Diagnostic catheters, guide catheters, visualization devices and chord manipulation devices, and related kits and methods

Described herein are devices, methods and kits for assessing and/or enhancing the accessibility of a subvalvular space of a heart, accessing the subvalvular space of the heart (e.g., to provide access for one or more other devices), and/or positioning one or more devices in the subvalvular space of the heart. The devices described herein may, for example, comprise catheters that may be used to manipulate one or more chordae tendineae, diagnostic catheters having different sizes and/or shapes (e.g., different curvatures), guide catheters having different sizes and/or shapes (e.g., different curvatures), and visualization catheters. In some variations, the devices, methods, and/or kits may be used to visualize a target site, such as a subannular groove of a heart valve. In certain variations, the devices, methods, and/or kits may be used to manipulate chordae tendineae to provide additional space in a ventricle of a heart (e.g., enhancing the accessibility of the ventricle).

DEVICES AND METHODS FOR ANCHORING TISSUE

Anchors, anchoring systems, anchor delivery devices, and method of using anchors are described. An anchor may be a flexible anchor having two curved legs that cross in a single turning direction to form a loop, wherein the legs are adapted to penetrate tissue. The ends of the curved legs may be blunt or sharp. The anchor can assume different configurations such as a deployed configuration and a delivery configuration, and the anchor may switch between these different configurations. In operation, the anchor may be inserted into tissue by releasing the anchor from a delivery configuration so that the anchor self-expands into the deployed configuration, so that the legs of the anchor may penetrate the tissue in a curved pathway. 1. An anchor device comprising:a catheter; anda self-securing anchor coupled to a tether, the anchor having an initial constrained undeployed configuration wherein the anchor is constrained by the catheter, and a deployed configuration wherein the anchor is released from the catheter, wherein the anchor has two legs having ends and wherein the legs of the anchor in both the initial undeployed and the deployed configurations cross in a single turning direction from one end to the other end to form a loop, the loop defining an opening that shortens as the anchor changes from the initial undeployed configuration to the deployed configuration, and wherein the leg ends in the deployed configuration curve back toward the loop.2. The anchor of wherein the ends of the legs are blunt.3. The anchor of claim 1 , wherein the ends of the legs are sharp.4. The anchor of claim 1 , wherein the anchor is made of a shape-memory material.5. The anchor of claim 4 , wherein the anchor comprises Nickel-Titanium Alloy.6. The anchor of claim 1 , wherein the anchor is made of a superelastic material.7. The anchor of claim 1 , wherein the legs are collapsed in the undeployed configuration and expanded in the deployed configuration.8. The anchor of claim 1 , wherein ...

TETHER-ANCHOR ASSEMBLIES

Anchors, tethers, knot configurations and other coupling mechanisms used to secure tethers to anchors or other implants are described. The knot configurations described may provide enhanced knot security and/or tensile strength, while also occupying relatively little volume. In some variations, the surfaces of a tether and/or an anchor or other implant may be at least partially coated with one or more agents and/or may be at least partially textured.

DEFLECTABLE GUIDE

Described herein are devices and methods for guide catheters having one or more regions of increased flexibility. A flexibility region comprises one tubular segment of the guide catheter with a non-linear longitudinal seam between two non-concentric layers of material having different durometers. A non-linear seam, such as a zig-zag or sinusoidal configuration, permits controlled compression of lower durometer material between portions of higher durometer material. 115-. (canceled)16. A method for treating a patient , comprising:providing a catheter having a lower durometer region comprising at least one compressible portion and a greater durometer region comprising at least two constricting portions in an alternating configuration with the last least one compressible portion;bending the catheter such that the at least two constricting portions of the higher durometer region compresses the at least one compressible portion of the lower durometer region; andpassing a tubular body down a passageway of the catheter.17. A system for treating a patient , comprising:a guide catheter comprising a longitudinal axis, a guide lumen, and at least one deformation zone, the at least one deformation zone comprising two segments of polymeric material of different durometers and a longitudinal interface therebetween with respect to the longitudinal axis of the guide catheter;a tunnel catheter comprising a tubular body with a tunnel lumen, wherein the tubular body is configured for insertion into the guide lumen of the guide catheter; anda delivery catheter comprising an anchor retaining cavity and an anchor delivery mechanism, wherein the delivery catheter is configured for insertion into the tunnel lumen of the tunnel catheter.18. The system of claim 17 , wherein the tubular body of the tunnel catheter further comprises a plurality of delivery apertures in communication with the tunnel lumen.19. The system of claim 17 , wherein the longitudinal configuration between the two ...

Deflectable guide

Described herein are devices and methods for guide catheters having one or more regions of increased flexibility. A flexibility region comprises one tubular segment of the guide catheter with a non-linear longitudinal seam between two non-concentric layers of material having different durometers. A non-linear seam, such as a zig-zag or sinusoidal configuration, permits controlled compression of lower durometer material between portions of higher durometer material.

MULTI-WINDOW GUIDE TUNNEL

Described herein are devices and methods for delivering implants that comprise multiple coupled anchors. The anchors are secured to tissue using a multi-opening guide tunnel that is configured to releasably retain one or more portions of the implant located between two of the anchors. The releasable retention of one or more intervening portions of the implant maintains the position of the implant and the guide tunnel until the implant is secured to the tissue. The multi-opening guide tunnel permits securement of the multiple anchors without requiring repositioning of the guide tunnel for each anchor.

DEVICES AND METHODS FOR TERMINATION

Devices and methods for locking and/or cutting tethers during a tissue modification procedure are described. In some variations, a tether may be used to tighten or compress tissue by bringing two pieces or sections of the tissue together. The tether, which may be under tension, may be locked to maintain the tension, and excess tether may be severed, using one or more of the devices and/or methods. The devices and/or methods may be used, for example, in minimally invasive procedures.

Devices and methods for cardiac annulus stabilization and treatment

Devices and methods generally provide enhanced stabilization, exposure and/or treatment of a cardiac valve annulus. Methods generally involve introducing a stabilizing member beneath one or more leaflets of a heart valve to engage the annulus at an intersection between the leaflets and the interior ventricular wall of the heart. Force is then applied to the stabilizing member to stabilize and/or expose the valve annulus. In some embodiments, the stabilizing member may include a series of hydraulically driven tethered anchors, such as hooks or clips, for engaging and cinching valve annulus tissue to decrease the diameter of a regurgitant valve. Alternatively, other treatments may be delivered by a stabilizing member, such as radiofrequency energy, drugs, bulking agents or shape memory stents. A second stabilizing member may also be introduced above the leaflets for further stabilization.

METHODS AND DEVICES FOR TERMINATION

Devices and methods used in termination of a tissue tightening procedure are described. Termination includes the cinching of a tether to tighten the tissue, locking the tether to maintain tension, and cutting excess tether. In procedures involving anchors secured to the tissue, the tether is coupled to the anchors and the tissue is tightened via tension applied to the anchors by cinching the tether. In general, the devices and methods can be used in minimally invasive surgical procedures, and can be applied through small incisions or intravascularly. A method for tightening tissue by fixedly coupling a first anchor to a tether and slidably coupling a second anchor to the tether, securing both anchors to the tissue, applying tension to the tether intravascularly, fixedly coupling the tether to the second anchor, and cutting the tether is described. The tissue to be tightened can comprise heart tissue, in particular heart valve annulus tissue. Various devices and methods for locking the tether ...

DEVICES AND METHODS FOR ANCHORING TISSUE

Described herein are devices and methods for delivering implants that comprise multiple coupled anchors. The anchors have an elongate form following a curved arcuate path in a single turning direction. Each anchor has two legs arranged to diverge away from each other, where each leg has a substantially non-constant radius of curvature and a substantially straight distal tip. The anchors are secured to tissue using a multi-opening guide tunnel that is configured to releasably retain one or more portions of the implant located between two of the anchors. The releasable retention of one or more intervening portions of the implant maintains the position of the implant and the guide tunnel until the implant is secured to the tissue. One variation of a multi-opening guide tunnel comprises releasable retention flaps and an aperture capable of deploying a fluid contrast medium into a patient without interfering with anchor delivery. 1. An anchor for securing a tether to human tissue , the anchor comprising:a shape memory wire body having an unconstrained curved elongate form with a single loop, the elongate form substantially following a curved arcuate path in a single turning direction, the anchor having two legs arranged to substantially diverge away from each other, wherein each leg comprises a substantially non-constant radius of curvature and a substantially straight distal tip.2. The anchor of claim 1 , wherein the anchor is made of a nickel titanium alloy.34-. (canceled) This application claims the benefit of U.S. Provisional Application No. 61/380,182, filed Sep. 3, 2010, the disclosure of which is hereby incorporated by reference in its entirety.Blood returning to the heart from the peripheral circulation and the lungs generally flows into the atrial chambers of the heart and then to the ventricular chambers, which pump the blood back out of the heart. During ventricular contraction, the atrio-ventricular valves between the atria and ventricles, i.e. the tricuspid ...

Methods and devices for termination

Devices and methods used in termination of a tissue tightening procedure are described. Termination includes the cinching of a tether to tighten the tissue, locking the tether to maintain tension, and cutting excess tether. In procedures involving anchors secured to the tissue, the tether is coupled to the anchors and the tissue is tightened via tension applied to the anchors by cinching the tether. In general, the devices and methods can be used in minimally invasive surgical procedures, and can be applied through small incisions or intravascularly. A method for tightening tissue by fixedly coupling a first anchor to a tether and slidably coupling a second anchor to the tether, securing both anchors to the tissue, applying tension to the tether intravascularly, fixedly coupling the tether to the second anchor, and cutting the tether is described. The tissue to be tightened can comprise heart tissue, in particular heart valve annulus tissue. Various devices and methods for locking the tether in place and cutting excess tether are described.

Methods and devices for termination

Devices and methods used in termination of a tissue tightening procedure are described. Termination includes the cinching of a tether to tighten the tissue, locking the tether to maintain tension, and cutting excess tether. In procedures involving anchors secured to the tissue, the tether is coupled to the anchors and the tissue is tightened via tension applied to the anchors by cinching the tether. In general, the devices and methods can be used in minimally invasive surgical procedures, and can be applied through small incisions or intravascularly. A method for tightening tissue by fixedly coupling a first anchor to a tether and slidably coupling a second anchor to the tether, securing both anchors to the tissue, applying tension to the tether intravascularly, fixedly coupling the tether to the second anchor, and cutting the tether is described. The tissue to be tightened can comprise heart tissue, in particular heart valve annulus tissue. Various devices and methods for locking the tether ...

DEVICES, METHODS, AND KITS FOR GASTROINTESTINAL PROCEDURES

Devices, methods and kits for restricting a portion of a GI tract by tightening tissue are provided. The devices, methods and kits can be used to treat GERD or obesity. The devices, methods, and kits do not require the formation of plications in tissue walls and may result in faster application, reduced surgical trauma, reduced risk, and reduced cost. The devices comprise a plurality of tissue-engageable anchors coupled to a tether. Each anchor is secured to a tissue wall of the GI tract. The anchors are secured to the tissue wall in a manner that may minimize tissue damage. The tether is configured to be cinched to draw the anchors together, which in turn draws the tissue secured to the anchors together, thereby tightening tissue to restrict a portion of the GI tract.

Methods and devices for termination

Devices and methods used in termination of a tissue tightening procedure are described. Termination includes the cinching of a tether to tighten the tissue, locking the tether to maintain tension, and cutting excess tether. In procedures involving anchors secured to the tissue, the tether is coupled to the anchors and the tissue is tightened via tension applied to the anchors by cinching the tether. In general, the devices and methods can be used in minimally invasive surgical procedures, and can be applied through small incisions or intravascularly. A method for tightening tissue by fixedly coupling a first anchor to a tether and slidably coupling a second anchor to the tether, securing both anchors to the tissue, applying tension to the tether intravascularly, fixedly coupling the tether to the second anchor, and cutting the tether is described. The tissue to be tightened can comprise heart tissue, in particular heart valve annulus tissue. Various devices and methods for locking the tether ...

Methods for remodeling cardiac tissue

Described herein are methods of remodeling the base of a ventricle. In particular, methods of remodeling a valve annulus by forming a new fibrous annulus are described. These methods may result in a remodeled annulus that corrects valve leaflet function without substantially inhibiting the mobility of the leaflet. The methods of remodeling the base of the ventricle include the steps of securing a plurality of anchors to the valve annulus beneath one or more leaflets of the valve, constricting the valve annulus by cinching a tether connecting the anchors, and securing the anchors in the cinched conformation to allow the growth of fibrous tissue. The annulus may be cinched (e.g., while visualizing the annulus) so that the mobility of the valve leaflets is not significantly restricted. The remodeled annulus is typically constricted to shorten the diameter of the annulus to correct for valve dysfunction (e.g., regurgitation).

Devices and methods for heart valve repair

Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

IMPLANT RETRIEVAL DEVICE

Devices and methods are disclosed for retrieving an implant or tissue anchor during the course of a percutaneous medical procedure. An implant is provided having a retrieval tether attached to it. The retrieval tether is attached to the implant on one end, and the proximal end of the tether can be threaded through an implant retrieval device. The retrieval device comprises an inner elongate body that is used to capture and secure the retrieval tether. The retrieval device also comprises an outer elongate body that may be configured to be advanced over the retrieval tether from a location remote from the implant (e.g., outside a patient's body) to contact and retrieve the implant after it has been deployed and/or implanted within a patient's body. 1. An implant retrieval device comprising:an outer elongate body having a first longitudinal lumen extending therethrough;an inner elongate body within the first longitudinal lumen, wherein the inner elongate body comprises a second longitudinal lumen and a stop located within the second longitudinal lumen at a distal portion thereof;an actuator slidably coupled to the inner elongate body; anda retrieval cable slidably disposed within the second longitudinal lumen of the inner elongate body and connected to the actuator such that the retrieval cable at least partially surrounds the stop.2. The implant retrieval device of claim 1 , wherein the proximal ends of the retrieval cable are attached to the actuator.3. The implant retrieval device of claim 1 , wherein the outer elongate body comprises a first pre-shaped curve with a first radius of curvature and a second pre-shaped curve located distal to the first pre-shaped curve claim 1 , wherein the second pre-shaped curve has a second radius of curvature that is less than the first radius of curvature.4. The implant retrieval device of claim 3 , wherein the first radius of curvature is about 1.25 inches and the second radius of curvature is about 0.17 inch.5. The implant ...

Delivery devices and methods for heart valve repair

Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

DEFLECTABLE GUIDE

Described herein are devices and methods for guide catheters having one or more regions of increased flexibility. A flexibility region comprises one tubular segment of the guide catheter with a non-linear longitudinal seam between two non-concentric layers of material having different durometers. A non-linear seam, such as a zig-zag or sinusoidal configuration, permits controlled compression of lower durometer material between portions of higher durometer material.

Tether tensioning devices and related methods

Devices, methods, and kits for tensioning tethers during a tissue modification procedure are described. In some variations, a tether coupled to anchors embedded in tissue may be tensioned to provide a cinching effect that tightens or compresses the tissue by bringing two pieces or sections of the tissue together. In certain variations, the tether may then be locked (e.g., to maintain the tension), and/or excess tether may be severed. The devices, methods, and/or kits may be used, for example, in minimally invasive procedures.

ELECTROPHYSIOLOGY CATHETER SYSTEM

Described herein are devices and methods for treating tissue, comprising a catheter with a plurality of access sites and a plurality of sensors associated with the access sites. The catheter may be positioned along a tissue surface and the sensors may be used to identify a target site along the tissue surface using the plurality of sensors. Analysis of the tissue surface by the sensors is performed without requiring repositioning of the catheter. In some examples, the access sites of the catheter are side openings along a length of the catheter and the plurality of sensors are electrodes configured to measure electrophysiology parameters. In these examples, the catheter may comprise an internal lumen which permits a treatment device, such as an ablation catheter, to be slidably positioned at the desired target site without requiring displacement of the catheter. In other examples, the catheter may comprise a plurality of fixed ablation elements associated with the plurality of access sites ...

MULTI-WINDOW GUIDE TUNNEL

Described herein are devices and methods for delivering implants that comprise multiple coupled anchors. The anchors are secured to tissue using a multi-opening guide tunnel that is configured to releasably retain one or more portions of the implant located between two of the anchors. The releasable retention of one or more intervening portions of the implant maintains the position of the implant and the guide tunnel until the implant is secured to the tissue. The multi-opening guide tunnel permits securement of the multiple anchors without requiring repositioning of the guide tunnel for each anchor.

SYSTEMS AND METHODS FOR VARIABLE STIFFNESS TETHERS

Described herein are devices and methods for guide elements configured with variable stiffness, with one or more flexible portions and one or more stiff portions. The flexible portion is be used as a tensioning element of a cinchable implant to tighten or compress tissues while the stiff portion is used to facilitate the insertion or withdrawal of portions of the implant or instruments acting on the implant. The guide element is further configured to be separated or severed between the flexible and stiff portions so that a flexible portion is left within the body as part of the implant, while the stiff portion is withdrawn from the body after implantation is completed. 1. A guidewire element comprising:a rigid proximal portion;a flexible distal portion;an attachment portion configured to releasably attach the flexible distal portion to the rigid proximal portion; andwherein the flexible distal portion is configured to be used as a tensioning element.2. The guidewire element of claim 1 , wherein the flexible portion has a first torsional stiffness and the rigid portion has a second torsional stiffness that is higher than the first torsional stiffness.3. The guidewire element of claim 1 , wherein the force required to cause the rigid portion to yield in a compression test is greater than the force required to cause the flexible portion to yield in a compression test.4. The guidewire element of claim 1 , wherein the proximal portion comprises a first portion and a second portion claim 1 , wherein the first portion is more rigid than the second portion.5. The guidewire element of claim 1 , wherein the attachment portion comprises a first clasp attached to the rigid proximal portion claim 1 , a second clasp that interfits with the first clasp attached to the flexible distal portion claim 1 , and a pull-wire slidably insertable within the first and second clasps claim 1 , wherein in a first protracted configuration the pull-wire secures the engagement between the first ...

DIAGNOSTIC CATHETERS, GUIDE CATHETERS, VISUALIZATION DEVICES AND CHORD MANIPULATION DEVICES, AND RELATED KITS AND METHODS

Described herein are devices, methods and kits for assessing and/or enhancing the accessibility of a subvalvular space of a heart, accessing the subvalvular space of the heart (e.g., to provide access for one or more other devices), and/or positioning one or more devices in the subvalvular space of the heart. The devices described herein may, for example, comprise catheters that may be used to manipulate one or more chordae tendineae, diagnostic catheters having different sizes and/or shapes (e.g., different curvatures), guide catheters having different sizes and/or shapes (e.g., different curvatures), and visualization catheters. In some variations, the devices, methods, and/or kits may be used to visualize a target site, such as a subannular groove of a heart valve. In certain variations, the devices, methods, and/or kits may be used to manipulate chordae tendineae to provide additional space in a ventricle of a heart (e.g., enhancing the accessibility of the ventricle). 125-. (canceled)26. A method of accessing a subannular groove of a heart comprising:loading a first guidewire into a first catheter;advancing the first guidewire and the first catheter across an aortic valve and into a ventricle;withdrawing the first guidewire from the first catheter;delivering a contrast agent through the first catheter and visualizing the subannular groove;advancing a second guidewire through the first catheter and around at least a portion of a subannular groove region; andverifying positioning of the second guidewire.27. The method of wherein the first guidewire and the second guidewire are the same guidewire.28. The method of wherein the first catheter comprises a proximal end claim 26 , a distal end claim 26 , and a lumen therethrough claim 26 , and further comprising a first curve region defining a first plane claim 26 , a second curve region defining a second plane claim 26 , and a third curve region defining a third plane claim 26 ,wherein a first angle between the first ...

DEVICES AND METHODS FOR TERMINATION

Devices and methods for locking and/or cutting tethers during a tissue modification procedure are described. In some variations, a tether may be used to tighten or compress tissue by bringing two pieces or sections of the tissue together. The tether, which may be under tension, may be locked to maintain the tension, and excess tether may be severed, using one or more of the devices and/or methods. The devices and/or methods may be used, for example, in minimally invasive procedures. 1. A device comprising:an elongated member comprising a wall portion and a lumen defined by the wall portion; anda semitubular or tubular cutter disposed within the lumen and having a proximal end and a distal end, wherein the proximal end has a sharpened cutting edge,wherein the wall portion comprises first and second separate openings positioned such that a tether, when extended therethrough, crosses the lumen, and wherein the cutter is configured to cut a first portion of the tether without simultaneously cutting a second portion of the tether.2. The device of claim 1 , wherein the cutter is tubular.3. The device of claim 1 , wherein the first and second openings are positioned such that a tether claim 1 , when extended therethrough claim 1 , forms a substantially diagonal path across the lumen of the elongated member.4. The device of claim 1 , wherein the elongated member comprises a catheter.5. The device of claim 1 , further comprising a locking element configured to secure a tether.6. The device of claim 5 , wherein the elongated member has a proximal portion and a distal portion claim 5 , and the locking element is releasably coupled to the distal portion of the elongated member.7. The device of claim 5 , wherein the locking element comprises a plug and a locking tube configured to receive the plug.8. The device of claim 1 , further comprising pulling member attached to the semitubular or tubular cutter.9. A method comprising:advancing a tether into a locking element;tensioning ...

ANCHOR DEPLOYMENT DEVICES AND RELATED METHODS

Described here are devices, methods, and kits for the deployment of tissue anchors. In some variations, the devices may comprise a shaft defining a lumen for housing at least one anchor therein and a mechanism for deploying the anchor distally from the lumen. In certain variations, the devices may comprise one or more stop elements. For example, a device may comprise a stop element that limits the advancement of the device through an opening in a wall portion or at the distal end of another device. 110-. (canceled)11. A catheter comprising:a tubular elongated member defining a proximal portion, a distal portion, and a lumen therethrough; anda first stop element comprising an elongated flap,wherein a first portion of the first stop element is disposed within the lumen of the tubular elongated member, and a second portion of the first stop element extends through an opening in a wall portion of the tubular elongated member.12. The catheter of claim 11 , further comprising an anchor disposed within the lumen of the tubular elongated member.13. The catheter of claim 12 , further comprising a coupling member coupled to the anchor.14. The catheter of claim 11 , further comprising a second stop element disposed within the lumen of the tubular elongated member.15. The catheter of claim 14 , wherein the second stop element comprises a tubular member.16. The catheter of claim 14 , wherein the second stop element is coupled to or integral with the first stop element.17. The catheter of claim 14 , wherein the second stop element is separate from the first stop element.18. The catheter of claim 14 , further comprising a pushing member including a distal portion comprising a first region having a first cross-sectional diameter and a second region having a second cross-sectional diameter that is smaller than the first cross-sectional diameter.19. The catheter of claim 11 , wherein the tubular elongated member comprises a first region defining a first plane claim 11 , a second ...

TERMINATION DEVICES AND RELATED METHODS

Devices and methods for locking and/or cutting tethers during a tissue modification procedure are described. In some variations, a tether may be used to tighten tissue by bringing two pieces or sections of the tissue together. The tether, which may be under tension, may be locked to maintain the tension, and excess tether may be severed, using one or more of the devices and/or methods. The devices and/or methods may be used, for example, in minimally invasive procedures. 1. A device for securing a tether comprising:a locking member configured to receive a plug and comprising a proximal end, a distal end, and a lumen therethrough; anda plug rotatable within the lumen of the locking member to secure a portion of a tether within the lumen, the plug comprising an exterior surface and at least one protrusion configured to engage a portion of a tether within the lumen of the locking member between the at least one protrusion and locking member to secure the tether,wherein the locking member comprises a wall portion comprising an interior surface, and wherein the exterior surface of the plug has at least one contour alignable with the interior surface of the wall portion when the plug is at least partially disposed within the lumen of the locking member.2. The device of claim 1 , further comprising an elongated member comprising a distal portion to which the locking member is releasably coupled.3. The device of claim 1 , wherein the wall portion of the locking member comprises first and second apertures alignable for passage of a tether therethrough.4. The device of claim 3 , wherein the first and second apertures are located such that a tether passing therethrough would not cross the center of the lumen of the locking member.5. The device of claim 1 , wherein the locking member comprises a tubular member.6. The device of claim 1 , wherein the plug is rotatable by at least about 1° to secure a portion of a tether within the lumen of the locking member.7. The device of ...

DEVICES AND METHODS FOR HEART VALVE REPAIR

Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device. 1117-. (canceled)118. A method of constricting tissue in a heart , the method comprising:advancing an operational device such that a distal end of the operational device is entirely within a ventricle to contact a length of ventricular tissue located between a left ventricular wall, at least one mitral valve leaflet and at least one chordae tendineae of the heart, wherein the operational device comprises a lumen and a plurality of apertures in communication with the lumen for delivering a plurality of anchors therethrough, wherein contacting the length of tissue comprises simultaneously positioning the plurality of coupled anchors along the length of the tissue; delivering the simultaneously positioned plurality of coupled anchors from the lumen of device through the plurality of apertures to secure the anchors to the tissue; and drawing the anchors together to constrict the tissue.119. A method as in claim 118 , wherein contacting claim 118 , delivering and drawing are performed as part of an open heart surgical ...

Methods and devices for termination

Devices and methods used in termination of a tissue tightening procedure are described. Termination includes the cinching of a tether to tighten the tissue, locking the tether to maintain tension, and cutting excess tether. In procedures involving anchors secured to the tissue, the tether is coupled to the anchors and the tissue is tightened via tension applied to the anchors by cinching the tether. In general, the devices and methods can be used in minimally invasive surgical procedures, and can be applied through small incisions or intravascularly. A method for tightening tissue by fixedly coupling a first anchor to a tether and slidably coupling a second anchor to the tether, securing both anchors to the tissue, applying tension to the tether intravascularly, fixedly coupling the tether to the second anchor, and cutting the tether is described. The tissue to be tightened can comprise heart tissue, in particular heart valve annulus tissue. Various devices and methods for locking the tether in place and cutting excess tether are described.

Devices and methods for heart valve repair

Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

Multi-window guide tunnel

Described herein are devices and methods for delivering implants that comprise multiple coupled anchors. The anchors are secured to tissue using a multi-opening guide tunnel that is configured to releasably retain one or more portions of the implant located between two of the anchors. The releasable retention of one or more intervening portions of the implant maintains the position of the implant and the guide tunnel until the implant is secured to the tissue. The multi-opening guide tunnel permits securement of the multiple anchors without requiring repositioning of the guide tunnel for each anchor.

Devices and methods of visualizing and determining depth of penetration in cardiac tissue

Disclosed herein are devices and methods for assessing the surface of a target cardiac tissue and for delivering a tissue anchor to cardiac tissue at a preselected depth within the myocardium in a beating heart procedure. In one variation, an anchor delivery device comprises an elongate body, a tissue anchor disposed within a first longitudinal lumen of the elongate body, and a tissue depth indicator slidable within a second longitudinal lumen of the elongate body. The tissue depth indicator has a first configuration that indicates the boundary of the surface of the target tissue and a second configuration that indicates when the distal tip of the elongate body has been advanced to a preselected depth into the target tissue. In some variations, a tissue depth indicator may also be configured to resist or limit the penetration of the delivery device into tissue after a preselected depth has been reached.

Delivery devices and methods for heart valve repair

Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Delivery devices and methods for heart valve repair

Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Delivery devices and methods for heart valve repair

Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Methods and devices for termination

Devices and methods for heart valve repair

Methods and devices provide constriction of a heart valve annulus to treat cardiac valve regurgitation and other conditions. Embodiments typically include a device for attaching a cinching or tightening apparatus to a heart valve annulus to reduce the circumference of the annulus, thus reducing valve regurgitation. Tightening devices may include multiple tethered clips, multiple untethered crimping clips, stabilizing devices, visualization devices, and the like. In one embodiment, a plurality of tethered clips is secured circumferentially to a valve annulus, and the tether coupling the clips is cinched to reduce the circumference of at least a portion of the annulus. Methods and devices may be used in open heart surgical procedures, minimally invasive procedures, catheter-based procedures, and/or procedures on beating hearts or stopped hearts.

Multi-window guide tunnel

Tether tensioning devices and related methods

Devices, methods, and kits for tensioning tethers during a tissue modification procedure are described. In some variations, a tether coupled to anchors embedded in tissue may be tensioned to provide a cinching effect that tightens or compresses the tissue by bringing two pieces or sections of the tissue together. In certain variations, the tether may then be locked (e.g., to maintain the tension), and/or excess tether may be severed. The devices, methods, and/or kits may be used, for example, in minimally invasive procedures.

Delivery devices and methods for heart valve repair

Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Delivery devices and methods for heart valve repair

Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Catheter for implant deployment

A catheter with an elongated body having a lumen and a slot and an aperture. There is also an implant with an eyelet, as well as a tether threaded through the slot, the aperture and the eyelet.

Deflectable guide

Described herein are devices and methods for guide catheters having one or more regions of increased flexibility. A flexibili-ty region comprises one tubular segment of the guide catheter with a non-linear longitudinal seam between two non-concentric layers of mate-rial having different durometers. A non-linear seam, such as a zig-zag or sinusoidal configuration, permits controlled compression of lower durometer material between portions of higher durometer material.

Multi-window guide tunnel

Described herein are devices and methods for delivering implants that include multiple coupled anchors. The anchors are secured to tissue using a multi-opening guide tunnel that is configured to releasably retain one or more portions of the implant located between two of the anchors. The releasable retention of one or more intervening portions of the implant maintains the position of the implant and the guide tunnel until the implant is secured to the tissue. The multi-opening guide tunnel permits securement of the multiple anchors without requiring repositioning of the guide tunnel for each anchor.

Implant retrieval device

Devices and methods are disclosed for retrieving an implant or tissue anchor during the course of a percutaneous medical procedure. An implant is provided having a retrieval tether attached to it. The retrieval tether is attached to the implant on one end, and the proximal end of the tether can be threaded through an implant retrieval device. The retrieval device comprises an inner elongate body that is used to capture and secure the retrieval tether. The retrieval device also comprises an outer elongate body that may be configured to be advanced over the retrieval tether from a location remote from the implant (e.g., outside a patient's body) to contact and retrieve the implant after it has been deployed and/or implanted within a patient' s body.

Methods and devices for catheter advancement and delivery of substances therethrough

Methods and devices for successively advancing a plurality of catheters over a guide element to a body tissue are described. In some of the methods, the guide element may be attached to the body tissue, which may be accessible minimally invasively. In certain variations, the guide element may not be detached from the body tissue after the catheters have been advanced over the guide element. The methods may further comprise deploying at least one implant from at least one of the plurality of catheters. In some variations, a method may comprise advancing a first delivery catheter to a first region of body tissue, deploying a first anchor from the first delivery catheter, where the first anchor is attached to a guide element, proximally withdrawing the first delivery catheter, advancing a second delivery catheter over the guide element, and deploying a second anchor from the second delivery catheter. 420 FIG. 4G 420 422 FIG. 4H 420 42 FIG. 41

Devices and methods for heart valve repair

Methods and devices provide constriction of a heart valve annulus to treat cardiac valve regurgitation and other conditions. Embodiments typically include a device for attaching a cinching or tightening apparatus to a heart valve annulus to reduce the circumference of the annulus, thus reducing valve regurgitation. Tightening devices may include multiple tethered clips, multiple untethered crimping clips, stabilizing devices, visualization devices, and the like. In one embodiment, a plurality of tethered clips is secured circumferentially to a valve annulus, and the tether coupling the clips is cinched to reduce the circumference of at least a portion of the annulus. Methods and devices may be used in open heart surgical procedures, minimally invasive procedures, catheter-based procedures, and/or procedures on beating hearts or stopped hearts.

Devices and methods for cardiac annulus stabilization and treatment

Devices and methods generally provide enhanced stabilization, exposure and/or treatment of a cardiac valve annulus. Methods generally involve introducing a stabilizing member beneath one or more leaflets of a heart valve to engage the annulus at an intersection between the leaflets and the interior ventricular wall of the heart. Force is then applied to the stabilizing member to stabilize and/or expose the valve annulus. In some embodiments, the stabilizing member may include a series of hydraulically driven tethered anchors, such as hooks or clips, for engaging and cinching valve annulus tissue to decrease the diameter of a regurgitant valve. Alternatively, other treatments may be delivered by a stabilizing member, such as radiofrequency energy, drugs, bulking agents or shape memory stents. A second stabilizing member may also be introduced above the leaflets for further stabilization.

Tether tensioning devices and related methods

Devices, methods, and kits for tensioning tethers during a tissue modification procedure are described. In some variations, a tether coupled to anchors embedded in tissue may be tensioned to provide a cinching effect that tightens or compress-es the tissue by bringing two pieces or sections of the tissue together. In certain variations, the tether may then be locked (e.g., to maintain the tension), and/or excess tether may be severed. The devices, methods, and/or kits may be used, for example, in mini-mally invasive procedures.

Systems and methods for cardiac remodeling

Described herein are devices and methods for improving the hemodynamic function of a patient. In particular, a first device adapted to reshape an atrio-ventricular valve is used in combination with a second device configured to further alter the blood flow through the valve. The first device is typically an implant positioned in the subvalvular space of a ventricle. The second device may be an annuloplasty implant, a non-annulus valve apparatus implant, a ventriculoplasty implant, or a cardiac rhythm management device.

Multi-window guide tunnel

Described herein are devices and methods for delivering implants that comprise multiple coupled anchors. The anchors are secured to tissue using a multi-opening guide tunnel that is configured to releasably retain one or more portions of the implant located between two of the anchors. The releasable retention of one or more intervening portions of the implant maintains the position of the implant and the guide tunnel until the implant is secured to the tissue. The multi-opening guide tunnel permits securement of the multiple anchors without requiring repositioning of the guide tunnel for each anchor.

Microcoil device with a forward field-of-view for large gain magnetic resonance imaging

Microcoils can be used in medical devices to enhance RF response signals and to create fields to enhance imaging capability in MRI imaging systems. An improved microcoil design includes a device to be inserted into a patient comprising a solid body having at least one pair of radially opposed microcoils physically associated with the solid body, each microcoil having an outside microcoil diameter of 6 mm or less, individual windings of each microcoil together defining a geometric plane for each microcoil, and the plane of each microcoil being parallel to the plane of another microcoil in the pair of radially opposed microcoils.

Delivery devices and methods for heart valve repair

Devices and methods for heart valve repair

Methods and devices provide constriction of a heart valve annulus to treat cardiac valve regurgitation and other conditions. Embodiments typically include a device for attaching a cinching or tightening apparatus to a heart valve annulus to reduce the circumference of the annulus, thus reducing valve regurgitation. Tightening devices may include multiple tethered clips, multiple untethered crimping clips, stabilizing devices, visualization devices, and the like. In one embodiment, a plurality of tethered clips is secured circumferentially to a valve annulus, and the tether coupling the clips is cinched to reduce the circumference of at least a portion of the annulus. Methods and devices may be used in open heart surgical procedures, minimally invasive procedures, catheter-based procedures, and/or procedures on beating hearts or stopped hearts.

Devices and methods for anchoring tissue

Anchors, anchoring systems, anchor delivery devices, and method of using anchors are described. An anchor may be a flexible anchor having two curved legs that cross in a single turning direction to form a loop, wherein the legs are adapted to penetrate tissue. The ends of the curved legs may be blunt or sharp. The anchor can assume different configurations such as a deployed configuration and a delivery configuration, and the anchor may switch between these different configurations. In operation, the anchor may be inserted into tissue by releasing the anchor from a delivery configuration so that the anchor self-expands into the deployed configuration, so that the legs of the anchor may penetrate the tissue in a curved pathway.

Methods and devices for catheter advancement and delivery of substances therethrough

Methods and devices for successively advancing a plurality of catheters over a guide element to a body tissue are described. In some of the methods, the guide element may be attached to the body tissue, which may be accessible minimally invasively. In certain variations, the guide element may not be detached from the body tissue after the catheters have been advanced over the guide element. The methods may further comprise deploying at least one implant from at least one of the plurality of catheters. In some variations, a method may comprise advancing a first delivery catheter to a first region of a body tissue, deploying a first anchor from the first delivery catheter, where the first anchor is attached to a guide element, proximally withdrawing the first delivery catheter, advancing a second delivery catheter over the guide element, and deploying a second anchor from the second delivery catheter.

Electrophysiology catheter system

Described herein are devices and methods for treating tissue, comprising a catheter with a plurality of access sites and a plurality of sensors associated with the access sites. The catheter may be positioned along a tissue surface and the sensors may be used to identify a target site along the tissue surface using the plurality of sensors. Analysis of the tissue surface by the sensors is performed without requiring repositioning of the catheter. In some examples, the access sites of the catheter are side openings along a length of the catheter and the plurality of sensors are electrodes configured to measure electrophysiology parameters. In these examples, the catheter may comprise an internal lumen which permits a treatment device, such as an ablation catheter, to be slidably positioned at the desired target site without requiring displacement of the catheter. In other examples, the catheter may comprise a plurality of fixed ablation elements associated with the plurality of access sites.

Delivery devices and methods for heart valve repair

Disclosed herein are devices, systems and methods for delivering a cinchable anchor device to cardiac tissue. One variation of an anchor delivery system comprises a catheter and a cinchable anchor device having an elongate configuration and an arcuate tensioned configuration. The cinchable anchor device comprises a distal anchor fixedly coupled to a tether, at least one additional proximal anchor that is slidably coupled to the tether, and at least one force distributing member positioned along the tether between the distal anchor and the additional proximal anchor. The force distributing member is configured to reduce the force applied to the distal anchor when the device is in the arcuate tensioned configuration to help prevent pull-out of the distal anchor.

Abgabevorrichtungen für die herzklappenreparatur

Devices for termination of tethers

Devices and methods for locking and/or cutting tethers during a tissue modification procedure are described. In some variations, a tether may be used to tighten or compress tissue by bringing two pieces or sections of the tissue together. The tether, which may be under tension, may be locked to maintain the tension, and excess tether may be severed, using one or more of the devices and/or methods. The devices and/or methods may be used, for example, in minimally invasive procedures.

Devices for termination of tethers

Devices and methods for locking and/or cutting tethers during a tissue modification procedure are described. In some variations, a tether may be used to tighten or compress tissue by bringing two pieces or sections of the tissue together. The tether, which may be under tension, may be locked to maintain the tension, and excess tether may be severed, using one or more of the devices and/or methods. The devices and/or methods may be used, for example, in minimally invasive procedures.

Devices for termination of tethers

Devices for termination of tethers

Methods and devices for deployment of tissue anchors

Described here are devices, methods, and kits for deployment of tissue anchors. In some variations, the devices described here comprise a shaft defining a lumen for housing at least one anchor therein (the anchor having an eyelet) and a mechanism for deploying the anchor distally from the lumen, wherein the inner diameter of the lumen is the same size or smaller than the diameter of the eyelet of the anchor to be disposed therein when the anchor is in an expanded configuration. In some variations, the methods comprise loading an anchor within a lumen of a shaft (where the anchor comprises an eyelet and the shaft has a slot therethrough), passing a linking member through the slot and through the eyelet of the anchor, and deploying the anchor. Other methods comprise loading an anchor within a lumen of a shaft, and deploying the anchor distally from the lumen.

Devices and methods for anchoring tissue

Devices and methods for anchoring tissue

Anchors, anchoring systems, anchor delivery devices, and method of using anchors are described. An anchor may be a flexible anchor having two curved legs that cross in a single turning direction to form a loop, wherein the legs are adapted to penetrate tissue. The ends of the curved legs may be blunt or sharp. The anchor can assume different configurations such as a deployed configuration and a delivery configuration, and the anchor may switch between these different configurations. In operation, the anchor may be inserted into tissue by releasing the anchor from a delivery configuration so that the anchor self-expands into the deployed configuration, so that the legs of the anchor may penetrate the tissue in a curved pathway.

Methods and devices for deployment of tissue anchors

Methods and devices for heart tissue repair

Methods for securing implants to heart tissue are described, where the implants include one or more anchor portions extending from a support. Some variations of the methods may comprise securing an implant to a first region of a tissue in the vicinity of a subannular groove of a heart, where the implant comprises a support and a first anchor portion extending from a first portion of the support. The implant may further comprise a second anchor portion extending from a second portion of the support. Certain variations of the methods may include advancing a catheter to a first region of a tissue in the vicinity of a subannular groove of a heart, and deploying an implant from the catheter to the first region of tissue, where the implant comprises a support and a first anchor portion extending from a first portion of the support. Implants also are described.

Methods and devices for heart tissue repair

Verschlussvorrichtung zur nahtverriegelung