubular longitudinal member, and the handle is coupled to the first element via the second longitudinal member, such that a distance along the longitudinal member between the handle and the housing is fixed.
In an application, the housing is configured to move the first element from the open state to the closed state by moving with respect to the first element.
In an application, the apparatus is configured such that, when the second element moves from the first position to the second position, the housing inhibits movement of the portion of the tissue anchor within the space.
In an application:
the apparatus further includes:
while (1) the portion of the tissue anchor is disposed within the space, and (2) the first element is in the closed state thereof:
In an application, in the articulatably-coupled state, the distal portion of the tool is deflectable in at least 1 steradian with respect to the tissue anchor.
In an application, in the articulatably-coupled state, the distal portion of the tool is deflectable in at least 180 degrees with respect to the tissue anchor.
In an application, in the articulatably-coupled state, the tool is rotatable with respect to the tissue anchor.
In an application, the apparatus further includes (1) an implant including a sleeve, and (2) a tool for use with the tissue anchor, a distal portion of the tool including the first element and the second element, and:
the sleeve:
In an application, in the open state of the first element, the gap between the distal portion of the first arm and the distal portion of the second arm is at least 20 percent as great as a transverse cross-sectional width of the lumen.
In an application:
the tissue anchor is one of a plurality of tissue anchors,
the apparatus is for use with the plurality of tissue anchors,
the sleeve has a longitudinal axis, and is configured to be anchored to the tissue of the subject by the plurality of tissue anchors at a respective plurality of longitudinal sites of the sleeve, and
the distal portion of the tool is dimensioned to access the tissue anchor while at least another one of the plurality of tissue anchors is disposed between the tissue anchor and the proximal opening of the sleeve.
In an application, the apparatus further includes the tissue anchor, and:
the portion of the tissue anchor includes a bar that defines at least part of an eyelet that defines a plane,
the tissue anchor has a longitudinal axis that lies on the plane, and
the eyelet has a height along the longitudinal axis of the tissue anchor that is greater than a width of the eyelet, the width of the eyelet being on the plane and orthogonal to the longitudinal axis.
In an application, the bar is shaped to define an arch portion of the eyelet, and the arch portion is generally parabolic.
In an application, at least the first arm is curved.
In an application:
the apparatus further includes a tool having a distal end that includes the first element and the second element, and
the at least first arm is generally sigmoid and has an inwardly-convex proximal portion that curves away from a longitudinal axis of the distal end of the apparatus.
In an application, the curvature of the at least first arm defines an inwardly-concave portion that defines the concavity.
There is further provided, in accordance with an application of the present invention, apparatus, including:
a tissue anchor including a tissue-engaging element and a head that includes a bar having a transverse cross-sectional area; and
a tool including (1) a first part that includes an arm, and (2) a second part coupled to the first part such that:
There is further provided, in accordance with an application of the present invention, a method including:
sliding, through a catheter, an anchor-manipulating tool, while the anchor-manipulating tool is coupled to a tissue anchor and articulatable with respect to the tissue anchor;
inhibiting articulation between the anchor-manipulation tool and the tissue anchor; and
while the articulation is inhibited, using the anchor-manipulating tool, performing an action selected from the group consisting of: driving the tissue anchor into tissue of a subject, and removing the tissue anchor from tissue of the subject.
In an application, the step of inhibiting is performed subsequently to the step of sliding.
In an application, the step of inhibiting is performed prior to the step of sliding.
There is further provided, in accordance with an application of the present invention, apparatus for use with a tissue of a subject, the apparatus including:
a tissue anchor, including an engaging head and a tissue-coupling element, reversibly anchorable to the tissue; and
an anchor-retrieval tool, including:
In an application, the adjuster is configured to move at least part of the anchor-engaging element into and out of the compartment by reversibly moving the housing, with respect to the anchor-engaging element along a longitudinal axis of the anchor-manipulation tool.
In an application, the engaging head includes a bar that defines an eyelet that has a width, and the compartment has a transverse width that is greater than the width of the eyelet.
In an application:
the one or more arms include at least a first arm and a second arm that define a space therebetween, and
the controller is configured to reversibly move the first arm and the second arm between (1) a first state in which a gap between a distal portion of the first arm and a distal portion of the second arm is at least 5 times greater than a thickness of the bar, and (2) a second state in which the gap is smaller than the thickness of the bar, and the space between the first arm and the second arm defines an aperture that has a width that is at least 3 times greater than the thickness of the bar.
In an application, a thickness of the one or more arms defines a depth of the aperture, and the width of the aperture is greater than the depth of the aperture.
In an application, the anchor-retrieval tool has a distal end that includes the anchor-engaging element and the housing, and the apparatus has at least two states, including:
an uncoupled state in which the anchor-engaging element is not in contact with the tissue anchor, and
an articulatably-coupled state in which:
In an application, the engaging head includes an eyelet, and the controller is configured to facilitate transition of the apparatus from the uncoupled state to the articulatably-coupled state by moving at least part of the one or more arms through the eyelet
In an application, the at least two states further include a rigidly-coupled state in which the distal end of the anchor-retrieval tool is inhibited from deflecting with respect to the tissue anchor.
In an application, the adjuster is configured to move the apparatus from the articulatably-coupled state into the rigidly-coupled state by moving at least part of the engaging head into the compartment by moving the at least part of the anchor-engaging element into the compartment.
In an application, when the apparatus is in the rigidly-coupled state, the anchor-manipulation tool is configured to apply a de-anchoring force the tissue anchor.
In an application, the anchor-manipulation tool is configured to apply a rotational de-anchoring force to the anchor.
In an application, the anchor-manipulation tool is configured to apply the rotational de-anchoring force by the housing rotating around a longitudinal axis of the anchor-manipulation tool.
In an application, the one or more arms are curved.
In an application, the one or more arms include exactly one arm.
In an application, the exactly one arm is shaped to define a hook.
In an application, the controller is configured to move the housing, with respect to the hook, along a longitudinal axis of the anchor-manipulation tool.
There is further provided, in accordance with an application of the present invention, apparatus for use with a tissue of a subject, the apparatus including:
a tissue anchor including an engaging head including an eyelet, and a tissue-coupling element reversibly anchorable to the tissue; and
an anchor-manipulation tool:
In an application, the curved arm is generally helical, and is configured to be coupled to the eyelet by being rotated with respect to the eyelet.
In an application, the tissue-coupling element is generally helical and has a handedness, and the curved arm has a handedness that is opposite to the handedness of the tissue-coupling element.
In an application, the anchor-engaging element includes at least a first arm and a second arm, the curve of each of the arms defining a respective concavity, and the arms positioned such that the concavity of the first arm faces the concavity of the second arm.
In an application, the anchor-engaging element further includes a housing that defines a compartment therein, and an adjuster that is configured to move at least part of each of the arms into and out of the compartment.
In an application,
when the anchor-engaging element is coupled to the tissue anchor, the anchor-manipulation tool is configured to move at least part of the eyelet into the compartment by the at least part of each of the arms moving into the compartment, and
the housing is configured to apply the rotational de-anchoring force to the tissue anchor by the housing being rotated while the at least part of the eyelet is disposed within the compartment.
In an application, the anchor-engaging element is configured to be coupled to the tissue anchor by being rotated with respect to the tissue anchor, and the anchor-manipulation tool is configured to apply the rotational de-anchoring force to the tissue anchor by at least part of the anchor-engaging element being rotated with respect to the tissue anchor.
In an application, the anchor-engaging element further includes a housing that defines a compartment therein, and an adjuster that is configured to move at least part of the arm into and out of the compartment.
In an application,
when the anchor-engaging element is coupled to the tissue anchor, the anchor-manipulation tool is configured to move at least part of the eyelet into the compartment by the at least part of the arm moving into the compartment, and
the housing is configured to apply the rotational de-anchoring force to the tissue anchor by the housing being rotated while the at least part of the eyelet is disposed within the compartment.
In an application, the curved arm is generally helical, is configured to be coupled to the eyelet by being rotated with respect to the eyelet, and is configured to apply the rotational de-anchoring force to the tissue anchor by being further rotated with respect to the eyelet.
There is further provided, in accordance with an application of the present invention, apparatus for use with a tissue of a subject, the apparatus including:
a tissue anchor, including:
an anchor driver, having a distal portion that is transluminally advanceable toward the tissue, and including:
the anchor driver being configured to anchor the tissue anchor to the tissue by rotating the tissue anchor by applying a rotational force to the eyelet.
In an application, the slot is dimensioned to receive the at least part of the eyelet snugly.
In an application, the anchor driver further includes a controller, configured to move the detent between (i) a closed state in which the at least part of the eyelet is inhibited from exiting the slot, and (ii) an open state in which the at least part of the eyelet is slidable out of the slot.
In an application:
the casing defines a recess,
at least part of the detent moves into the recess when the detent moves into the open state thereof, and
the controller includes a rod, configured to move the detent into the closed state thereof by the rod being slid into at least part of the recess.
In an application, the apparatus further includes an anchor-retrieval tool, transluminally advanceable independently of the anchor driver.
In an application, the anchor-retrieval tool includes:
an anchor-engaging element including one or more arms, configured to be coupled to the engaging head,
a housing that defines a compartment therein, and
a retrieval-tool controller, including an adjuster configured to move at least part of the anchor-engaging element into and out of the compartment.
In an application, the anchor-retrieval tool:
includes, at a distal portion thereof, an anchor-engaging element including a curved arm, configured to be coupled to the tissue anchor by moving through the eyelet, and
is configured, while the anchor-engaging element is coupled to the tissue anchor, to apply a rotational de-anchoring force to the tissue anchor.
In an application:
the anchor-retrieval tool includes:
the anchor-engaging-element actuator is configured to facilitate transition of the apparatus from the uncoupled state to the articulatably-coupled state, and
the anchor-retrieval tool, in at least one of the at least two states, being configured to apply a de-anchoring force the tissue anchor.
There is further provided, in accordance with an application of the present invention, apparatus, including:
an implant including a sleeve that includes a lateral wall that defines a lumen having a transverse cross-sectional diameter, and configured to be transluminally implanted in a subject;
at least one tissue anchor including a coupling head and a tissue-engaging element, configured to be transluminally advanced to the implant, and to anchor the implant in the subject by the tissue-engaging element being driven through the lateral wall and into a tissue of the subject; and
an anchor-retrieval tool including an anchor-engaging element including two arms, the anchor-engaging element configured:
to be transluminally advanced to the implant and into the lumen of the implant,
to be moved into a position in which a gap between respective distal portions of the two arms is at least 20 percent as great as the transverse cross-sectional diameter of the lumen,
to be subsequently coupled to the coupling head, and
to subsequently apply a de-anchoring force to the tissue anchor.
In an application, the anchor-engaging element is configured to be moved into a position in which a gap between respective distal portions of the two arms is at least 50 percent as great as the transverse cross-sectional diameter of the lumen.
In an application, the anchor-engaging element is configured to be moved into a position in which a gap between respective distal portions of the two arms is at least 80 percent as great as the transverse cross-sectional diameter of the lumen.
There is further provided, in accordance with an application of the present invention, apparatus for use with a tissue of a subject, the apparatus including:
a tissue anchor, including an engaging head and a tissue-coupling element, and reversibly anchorable to the tissue; and
an anchor-manipulation tool including:
an uncoupled state in which the anchor-engaging element is not in contact with the tissue anchor, and
an articulatably-coupled state in which:
In an application, in the articulatably-coupled state, the distal portion of the anchor-manipulation tool is rotatable with respect to the tissue anchor.
In an application, the anchor-manipulation tool is configured to rotate the tissue anchor by applying the de-anchoring force to the tissue anchor.
In an application, the at least two states further include a rigidly-coupled state in which the distal portion of the anchor-manipulation tool is inhibited from deflecting with respect to the tissue anchor.
In an application, the anchor-manipulation tool is configured to apply the de-anchoring force to the tissue anchor while the apparatus is in the rigidly-coupled state.
In an application, the anchor-engaging-element actuator is configured to transition the apparatus from the articulatably-coupled state to the rigidly-coupled state.
In an application, the anchor-engaging-element actuator is configured to transition the apparatus from the articulatably-coupled state to the rigidly-coupled state by sliding, with respect to the anchor-engaging element, along a longitudinal axis of the distal portion of the tool.
In an application, in the articulatably-coupled state, the distal portion of the anchor-manipulation tool is deflectable in at least 1 steradian with respect to the tissue anchor.
In an application, in the articulatably-coupled state, the distal portion of the anchor-manipulation tool is deflectable in at least 3 steradians with respect to the tissue anchor.
In an application, in the articulatably-coupled state, the distal portion of the anchor-manipulation tool is deflectable in at least 7 steradians with respect to the tissue anchor.
There is further provided, in accordance with an application of the present invention, a method for use with a tissue anchor that is implanted in a tissue of a subject, the method including:
advancing a tool toward the tissue anchor;
coupling the tool to the tissue anchor such that a longitudinal axis of the tool is disposed at a nonzero angle with respect to a longitudinal axis of the tissue anchor; and
subsequently aligning the longitudinal axis of the tool with the longitudinal axis of the tissue anchor.
In an application, at least a portion of the tissue anchor is disposed within a sleeve of an implant, and couples at least a portion of the implant to the tissue, and advancing the tool toward the tissue anchor includes advancing the tool at least partly through the sleeve of the implant.
In an application, aligning the longitudinal axis of the tool with the longitudinal axis of the tissue anchor includes aligning the longitudinal axis of the tool with the longitudinal axis of the tissue anchor by deforming the tissue of the subject.
In an application, deforming the tissue includes deforming the tissue by applying a force to the tissue anchor using the tool.
In an application, the tissue anchor includes an eyelet and the tool includes an anchor-engaging element and a housing that is slidable over the anchor-engaging element, and the method further includes facilitating aligning the longitudinal axis of the tool with the longitudinal axis of the tissue anchor by sliding the housing over at least part of the eyelet.
In an application, coupling the tool to the tissue anchor includes articulatably coupling the tool to the tissue anchor.
In an application, the method further includes, subsequently to aligning the longitudinal axis of the tool with the longitudinal axis of the tissue anchor, inhibiting articulation of the tissue anchor with respect to the tool.
In an application, inhibiting the articulation includes inhibiting the articulation by sliding a portion of the tool over a portion of the tissue anchor.
In an application, the tissue anchor includes an eyelet and the tool includes an anchor-engaging element and a housing that is slidable over the anchor-engaging element, and inhibiting the articulation includes inhibiting the articulation by sliding the housing over at least part of the eyelet.
In an application, the method further includes, subsequently to aligning the longitudinal axis of the tool with the longitudinal axis of the tissue anchor, applying a force to the anchor using the tool.
In an application, the method further includes de-anchoring the anchor from the tissue by applying the force to the anchor.
In an application, applying the force includes applying a rotational force to the anchor.
In an application, applying the rotational force to the anchor includes applying the rotational force to the anchor by rotating the tool, and the method further includes (1) after aligning the longitudinal axis of the tool with the longitudinal axis of the anchor, and (2) before applying the rotational force to the anchor, rotating the tool without applying the rotational force to the anchor.
There is further provided, in accordance with an application of the present invention, apparatus for use with a tissue anchor, the tissue anchor including a tissue-coupling element and a bar that defines at least part of a coupling eyelet coupled to the tissue-coupling element, the coupling eyelet having a width, the apparatus including:
a housing:
at least two arms including at least a first arm and a second arm, each of the arms defining a distal portion thereof, the arms defining a space therebetween, and being movable between:
the apparatus being configured such that as the arms move from the extended position toward the retracted position, the arms form the loop before reaching the retracted position.
In an application, the first arm and the second arm are disposed on a plane, and are more resistant to bending in-plane than off-plane.
In an application, the transverse width of the compartment is between 5 percent and 30 percent greater than the width of the eyelet.
In an application, the apparatus is configured to be advanced percutaneously into a subject.
In an application, in the extended position, the distal portion of each arm is disposed an angle between 60 degrees and 80 degrees with respect to the longitudinal axis.
In an application, the compartment defined by the inner surface of the housing is generally cylindrical, and the transverse width of the compartment includes a transverse diameter of the compartment.
In an application, the arms are configured to progressively form the loop responsively to being progressively moved into the compartment.
In an application, the compartment is generally cylindrical, and the transverse width includes a transverse diameter of the generally cylindrical compartment.
In an application, the tissue anchor has a longitudinal axis, the apparatus has a longitudinal axis, and the apparatus is configured to engage the coupling eyelet of the tissue anchor by the bar moving through the gap into the space, at any of at least 180 degrees of deflection of the longitudinal axis of the apparatus in a plane in which the longitudinal axis of the tissue anchor lies, and at any of at least 300 degrees of deflection of the longitudinal axis of the apparatus around the longitudinal axis of the tissue anchor.
In an application, the housing is configured to receive the eyelet at any of a plurality of rotational positions of the eyelet with respect to the housing.
In an application, the housing is configured to receive the eyelet at a continuum of rotational positions of the eyelet with respect to the housing.
In an application:
the at least two protrusions include a first protrusion and a second protrusion,
the apparatus has a longitudinal axis,
the first protrusion and the second protrusion define a transverse axis therebetween, the transverse axis being orthogonal to the longitudinal axis of the apparatus,
the eyelet defines a plane, and
the housing is configured to receive the eyelet at a continuum of rotational positions of the plane of the eyelet with respect to the transverse axis, the continuum of rotational positions spanning at least 90 degrees around the longitudinal axis of the apparatus.
In an application, the housing is configured such that the continuum of rotational positions spans at least 150 degrees around the longitudinal axis of the apparatus.
In an application, the housing is configured to receive the eyelet at one or more continua of rotational positions of the plane of the eyelet, that span a total of at least 270 degrees around the longitudinal axis of the apparatus, with respect to the transverse axis.
In an application, the apparatus further includes an extracorporeal controller, including a handle and an adjuster, the adjuster being configured to move the arms between the extended position and the retracted position.
In an application:
the adjuster is coupled to the housing via a tubular longitudinal member, and is configured to reversibly move the arms between the extended position and the retracted position by reversibly moving the housing further and closer from the handle, and
the handle is coupled to the arms via a longitudinal member that passes through the tubular longitudinal member, such that a distance along the longitudinal member between the handle and the housing is fixed.
In an application, the handle is coupled to a proximal end of the longitudinal member that is exposed from a proximal end of the tubular longitudinal member.
In an application, the extracorporeal controller includes an indicator that indicates at least a state of the adjuster in which (1) the arms define the loop, and (2) the arms are not in the retracted position.
In an application, as the arms move from the extended position toward the retracted position, the arms deflect toward each other such that the distal portion of the first arm becomes closer to the distal portion of the second arm.
In an application, the distal portion of each arm defines a respective beveled edge, and the arms are configured such that when the arms move into the retracted position, the beveled edge of first arm mates with the beveled edge of the second arm.
In an application, a proximal portion of the first arm is coupled to a proximal portion of the second arm.
In an application, the arms are biased toward deflecting away from each other.
In an application, the proximal portion of the first arm is fixedly coupled to the proximal portion of the second arm, and each arm includes a resilient material, and is configured to progressively bend responsively to being progressively moved into the compartment.
In an application, in the extended position, the gap between the distal portion of the first arm and the distal portion of the second arm is greater than the transverse width of the compartment.
In an application, in the extended position, the gap between the distal portion of the first arm and the distal portion of the second arm is at least 1.5 times as great as the transverse width of the compartment.
In an application, the apparatus includes the tissue anchor.
In an application, the tissue anchor includes a base that couples the eyelet to the tissue-coupling element.
In an application, the tissue anchor has a longitudinal axis, and the eyelet has a height along the longitudinal axis that is at least 80 percent as great as the width of the eyelet.
In an application, the height of the eyelet is approximately equal to the width of the eyelet.
In an application, the height of the eyelet is greater than the width of the eyelet.
In an application, the height of the eyelet is at least 50 percent greater than the width of the eyelet.
In an application, the bar is shaped to define an arch portion of the eyelet, a crest of the arch portion being further from the tissue-coupling element than is a base of the arch portion.
In an application, the arch portion is generally parabolic.
In an application, the tissue anchor has a longitudinal axis, the eyelet has a height along the longitudinal axis, and any portion of the bar that is parallel to the longitudinal axis has a height along the longitudinal axis that is less than 50 percent of the height of the eyelet.
In an application, the arms are configured to be coupled to the coupling eyelet by trapping the at least part of the bar within the aperture by forming the loop while the at least part of the bar is disposed in the space between the arms.
In an application, the arms are configured to be articulatably coupled to the coupling eyelet.
In an application, the apparatus is configured such that, while the arms are coupled to the eyelet, when the arms move into the retracted position, at least part of the eyelet moves into the compartment.
In an application, the apparatus further includes the tissue anchor, the bar of the eyelet has a curvature, and the curvature of the bar of the eyelet facilitates the at least part of the eyelet moving into the compartment.
In an application, the apparatus further includes an overtube, slidable over the housing and, while the at least part of the eyelet is disposed within the compartment, slidable over at least part of the tissue anchor.
In an application, the apparatus is configured such that, when the at least part of the eyelet moves into the compartment, the housing inhibits articulation of the coupling eyelet with respect to the arms.
In an application, the apparatus is configured such that, while the at least part of the eyelet is disposed within the compartment, rotation of the housing with respect to the anchor presses the protrusions against the bar of the eyelet.
In an application, the apparatus is configured such that, while the at least part of the eyelet is disposed within the compartment, and the protrusions are pressed against the bar of the eyelet, further rotation of the housing with respect to the anchor rotates the anchor.
In an application, the apparatus includes the tissue anchor, and the tissue-coupling element of the tissue anchor includes a helical tissue-coupling element.
In an application, the apparatus is configured to facilitate screwing of the tissue-coupling element into tissue of a subject.
In an application, the apparatus is configured to facilitate unscrewing of the tissue-coupling element from tissue of a subject.
In an application, when the arms are coupled to the coupling eyelet, the loop and the eyelet resemble links in a chain.
In an application:
the arms each further define a proximal stem portion, a distal end of the proximal stem portion being coupled to the distal portion of the respective arm,
the housing has a central longitudinal axis from a proximal end to the distal end thereof,
in the extended position:
In an application, in the extended position, the distal portion of each arm protrudes from the distal end of the proximal stem portion distally away from the housing.
There is further provided, in accordance with an application of the present invention, apparatus, including:
a tissue anchor, having a longitudinal axis and including an engaging head, shaped to define an opening,
a tool having a longitudinal axis, and including:
an articulatably-coupled state in which at least one of the arms of the tool is hooked through the opening, and the longitudinal axis of the tool is movable with respect to the longitudinal axis of the anchor, and
a rigidly-coupled state in which the arm actuator inhibits movement of the longitudinal axis of the tool with respect to the longitudinal axis of the anchor by pushing on the arms.
In an application, the engaging head is shaped to define an opening that has a first end and a second end, and is narrower at the first end than at the second end.
There is further provided, in accordance with an application of the present invention, a method for use with a tissue anchor that is implanted in a tissue of a subject, the method including:
advancing a tool toward the tissue anchor;
articulatably coupling the tool to the tissue anchor;
subsequently changing an alignment of a longitudinal axis of the tool with respect to a longitudinal axis of the tissue anchor; and
subsequently rigidly coupling the tool to the tissue anchor.
There is further provided, in accordance with an application of the present invention, a tissue anchor for coupling to tissue of a subject using a tool, the tissue anchor including:
a helical tissue-coupling element:
an eyelet:
There is further provided, in accordance with an application of the present invention, apparatus, including:
an anchor-manipulation tool including a tissue-anchor-engaging element, the tissue-anchor-engaging element including:
In an application, the apparatus further includes a tissue anchor including an engaging head having a wall shaped so as to define an opening shaped so as to define a funnel having a wide proximal end and a narrow distal end, and:
the engaging head is shaped to define an undercut at the narrow distal end, and
the engaging head is shaped so as to define one or more recesses at the narrow distal end in a vicinity of the undercut.
There is further provided, in accordance with an application of the present invention, a method, including:
providing an anchor-manipulation tool including:
moving the distal hook away from the longitudinal axis by the curved arm to an opened state by pushing the plunger distally to a distal position in which the proximal portion of the force applicator is disposed adjacently to the central hook portion of the curved arm and the proximal portion of the curved arm inclines toward the longitudinal element.
There is further provided, in accordance with an application of the present invention, apparatus, including:
a tissue anchor including an engaging head having a wall shaped so as to define an opening shaped so as to define a funnel having a wide proximal end and a narrow distal end, the engaging head being shaped to define an undercut at the narrow distal end, the wall of the engaging head being shaped so as to define one or more grooves at the narrow distal end proximal to the undercut;
an anchor manipulating tool having a tissue-anchor-engaging element configured to engage the wall of the engaging head, the tool having one or more engaging structures, each of the one or more engaging structures including:
an annular element coupled to the distal end of the tool configured to facilitate positioning of the tissue-anchor-engaging element with respect to the wall of the engaging head.
The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:
Reference is made to
Anchor 40 has a central longitudinal axis a1, from a distal end of tissue-coupling element 42 to a proximal end of eyelet 46. Typically, a central helix axis of helical tissue-coupling element 42 is coaxial with axis a1. Eyelet 46 typically defines a plane a4 (see also
Tool 80 further comprises an anchor-engaging element 91 comprising one or more (e.g., two) arms 92, each arm defining a proximal stem portion 93 and distal portion 94 (e.g., a distal hook portion), and the arms typically curving inwardly toward each other so as to define a space 96 therebetween (e.g., between respective proximal stem portions). That is, the curve of each arm defines a concavity 103, and the concavity of each arm faces the concavity of the other arm, so as to define at least part of space 96. Alternatively, stem portion 93 may be generally straight. It is to be noted, that even for applications in which stem portion 93 is generally straight, arm 92 would typically still define a concavity at a site 104 where portion 93 meets distal portion 94.
Typically, width d6 is greater than thickness d3 of bar 44 of eyelet 46 of anchor 40 (e.g., at least 5 times as great as thickness d3, such as at least 10 times as great as thickness d3, such as at least 20 times as great as thickness d3). Width d6 is further typically greater than width d4 of compartment 86, e.g., at least 1.5 times as great, less than 4 times as great, and/or between 1.5 times and 4 times as great. Arms 92 (e.g., portion 93 and/or portion 94 thereof) have a thickness d7 that is typically less than 0.5 times as great (e.g., less than 0.2 times as great, such as less than 0.1 times as great) as width d6, and/or less than width d4 (e.g., less than 0.5 times as great as width d4, such as less than 0.2 times as great as width d4).
For some applications, a plane a5 on which arms 92 lie is typically disposed at least 20 degrees, up to 90 degrees, and/or between 20 and 90 degrees with respect to a transverse axis a3 between protrusions 90. For example, and as shown in
In the extended position, stem portion 93 of each arm 92 typically protrudes distally away from housing 82 and outward from a longitudinal axis a2 of tool 80, and distal portion 94 of each arm protrudes from a distal end of the stem portion and inward toward the longitudinal axis. Further typically, distal portion 94 of each arm protrudes from the distal end of stem portion 93 distally away from the housing. Distal portion 94 (e.g., an inner surface thereof) is disposed at an angle alpha_A with respect to longitudinal axis a2, angle alpha_A typically being greater than 40 degrees, less than 85 degrees, and/or between 40 and 85 degrees (e.g., between 50 and 80 degrees, such as between 50 and 70 degrees and/or between 70 and 80 degrees). Due at least in part to these geometries, arms 92 typically do not define effective hooks while in the extended position. It is hypothesized that such a configuration reduces a likelihood of arms 92 inadvertently hooking to tissue or apparatus within the body of the subject.
Arms 92 further have a retracted position in which at least part of distal portion 94 of each arm is typically disposed inside compartment 86, as shown in
As arms 92 move from the extended position toward the retracted position, the arms deflect toward each other such that distal portions 94 become closer to each other (e.g., such that a distance between the distal portions is smaller than thickness d3 of bar 44. Typically, distal portions 94 are at least 10 times further (e.g., at least 20 times further) from each other when in the extended position than when in the retracted position. Further typically, in at least the retracted position (and still further typically also in the intermediate position), the distal portion of one arm is in contact with the distal portion of another (e.g., the other) arm. For some applications, each distal portion is shaped to define a beveled edge, so as to facilitate contact (e.g., mating) of the distal portions. For example, when the arms move into the intermediate position and/or the retracted position, at least part of the beveled edge of one arm moves past at least part of the beveled edge of the other arm. The beveled edges and the resulting mating is shown most clearly in
As arms 92 move toward the intermediate position and/or the retracted position, the angle at which distal portion 94 is disposed with respect to longitudinal axis a2 approaches, and typically passes, 90 degrees, such that each arm forms a hook (e.g., as shown in
Tool 80 further comprises an extracorporeal controller 110, which comprises a handle 112 and an adjuster 114, such as a switch or a lever. Adjuster 114 is configured to move arms 92 between the extended and retracted states. As described with reference to
As shown in
Reference is made to
Typically, aperture 97 (1) defines an area that is at least 10 times greater (e.g., at least 20 times greater, such as at least 40 times greater) than that of a transverse cross-sectional area of bar 44 of anchor 40, (2) has a width d8 (see
For some applications, tool 80 (e.g., anchor-engaging element 91 thereof) comprises only one arm, and bar 44 is trapped by the one arm, e.g., by being hooked by the one arm, and/or by being trapped between the one arm and inner surface 84 of compartment 86. For some applications, tool 80 comprises two arms, but only one of the arms defines a concavity. For example, the other one of the arms may be straight, and the space between the arms is shaped to define an asymmetric aperture when distal portion 94 of the arm that defines the concavity comes into contact with a distal portion of the straight arm (e.g., as described with reference to
It is to be further noted that tool 80 is shown having been advanced toward, and coupled to eyelet 46 with a longitudinal axis a2 of the tool (e.g., of housing 82) at a nonzero angle of attack with respect to longitudinal axis a1 of anchor 40.
The above possible angles of attack of tool 80 may also be translated into three-dimensional terms. For example, the possible angles of attack of tool 80 typically, together, define a three-dimensional angular span of at least 1 steradian (e.g., at least 3 steradians, such as at least 7 steradians) around eyelet 46. Such a span is illustrated schematically, by way of example, as span 102 in
While system 100 is in the articulatably-coupled state (e.g., while tool 80 is articulatably coupled to anchor 40), tool 80 is deflectable with respect to anchor 40. Typically, in this state, tool 80 is deflectable into any of the angles described hereinabove as angles of attack. For example, tool 80 is typically deflectable into any angle that lies within the three-dimensional angular span(s) that are described with reference to
For some applications, such as when an angle between axes a1 and a2 is relatively large, tool 80 is subsequently manipulated so as to reduce the angle between axes a1 and a2, e.g., to at least in part align the tool and anchor 40 (
Subsequently, arms 92 are moved into the retracted position, typically by housing 82 being slid over the arms (e.g., while arms 92 remain stationary), and thereby also over at least part of (e.g., most of, or all of) eyelet 46 (
Housing 82 is configured to receive eyelet 46 at a plurality of rotational positions (e.g., a continuum of rotational positions) with respect to the housing. Portions of bar 44 of eyelet 46 become disposed in a circumferential space between protrusions 90. For example, and as shown in
Although as described in the above paragraph housing 82 is configured to receive eyelet 46 at a plurality (e.g., a continuum) of rotational positions with respect to the housing, the orientation of arms 92 (e.g., plane a5 thereof) with respect to protrusions 90 (e.g., axis a3 therebetween) may bias the eyelet (e.g., plane a4 thereof) to be oriented in a particular rotational position with respect to the housing. For example, and as shown in
As described hereinabove, in the intermediate position, arms 92 are articulatably coupled to eyelet 46. The compartment of housing 82 is typically dimensioned such that the eyelet fits generally snugly therewithin. Thereby movement of eyelet 46 into the compartment of housing 82 typically inhibits articulation of the eyelet with respect to the arms. The state of system 100 shown in
Subsequently, as shown in
It is to be noted that, although
Reference is made to
Tool 80 is typically used to retrieve anchor 40 percutaneously (e.g., transluminally). Housing 82, tubular longitudinal member 116 and longitudinal member 120 are thereby configured to be percutaneously advanced to a site at which anchor 40 is implanted. For example, when tool 80 is configured to transluminally retrieve anchor 40, housing 82, tubular longitudinal member 116 and longitudinal member 120 are dimensioned to fit within the blood vessel(s) through which they are to be advanced, and the tubular longitudinal member and the longitudinal member are sufficiently flexible to follow the transluminal route.
Typically, extracorporeal controller 110 comprises and/or defines an indicator 124 that indicates a state of adjuster 114, and thereby the position of arms 92. Indicator 124 may comprise a visual indicator, such as markings, and/or may comprise a tactile indicator, such as graduated ridges 126 with which a part of adjuster 114 interfaces. Indicator 124 typically indicates at least a state of adjuster 114 in which arms 92 are in the intermediate position in which they define the loop but are not in the retracted position. Indicator 124 may also indicate one or more states of adjuster 114 in which arms 92 are between the extended position and the intermediate position (e.g., partially closed), e.g., so as to facilitate advancement of tool 80 through a narrow lumen. Indicator 124 (e.g., ridges 126 thereof) may be configured to partially hold adjuster 114 in one or more states, such as in the state in which arms 92 are in the intermediate position.
Reference is again made to
Reference is made to
Arms 92 are typically disposed on a plane a5 (e.g., when in a relaxed and/or unconstrained state). For some applications, arms 92 are more resistant to bending in plane a5 (i.e., in-plane) than away from plane a5 (i.e., off-plane). For some such applications, when forked member 140 defines arms 92 and comprises a resilient material, the material is more flexible off-plane than it is in-plane.
Reference is now made to
For some applications, annuloplasty ring structure 222 is implanted, mutatis mutandis, using techniques described in U.S. application Ser. No. 12/437,103, filed May 7, 2009 which published as US 2010/0286767, and which issued as U.S. Pat. No. 8,715,342, and/or US application Ser. No. 12/689,635, filed Jan. 19, 2010 which published as US 2010/0280604, and which issued as U.S. Pat. No. 8,545,553, both of which are assigned to the assignee of the present application and are incorporated herein by reference.
For some applications, annuloplasty ring structure 222 is implanted, mutatis mutandis, using techniques described in U.S. Provisional Application 61/717,303, which is assigned to the assignee of the present application and is incorporated herein by reference.
Annuloplasty ring structure 222 comprises an adjusting mechanism 246. The adjusting mechanism comprises a rotatable structure, such as a spool, arranged such that rotation of the rotatable structure contracts the implant structure. The implant further comprises a longitudinal member 286, such as a wire, which is coupled to the adjusting mechanism. A rotation tool (not shown) is provided for rotating the rotatable structure. The tool is configured to be guided along (e.g., over, alongside, or through) longitudinal member 286, to engage the rotatable structure, and to rotate the rotatable structure in response to a rotational force applied to the tool.
The procedure typically begins by advancing a semi-rigid guidewire into a right atrium 220 of the patient. The procedure is typically performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and/or echocardiography. The guidewire provides a guide for the subsequent advancement of an outer steerable catheter 212 therealong and into the right atrium. Catheter 212 typically comprises a 14-24 F sheath, although the size may be selected as appropriate for a given patient. Catheter 212 is advanced through vasculature into the right atrium using a suitable point of origin typically determined for a given patient. For example:
For some applications of the present invention, catheter 212 is advanced through inferior vena cava 223 of the patient (as shown) and into right atrium 220 using a suitable point of origin typically determined for a given patient.
Catheter 212 is advanced distally until the sheath reaches the interatrial septum, and a resilient needle and a dilator (not shown) are advanced through catheter 212 and into the heart. In order to advance catheter 212 transseptally into left atrium 224, the dilator is advanced to the septum, and the needle is pushed from within the dilator and is allowed to puncture the septum to create an opening that facilitates passage of the dilator and subsequently catheter 212 therethrough and into the left atrium. The dilator is passed through the hole in the septum created by the needle. Typically, the dilator is shaped to define a hollow shaft for passage along the needle, and the hollow shaft is shaped to define a tapered distal end. This tapered distal end is first advanced through the hole created by the needle. The hole is enlarged when the gradually increasing diameter of the distal end of the dilator is pushed through the hole in the septum. The advancement of catheter 212 through the septum and into the left atrium is followed by the extraction of the dilator and the needle from within catheter 212.
As shown in
Typically, a channel 218 is provided disposed snugly within sleeve 228, and anchor driver 236 delivers anchors 40 via the channel. Channel 218 is more rigid than sleeve 228, and is progressively slid out of the sleeve as subsequent anchors 40 are delivered. Anchors 40 are typically deployed from a distal end of manipulator 261 while the distal end is positioned such that a central longitudinal axis through the distal end of manipulator 61 forms an angle with a surface of the cardiac tissue of between about 20 and 90 degrees, e.g., between 45 and 90 degrees, such as between about 75 and 90 degrees, such as about 90 degrees. Typically, anchors 40 are deployed from the distal end of manipulator 261 into the cardiac tissue in a direction parallel to the central longitudinal axis through the distal end of manipulator 261. Such an angle is typically provided and/or maintained by channel 218 being more rigid than sleeve 228. The distal end of channel 218 is typically brought close to the surface of the cardiac tissue (and the wall of sleeve 228 that is disposed against the surface of the cardiac tissue), such that little of each anchor 40 is exposed from the channel before penetrating the sleeve and the tissue. For example, the distal end of channel 218 may be placed (e.g., pushed) against the wall of the sleeve, sandwiching the sleeve against the cardiac tissue.
For some applications, this placement of the distal end of channel 218 against the cardiac tissue (via the wall of the sleeve), stabilizes the distal end during deployment and anchoring of each anchor 40, and thereby facilitates anchoring. For some applications, pushing of the distal end of channel 218 against the cardiac tissue (via the wall of the sleeve) temporarily deforms the cardiac tissue at the site of contact. This deformation may facilitate identification of the site of contact using imaging techniques (e.g., by identifying a deformation in the border between cardiac tissue and blood), and thereby may facilitate correct positioning of the anchor.
For some applications of the present invention, anchors 32 may be deployed from a lateral portion of manipulator 261.
As shown in
Typically, the first anchor is deployed most distally in the sleeve (generally at or within a few millimeters of the distal tip of the sleeve), and each subsequent anchor is deployed more proximally, such that the sleeve is gradually decoupled from channel 218 in a distal direction during the anchoring procedure (i e, channel 218 is withdrawn from within sleeve 228, so as to make the successive proximal portion sleeve 228 ready for implantation of a subsequent anchor). The already-deployed first anchor 40a holds the anchored end of sleeve 228 in place, so that the sleeve is drawn from the site of the first anchor towards the site of the second anchor.
As shown in
Once the desired level of adjustment of structure 222 is achieved (e.g., by monitoring the extent of regurgitation of the valve under echocardiographic and/or fluoroscopic guidance), the rotation tool and guide member 286 are removed from the heart. For some applications, a distal portion of guide member 286 may be left within the heart of the patient and the proximal end may be accessible outside the body, e.g., using a port. For such applications, adjusting mechanism 246 may be accessed at a later stage following initial implantation and adjustment of ring structure 222.
For some applications, a re-access wire 288 may be provided, coupled to a proximal portion of the implant (e.g., a portion of the implant that is deployed last), such as to a last anchor (as shown in
Alternatively, annuloplasty ring structure 222 is implanted by right or left thoracotomy, mutatis mutandis.
Reference is made to
Should it be necessary to remove an anchor, such as anchor 40d, tool 80 may be advanced through channel 166 so as to access lumen 164, and thereby the anchor (e.g., as shown in
For some applications, tool 80 may be guided to annuloplasty ring structure 161 and/or into lumen 164 thereof by being advanced along a re-access wire 288 (shown for structure 222 in
For some applications, should it be necessary to remove an anchor other than the most recently-deployed anchor, tool 80 may be coupled to that anchor by being advanced past more recently-deployed anchors. For example, as shown in
For some applications, flexibility of tubular longitudinal member 116 facilitates advancement of tool 80 through lumen 164, e.g., past bends in sleeve 162. For example, tool 80 may be advanced distally, and be at least in part guided and/or passively steered by sleeve 162 (e.g., tubular longitudinal member 116 may bend to conform with the direction of the sleeve). Such steering may be supplemented by rotation of tool 80.
While arms 92 of tool 80 are in the extended position, the gap between distal portions 94 of each arm (e.g., width d6;
Imaging techniques such as fluoroscopy and/or ultrasound may be used to facilitate the use of tool 80. For example, the position of arms 92 (including the rotational position) with respect to eyelet 46 may be observed using such imaging techniques, and adjusted accordingly. For some applications, fluoroscopy is used, following movement of arms 92 into the intermediate position, to identify successful coupling (e.g., articulatable coupling) of the arms to eyelet 46, such as by identifying the links-in-a-chain arrangement described hereinabove. Similarly, imaging may be used to confirm that another element, such as sleeve 162, has not been engaged by tool 80. Following identification of the links-in-a-chain arrangement, the operating physician may then move the arms into the retracted position. For some applications, radiopaque markings are provided on arms 92, eyelet 46, and/or other components of the apparatus. For example, some elements of the apparatus may comprise tantalum, gold, platinum, or another radiopaque material. For some applications, mechanical guidance, such as that provided by sleeve 162 (as described hereinabove) is used to facilitate advancing of tool 80 (e.g., a distal end thereof) to the vicinity of the anchor, and imaging is used (e.g., only) to facilitate fine manipulation of the tool in order to couple the tool to the anchor.
Throughout the present application various dimensions are mentioned, and the values thereof are typically described with respect to the values of other such dimensions. While not intending to unduly limit the scope of the invention, the following values, which have been determined to be of particular interest to the inventors, are provided:
For some applications, height d1 of eyelet 46 is greater than 1.5 mm and/or less than 7 mm, e.g., greater than 2 mm and/or less than 5 mm, such as greater than 2.3 mm and/or less than 2.6 mm (e.g., between 2.3 mm and 2.6 mm).
For some applications, width d2 of eyelet 46 is greater than 1.5 mm and/or less than 4 mm, e.g., greater than 2 mm and/or less than 3 mm, such as greater than 2.3 mm and/or less than 2.5 mm (e.g., between 2.3 mm and 2.5 mm).
For some applications, thickness d3 of bar 44 is greater than 0.15 mm and/or less than 1.5 mm, e.g., greater than 0.2 mm and/or less than 1 mm, such as greater than 0.25 mm and/or less than 0.4 mm (e.g., between 0.25 mm and 0.4 mm).
For some applications, transverse width d4 of compartment 86 is greater than 1.2 mm and/or less than 3.5 mm, e.g., greater than 1.5 mm and/or less than 2.6 mm, such as greater than 2 mm and/or less than 2.4 mm (e.g., between 2 mm and 2.4 mm).
For some applications, distance d5 between protrusions 90 is greater than 0.8 mm and/or less than 3 mm, e.g., greater than 1 mm and/or less than 2.2 mm, such as greater than 1.5 mm and/or less than 2 mm (e.g., between 1.5 mm and 2 mm).
For some applications, width d6 of the gap between distal portions 94 of arms 92 is greater than 2 mm and/or less than 9 mm, e.g., greater than 3 mm and/or less than 8 mm, such as greater than 5 mm and/or less than 7 mm (e.g., between 5 mm and 7 mm).
For some applications, thickness d7 of arms 92 is greater than 0.15 mm and/or less than 1.2 mm, e.g., greater than 0.2 mm and/or less than 0.8 mm, such as greater than 0.3 mm and/or less than 0.5 mm (e.g., between 0.3 mm and 0.5 mm).
For some applications, width d8 of the area defined by aperture 97 is greater than 1 mm and/or less than 3.5 mm, e.g., greater than 1.5 mm and/or less than 2.6 mm, such as greater than 2 mm and/or less than 2.4 mm (e.g., between 2 mm and 2.4 mm).
For some applications, width d9 of lumen 164 of sleeve 162 is greater than 1.8 mm and/or less than 9 mm, e.g., greater than 2.1 mm and/or less than 6 mm, such as greater than 2.5 mm and/or less than 4 mm (e.g., between 2.5 mm and 4 mm).
Reference is made to
Tool 380 comprises a housing 382 that has an inner surface 384 that defines a generally cylindrical compartment 386 that has a transverse width (e.g., a diameter), as shown in
Tool 380 further comprises an anchor-engaging element 391 comprising at least one curved arm 392. Typically, arm 392 is shaped to define a distal hook portion 394 which, for some applications is helical. Arm 392 is rotatable, independently of housing 382, around a longitudinal axis a6 of the housing (or of tool 380) by rotating a longitudinal member 383 that extends from the arm out of the body of the subject. Arm 392 is also slidable, independently of housing 382, along axis a6 such that the arm (e.g., hook portion 394 thereof) is slidable into and out of the housing.
Tool 380 further comprises an extracorporeal controller (not shown), which comprises a handle and an adjuster, such as a switch or a lever, coupled to housing 382 via a tubular longitudinal member 393. For some applications, the controller of tool 380 is similar to, or comprises, controller 110 described hereinabove with reference to tool 80. The adjuster is configured to move arm 392 between the extended and retracted states. As described for tool 80 (e.g., with reference to
Arm 392 is rotated around axis a6, typically while housing 382 does not rotate. Hook portion 394 hooks through eyelet 46 of anchor 40, preliminarily coupling tool 380 to the anchor (
For some applications of the invention, tool 380 (e.g., the extracorporeal controller thereof) is configured to detect resistance to rotation of arm 392, and in response thereto, to provide an indication of this resistance, and/or to stop rotation of the arm. Typically, such resistance is due to successful hooking of eyelet 46, and the indication and/or stopping of rotation may indicate to the operator to continue with the subsequent steps of the procedure. Alternatively, such resistance may be due to engagement of an undesirable structure, such as tissue of the subject or part of an implant, in which case the indication and/or stopping of rotation may indicate to the operator to reverse the rotation and/or to reposition arm 392.
It is to be noted that tool 380 is shown having been advanced toward, and coupled to eyelet 46 with a longitudinal axis a6 of the tool (e.g., of housing 82) at a nonzero angle of attack with respect to longitudinal axis a1 of anchor 40. Tool 380 is configured to engage (e.g., to be coupled to) eyelet 46 at a variety of angles of attack, including deflection in a plane defined by longitudinal axis a1 of the tissue anchor, and around axis a1, e.g., as described for tool 80 with reference to
For example, tool 380 may be coupled to eyelet 46 while axis a6 is generally parallel to tissue 10, perpendicular to the tissue, or at any angle of attack therebetween. That is, tool 380 is configured to engage the coupling eyelet at at least 180 degrees of deflection of longitudinal axis a6 with respect to longitudinal axis a1 (e.g., in a plane on which axis a1 lies). Similarly, tool 380 may be coupled to eyelet 46 at at least most (e.g., all) rotational angles of attack around longitudinal axis a1, e.g., at at least 300 degrees of deflection of axis a6 around axis a1. For some applications of the invention, this means that when tool 380 is advanced from a given direction (e.g., due to anatomical and/or other constraints), the tool is couplable to eyelet 46 at at least most (e.g., all) rotational angles of attack of anchor 40 around its longitudinal axis.
The above possible angles of attack of tool 380 may also be translated into three-dimensional terms. For example, the possible angles of attack of tool 380 typically, together, define a three-dimensional angular span of at least 1 steradian (e.g., at least 3 steradians, such as at least 7 steradians) around eyelet 46.
While tool 380 is articulatably coupled to anchor 40, the tool is deflectable with respect to the anchor. Typically, in this state, tool 380 is deflectable into any of the angles described hereinabove as angles of attack.
For some applications, such as when an angle between axes a1 and a6 is relatively large, tool 380 is subsequently manipulated so as to reduce the angle between axes a1 and a6, e.g., to at least in part align the tool and anchor 40 (e.g., as described for tool 80 with reference to
Subsequently, arm 392 is moved into the retracted position, typically by housing 382 being slid over the arm (e.g., while the arm remains stationary), and thereby also over at least part of (e.g., most of, or all of) eyelet 46 (
Housing 382 is configured to receive eyelet 46 at a plurality of rotational positions (e.g., a continuum of rotational positions) with respect to the housing, such that portions of bar 44 of eyelet 46 become disposed in a circumferential space between protrusions 390, e.g., as described hereinabove for housing 82, mutatis mutandis.
As described hereinabove, the preliminary coupling of arm 392 to eyelet 46 is an articulatable coupling. Compartment 386 is typically dimensioned such that the eyelet fits generally snugly therewithin. Thereby movement of eyelet 46 into compartment 386 typically inhibits articulation of the eyelet with respect to the arm. The state of tool 380 and anchor 40 shown in
Subsequently, as shown in
It is to be noted that, although
Reference is made to
It is to be noted that tool 480 is shown having been advanced toward, and coupled to eyelet 46 with longitudinal axis a7 of the tool at a nonzero angle of attack with respect to longitudinal axis a1 of anchor 40. Tool 480 is configured to engage (e.g., to be coupled to) eyelet 46 at a variety of angles of attack, including deflection in a plane defined by longitudinal axis a1 of the tissue anchor, and around axis a1, e.g., as described for tool 80 with reference to
For example, tool 480 may be coupled to eyelet 46 while axis a7 is generally parallel to tissue 10, perpendicular to the tissue, or at any angle of attack therebetween. That is, tool 480 is configured to engage the coupling eyelet at at least 180 degrees of deflection of longitudinal axis a7 with respect to longitudinal axis a1 (e.g., in a plane on which axis a1 lies). Similarly, tool 480 may be coupled to eyelet 46 at at least most (e.g., all) rotational angles of attack around longitudinal axis a1, e.g., at at least 300 degrees of deflection of axis a7 around axis a1. For some applications of the invention, this means that when tool 480 is advanced from a given direction (e.g., due to anatomical and/or other constraints), the tool is couplable to eyelet 46 at at least most (e.g., all) rotational angles of attack of anchor 40 around its longitudinal axis.
The above possible angles of attack of tool 480 may also be translated into three-dimensional terms. For example, the possible angles of attack of tool 480 typically, together, define a three-dimensional angular span of at least 1 steradian (e.g., at least 3 steradians, such as at least 7 steradians) around eyelet 46.
While tool 480 is articulatably coupled to anchor 40, the tool is deflectable with respect to the anchor. Typically, in this state, tool 480 is deflectable into any of the angles described hereinabove as angles of attack.
At some point during rotation of tool 480, anchor 40 provides resistance to further rotation of the tool. For example, hook portion 494 may abut base 48 of anchor 40, and/or crest 43 of eyelet 46 of the anchor may abut a mount 482 to which anchor-engaging element 491 is coupled. For some applications of the invention, tool 480 (e.g., the extracorporeal controller thereof) is configured to detect resistance to rotation of anchor-engaging element 491 (e.g., arm 492), and in response thereto, to provide an indication of this resistance, and/or to stop rotation of the arm (e.g., to provide the physician with an opportunity to decide whether to continue rotating the anchor-engaging element).
Once this resistance is met, further rotation of anchor-engaging element 491 (e.g., arm 492) applies a de-anchoring rotational force to eyelet 46, thereby rotating the eyelet and anchor 40 as a whole, and thereby unscrewing the anchor from tissue 10 (
For some applications, such as when an angle between axes a1 and a7 is relatively large, tool 480 is manipulated so as to reduce the angle between axes a1 and a7, e.g., to at least in part align the tool and anchor 40 (e.g., as described for tool 80 with reference to
As described hereinabove, for some applications, distal hook portion 494 has a smaller helix pitch than more proximal portions of the helix of arm 492. Such a configuration is hypothesized to facilitate alignment of tool 480 and anchor 40, by becoming disposed flat against base 48 of the anchor (e.g., as shown in the “optional” bubble of
Reference is made to
Engaging head 502 is configured to be reversibly couplable to tissue anchor 40 (e.g., to the engaging head thereof), so as to facilitate driving of the anchor into tissue of the subject, and subsequent release of the anchor and withdrawal of driver 500 from the subject. Actuation of engaging head 502 by adjuster 508 typically transitions the engaging head between (i) a closed state in which the engaging head is coupled (e.g., locked) to anchor 40, and (ii) an open state in which the engaging head is configured to release the anchor.
Engaging head 502 comprises a casing 514 that defines a slot 520 and a recess 518 and further comprises a detent 510 that is reversibly movable (e.g., deflectable) within the casing, such as being movable into and out of the recess. Typically, (1) detent 510 is biased toward being disposed within recess 518, such as by at least part of the detent (e.g., a stem portion 516) comprising an elastically-deformable material, and (2) the detent is moved out of the recess by a controller, such as a rod 512, applying a force to the detent, such as by being slid by adjuster 508 into at least part of the recess.
Slot 520 is dimensioned to facilitate coupling of driver 500 to anchor 40 by receiving at least part of eyelet 46 of the anchor. For some applications of the invention, driver 500 is provided pre-coupled to anchor 40 (e.g., a kit is provided comprising a plurality of drivers, each driver coupled to a respective anchor). For some applications, driver 500 is coupled to anchor 40 by the operating physician or an assistant thereof.
Movement of detent 510 out of recess 518 transitions engaging head 502 into a closed state thereof in which eyelet 46 is inhibited from exiting slot 520 and therefore in which anchor 40 is coupled to the engaging head. Movement of detent 510 into recess 518 transitions engaging head 502 into an open state thereof in which eyelet 46 is slidable out of slot 520 and thereby in which anchor 40 is decouplable from the engaging head.
Driver 500 is advanced through vasculature of the subject while engaging head 502 is coupled to an anchor 40 as described hereinabove. Driver 500 is advanced toward tissue 10, and the driver (e.g., at least the engaging head thereof) is rotated so as to screw tissue-coupling element 42 of anchor 40 into the tissue (
Driver 500 (e.g., engaging head 502 thereof) typically rotates anchor 40 until base 48 of the anchor is firmly disposed against tissue 10 (
Subsequently, rod 512 is moved out of recess 518 (e.g., by being withdrawn proximally), and detent 510 responsively moves into the recess, thereby transitioning driver 500 (e.g., engaging head 502) into the open state thereof (
For some applications, anchor driver 500 is subsequently discarded, and any additional anchor is delivered and anchored using a respective additional anchor driver. For some applications, additional anchors are delivered and anchored using the same anchor driver.
Reference is made to
Tool 2502 is advanced toward anchor 2532 while anchor-engaging element 2504 is in an open position in which arms 2506 are held away from each other (
Housing 2508 is slid further distally, such that at least part of eyelet 2538 is disposed within the housing (
System 2500 is typically used in a similar manner to that in which system 100 is used. For some applications, system 2500 is used as described for system 100 with reference to
Reference is again made to
For some applications, tool 2502 may be used to redeploy tissue anchor 2532 into tissue. For yet other applications, tool 2502 may be used to initially deploy anchor 2532 into tissue. For example, sleeve 228 and/or sleeve 162 described hereinabove may be preloaded with a plurality of anchors 2532, and tool 2502 may be used to sequentially deploy each anchor into tissue in order to anchor the sleeve to the tissue. For such an application, during the deploying of the plurality of anchors, tool 2502 may also unscrew a given anchor 2532 if the physician determines that the anchor is not positioned correctly.
Typically, but not necessarily, anchor 2532 comprises a biocompatible material such as stainless steel 316 LVM. For some applications, anchor 2532 comprises nitinol. For some applications, anchor 2532 is coated with a non-conductive material.
Reference is now made to
As shown in
Arms 1811 are disposed within an anchor-engaging housing 1804. Housing 1804 is shaped so as to define one or more (e.g., two) slits 1806. Each slit 1806 facilitates movement of at least a portion of each arm 1811 radially away from axis 1807. Housing 1804 is shaped so as to define distal tapered anchor-engaging tip 1808 which is configured to engage an engaging head 1862 of a tissue anchor 1832 (
As shown in
Reference is now made to
As shown in Section B-B, plunger 1820 is coupled at a proximal portion thereof to a plunger-manipulating element 1852. Element 1852 is slidable within a tube 1850, which is coupled at a distal end thereof to respective proximal-most portions 1812 of structures 1810. As indicated by the arrow, element 1852 is advanced distally by sliding within tube 1850, and thereby, element 1852 pushes plunger 1820 distally in a manner in which the proximal portion of force applicator 1821 is pushed beyond proximal portion 1813 of arm 1811 and force applicator 1821 is disposed adjacently to inner surface 1815 of arm 1811 at central curved portion 1814. As shown in
Each hook 1816 moves within a respective slit 1806. As hooks 1816 move, the proximal portion of outer covering 1830 applies a counterforce against structure 1830 to further maintain hooks 1816 in the closed state. Additionally, a distal portion of covering 1830 partially covers slits 1806 and applies additional counterforce against proximal portion 1813 of arm 1811.
Reference is now made to
In such a configuration of hooks 1816 with respect to undercut 1868 in
For yet other applications, tool 1802 may be used to initially deploy anchor 1832 into tissue. For example, sleeve 228 and/or sleeve 162, described hereinabove, may be preloaded with a plurality of anchors 1832, and tool 1802 may be used to sequentially deploy each anchor 1832 into tissue in order to anchor the sleeve to tissue. For such an application, during the deploying of the plurality of anchors, tool 1802 may also unscrew a given anchor 1832 if the physician determines that the anchor is not positioned correctly.
Typically, but not necessarily, anchor 1832 comprises a biocompatible material such as stainless steel 316 LVM. For some applications, anchor 1832 comprises nitinol. For some applications, anchor 1832 is coated with a non-conductive material.
Reference is now made to
System 1800 is typically used in a similar manner to that in which system 100 and/or system 2500 is used. For some applications, system 1800 is used as described for system 100 with reference to
Reference is made to
It is hypothesized that, for some applications, it is advantageous to move tool 80 and anchor 40 through at least some parts of a catheter (e.g., catheter 214) while in the articulatably-coupled state. For example, and as shown in
For some applications, tool 80 may be configured to maintain the tool and anchor 40 in the articulatably-coupled state (e.g., to prevent rigid coupling therebetween). For example, tool 80 may comprise a stopper, configured to prevent eyelet 46 from entering (e.g., fully entering) compartment 86. Alternatively, housing 82 may be configured (e.g., shaped) not to receive eyelet 46 (e.g., the housing may be configured to receive only arms 92 and not eyelet 46).
Reference is again made to
Tool 680 comprises a housing 682 that has an inner surface that defines a generally cylindrical compartment 686 that has an opening 688 at a distal end 683 of the housing. Tool 80 further comprises an anchor-engaging element 691 comprising one or more (e.g., two) arms 692 (e.g., a first arm 692a and a second arm 692b) that define a space 696 therebetween. At least one arm is shaped (e.g., curved) to define a concavity 703. For example, and as shown in
Movement of housing 682 with respect to arms 692 moves the arms between an extended position (
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
The present application is a Continuation of U.S. Ser. No. 14/437,062 to Herman et al., which published as US 2015/0272586, and which is the US National Phase of PCT application IL2013/050861 to Herman et al., filed Oct. 23, 2013, which published as WO 2014/064695, and which claims priority from: U.S. Provisional Patent Application 61/717,303 to Sheps et al., titled “Controlled steering functionality for implant-delivery tool,” filed Oct. 23, 2012;U.S. Provisional Patent Application 61/745,848 to Sheps et al., titled “Controlled steering functionality for implant-delivery tool,” filed Dec. 26, 2012;U.S. Provisional Patent Application 61/784,042 to Herman et al., titled “Percutaneous tissue anchor techniques,” filed Mar. 14, 2013; andU.S. Provisional Patent Application 61/820,979 to Sheps et al., titled “Controlled steering functionality for implant-delivery tool,” filed May 8, 2013, all of which are incorporated herein by reference.
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| Number | Date | Country | |
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| Parent | 14437062 | US | |
| Child | 16427061 | US |
