Source: https://patents.google.com/patent/US9173712
Timestamp: 2018-04-24 18:41:32
Document Index: 241559518

Matched Legal Cases: ['Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'art.\n2', 'art.\n18']

US9173712B2 - Over-the-wire cardiac implant delivery system for treatment of CHF and other conditions - Google Patents
Over-the-wire cardiac implant delivery system for treatment of CHF and other conditions Download PDF
US9173712B2
US9173712B2 US13632108 US201213632108A US9173712B2 US 9173712 B2 US9173712 B2 US 9173712B2 US 13632108 US13632108 US 13632108 US 201213632108 A US201213632108 A US 201213632108A US 9173712 B2 US9173712 B2 US 9173712B2
US13632108
US20130096579A1 (en )
This application is related to and claims the benefit of U.S. Provisional Patent Application No. 61/541,980 entitled “Over-The-Wire Cardiac Implant Delivery System for Treatment of CHF and Other Conditions,” filed Sep. 30, 2011. This application is also related to and claims the benefit of U.S. Provisional Patent Application No. 61/541,975 entitled “Remote Pericardial Hemostasis for Ventricular Access and Reconstruction or Other Organ Therapies,” filed Sep. 30, 2011; U.S. Provisional Patent Application No. 61/541,978 entitled “Cardiac Implant Migration Inhibiting Systems,” filed Sep. 30, 2011; and U.S. Provisional Patent Application No. 61/541,624 entitled “Trans-Catheter Ventricular Reconstruction Structures, Methods, and Systems for Treatment of Congestive Heart Failure and Other Conditions,” filed Sep. 30, 2011; the full disclosures of which are incorporated herein by reference in their entirety.
The subject matter of this application is also related to that of US Patent Publication No. U.S.2009/0093670, as published on Apr. 9, 2009 and entitled “Treating Dysfunctional Cardiac Tissue;” and to that of US Patent Publication No. U.S.2010/0016655, as published on Jan. 21, 2010 and entitled “Cardiac Anchor Structures, Methods, and Systems for treatment of Congestive Heart Failure and Other Conditions;” the full disclosures of which are incorporated herein by reference in their entirety.
An exemplary method and implant for closing off a lower portion of a heart ventricle is described in U.S. Pat. No. 6,776,754, the full disclosure of which is incorporated herein by reference. A variety of alternative implant structures and methods have also been proposed for treatment of the heart. U.S. Pat. No. 6,059,715 is directed to a heart wall tension reduction apparatus. U.S. Pat. No. 6,162,168 also describes a heart wall tension reduction apparatus, while U.S. Pat. No. 6,125,852 describes minimally-invasive devices and methods for treatment of congestive heart failure, at least some of which involve reshaping an outer wall of the patient's heart so as to reduce the transverse dimension of the left ventricle. U.S. Pat. No. 6,616,684 describes endovascular splinting devices and methods, while U.S. Pat. No. 6,808,488 describes external stress reduction devices and methods that may create a heart wall shape change. US Patent Publication No. U.S.2009/0093670 describes structures and methods for treating dysfunctional cardiac tissue, while US Patent Publication No. U.S.2010/0016655 describes cardiac anchor structures, methods, and systems for treatment of congestive heart failure and Other Conditions. The full disclosures of all of these references are incorporated herein by reference in their entirety.
While the proposed implants, systems, and methods may help surgically remedy the size of the ventricle as a treatment of congestive heart failure and appear to offer benefits for many patients, still further advances would be desirable. In general, it would be desirable to provide improved devices, systems, and methods for treatment of congestive heart failure. It would be particularly desirable if such devices and techniques could provide increased control over any movement of the components of the implant system during deployment in a beating heart, and/or could decrease the trauma imposed on collateral tissues when gaining access to the target tissues for treatment, when positioning implants and other therapeutic devices for use, and when treating the target tissue. It would be also be beneficial to enhance the accuracy of ventricular reconstruction while simplifying the overall procedure, ideally while decreasing the sensitivity of the therapy on unusual surgical skills. It would be advantageous if these improvements could be provided without overly complicating the structures of implants or implant deployment systems, and while significantly enhancing the benefits provided by the implanted devices.
Embodiments of the present invention provide improved medical devices, systems, and methods, in many cases for reducing the distance between two locations in tissue, optionally in a less or minimally invasive manner. The present invention may find specific use in the treatment of a failing heart, particularly for the alleviation of congestive heart failure and other progressive heart diseases by reconfiguring abnormal heart geometry that may be contributing to heart dysfunction. In many embodiments, implant components will be positioned at least partially within a chamber of the heart. For example, an anchor of an implant system may, when the system is fully deployed, reside within the right ventricle in engagement with the ventricular septum. A tension member may extend from that anchor through the septum and an exterior wall of the left ventricle to a second anchor along an epicardial surface of the heart. Advantageously, an elongate anchor structure having a guidewire lumen can be advanced over the guidewire, facilitating control over the positioning and orientation of the anchor structure as it exits the delivery catheter so as to inhibit inadvertent penetration into tissues bordering the chamber, damage to the chordae tenineae, papillary muscles, valve leaflets, and/or other intracardial structures. Perforating both the exterior wall and the septum from an epicardial approach can also provide beneficial control over the effective reshaping of the ventricular chamber.
In a first aspect, the invention provides a method for treating a heart of a patient including inserting a guidewire through a wall of the heart and inserting a delivery catheter over the guidewire into the heart. The delivery catheter may include a first end, a second end, and a lumen extending between the first end and the second end. An anchor may be inserted over the guidewire and through the lumen of the delivery catheter to a position within a chamber of the heart. The anchor may be coupled with a tension member. The method may also include deploying the anchor within the chamber and applying tension to the anchor via the tension member so as to urge the wall proximally against a second wall of the heart.
The anchor may include a lumen extending along an axis of an elongate structure. Inserting the anchor into the heart may include advancing the anchor structure axially over the guidewire and into the chamber so that the guidewire inhibits injury to tissue structures along or within the chamber by the anchor.
The method may further include inserting a dilating catheter through the wall prior to inserting the delivery catheter to dilate an aperture of the wall as the dilating catheter is inserted therethrough. In some embodiments, the dilating catheter may include a tapering threaded tip that contacts tissue of the wall and the method may additionally include rotating the dilating catheter about a thread axis so that the tapering threaded tip dilates the aperture. In other embodiments, the dilating catheter may include a cutting element disposed toward a distal end of the dilating catheter that cuts tissue of the wall to dilate the aperture.
The method may additionally include inserting a pusher tube through the lumen of the delivery catheter to push the anchor through the lumen of the delivery catheter. The pusher tube may include a first lumen through which the tension member is inserted and a second lumen through which the guidewire is inserted. The anchor may be pivotally coupled with the tension member and may include a first end, a second end, and a lumen extending between the first end to the second end and the method may additionally include inserting the guidewire through the lumen of the anchor to orient the anchor relative to the second lumen of the pusher tube as the anchor is inserted through the lumen of the delivery catheter. The method may additionally include withdrawing the guidewire from the lumen of the anchor after the anchor is positioned within the chamber so that the anchor pivots from a low profile configuration to a deployed configuration.
The method may additionally include positioning a second anchor adjacent the second wall and applying tension to the anchor and the second anchor so as to urge the wall against the second wall. The method may additionally include expanding a laterally deployable member of the pusher tube and/or delivery catheter adjacent the wall and engaging the laterally deployable member against the wall so as to urge the wall toward the second wall. The laterally deployable member may include a balloon, a malecot, a plurality of deployable arms, and the like.
In some embodiments, the delivery catheter may include a catheter body having a first end and a second end, a dilating tip disposed near the second end, a sheath disposed over the catheter body proximally of the dilating tip, and an anchor receptacle configured to removably receive the anchor therein and the method may include proximally retracting the sheath such that the anchor is laterally releasable from the receptacle. The delivery catheter may also include a deployment member disposed toward the dilating tip and the method may include advancing the anchor distally relative to the dilating catheter so that the anchor is laterally deployed from the receptacle via the deployment member.
In some embodiments, the dilating catheter includes a lumen extending between a first end of the dilating catheter and a second end so that the dilating catheter is insertable over the guidewire through the wall along an arcuate path by inserting the guidewire through the lumen.
In another aspect, the invention provides a method for treating a heart of a patient where the heart comprises a chamber bordered by a wall. The method includes inserting a guidewire into the chamber so that the inserted guidewire traverses the wall through an aperture in the wall and inserting a dilating catheter over the guidewire to a position adjacent the wall. The dilating catheter may include a tapering threaded tip having a thread axis and the method may additionally include rotating the dilating catheter about the thread axis as the dilating catheter is inserted through the wall so that the tapering threaded tip contacts tissue of the wall and rotational engagement between the tapering threaded tip and the tissue dilates the aperture of the wall to an expanded aperture.
The method may further include inserting a delivery catheter through the expanded aperture of the wall, inserting an anchor, coupled with a tension member, over the guidewire and through a lumen of the delivery catheter to a position adjacent the wall, and applying tension to the anchor via the tension member so as to urge a septum wall of the heart against a chamber wall of the heart, where the wall of the heart is the septum wall or the chamber wall. The anchor and tension member may be advanced adjacent the wall while the heart is beating and with the anchor axially affixed to the tension member in a low profile configuration. The anchor may be deployed laterally relative to the tension member. Similarly, the anchor may be pivotally coupled with the tension member and may include an elongate shaft having an axial lumen through which the guidewire is inserted. The guidewire may maintain an axial orientation of the anchor extending along the tension member while the anchor is advanced through the lumen of the delivery catheter.
The method may further include coupling an additional anchor with the tension member, positioning the additional anchor adjacent the chamber wall, and applying tension to the anchor and additional anchor via the tension member so as to urge the septum wall against the chamber wall. Applying tension to the anchor and additional anchor may include applying a preselected amount of tension with a tension device, which may provide an indication of the amount of tension applied. The additional anchor may have a variable force mode that allows the additional anchor to slide axially proximally and distally along the tension member and may have a set force mode that inhibits either proximal or distal movement of the additional anchor along the tension member. The tension device may include a first end, a second end, and a lumen extending from the first end to the second end through which the tension member is inserted.
In another aspect, the invention provides a system for treating a heart of a patient, which may include a guidewire insertable through a wall of the heart into a chamber of the heart and a delivery catheter having a first end, a second end, and a lumen extending between the first end and the second end, the delivery catheter being insertable over the guidewire through the wall. The system may also include an anchor comprising a lumen configured to receive the guidewire so that the anchor is insertable over the guidewire through the wall, the anchor being insertable through the lumen of the delivery catheter. The system may further include a tension member coupled with the anchor to urge the wall against a second wall. In some embodiments, the delivery catheter includes a hemostasis valve that limits blood loss from the patient body.
The anchor may include a lumen extending along an axis of an elongate structure. The lumen of the anchor may slidably receive the guidewire therein so as to accommodate advancement of the anchor into the heart by advancing the anchor structure axially over the guidewire and into the chamber. The guidewire may help control a position of the elongate anchor structure and inhibits injury to tissue structures along or within the chamber.
The system may additionally include a dilating catheter having a first end, a second end, and a lumen extending between the first end and the second end, where the lumen is configured to receive the guidewire so that the dilating catheter is insertable through the wall along a path defined by the guidewire. The dilating catheter may have a dilating feature disposed toward the second end that dilates the aperture of the wall as the dilating catheter is inserted through the wall.
The system may additionally include a pusher tube insertable through the lumen of the delivery catheter. The pusher tube may include a first end, a second end, a first lumen extending between the first end and the second end through which the tension member is insertable, and a second lumen extending between the first end and the second end through which the guidewire is insertable. The pusher tube may be configured to push the anchor through the lumen of the delivery catheter.
The anchor may have a fixed orientation relative to the tension member when the guidewire is inserted through the lumen of the anchor and the anchor may be rotatable relative to the tension member when the guidewire is not inserted through the lumen of the anchor. Similarly, the lumen of the anchor may be axially aligned with the second lumen of the pusher tube when the guidewire is inserted through both the second lumen of the pusher tube and through the lumen of the anchor, which axial alignment may facilitate insertion of the anchor through the lumen of the delivery catheter.
The delivery catheter may include a catheter body having a first end and a second end, a dilating tip disposed near a second end of the delivery catheter, a sheath disposed over the catheter body proximally of the dilating tip, and an anchor receptacle configured to removably receive the anchor therein. The anchor may be laterally releasable from the receptacle of the delivery catheter by retracting the sheath proximally. The dilating tip may include a deployment member that deploys the anchor laterally as the anchor is advanced distally relative to the delivery catheter.
The system may additionally include a second anchor slidably coupled with the tension member. The additional anchor may have a variable force mode that allows the additional anchor to slide axially proximally and distally along the tension member and a set force mode that inhibits movement of the additional anchor proximally or distally along the tension member. The system may additionally include an axial force-application tool configured for applying a desired anchor migration inhibiting force between the anchors. The second anchor may be configured for changing from the variable-force mode to the set-force mode while the axial force-application tool applies the desired anchor force between the tension member and the second anchor. The force-application tool may have a compression shaft configured to engage the second anchor through a working lumen of a minimally invasive access tool and the second anchor may be reconfigured between the modes from outside the patient body through the working lumen of the minimally invasive access tool. The pusher tube and/or delivery catheter may include an expandable member that is expandable adjacent the wall and engagable against the wall so as to urge the wall toward the second wall.
In another aspect, the invention provides a method for dilating an aperture of a wall of a patient's heart. The method may include inserting a guidewire through the wall into a chamber of the patient's heart, where the guidewire extends along an arcuate insertion path. The method may also include inserting the guidewire through a lumen of a dilating catheter, where the lumen extends between a proximal end of the dilating catheter and a distal end. The method may further include inserting the dilating catheter distally along the arcuate insertion path so that a dilating feature of the dilating catheter is positioned proximate the wall of the patient's heart and rotating the dilating catheter about an axis as the dilating catheter is inserted through the wall so that a threaded surface at the distal end contacts tissue of the wall to dilate the aperture of the wall to an expanded aperture. The tissue of the wall may comprise scar tissue.
In another aspect, the invention provides a dilating catheter for dilating an aperture of a wall of a patient's heart. The dilating catheter may include a shaft extending between a proximal end and a distal end and a lumen extending from the proximal end to the distal end through which a guidewire is insertable. The shaft may comprise a flexible material that allows the shaft to be inserted along an arcuate path defined by the guidewire. The dilating catheter may also include a tapering threaded tip disposed at the distal end of the shaft that is configured to contact tissue as the shaft is rotated and inserted through the aperture of the wall such that the tapering threaded tip dilates the aperture to an expanded aperture as the dilating catheter is inserted through the wall.
In another aspect, the invention provides a method for treating a heart of a patient, where the heart comprises a chamber bordered by a septum. The method may include inserting a guidewire into the chamber so that the inserted guidewire traverses a wall of the septum through an aperture in the septum wall. The method may also include inserting a dilating catheter over the guidewire to a position adjacent the septum wall, where the dilating catheter includes a tapering threaded distal tip having a thread axis. The method may further include rotating the dilating catheter about the thread axis as the dilating catheter is inserted through the septum wall so that the tapering threaded tip contacts tissue and so that rotational engagement between the tapering threaded tip and the tissue dilates the aperture of the septum wall to an expanded aperture. The method may additionally include inserting a delivery catheter through the expanded aperture of the septum wall, inserting an anchor over the guidewire and through a lumen of the delivery catheter to a position distally of the septum wall (the anchor being coupled with a tension member), and applying tension to the anchor via the tension member so as to urge the septum wall of the heart against a chamber wall of the heart.
FIG. 2A shows a reconstructed left ventricle using a series of implanted anchors so as to mitigate the deleterious effects of congestive heart failure, according to an embodiment of the invention.
FIGS. 3A-3O illustrate a method of reducing the distance between opposed walls of a heart, according to an embodiment of the invention.
FIG. 4A schematically illustrates joining of a femoral access tool path through the right atrium and an endoscopic trans-epicardial access tool path by snaring a guidewire within the right ventricle of the heart, according to an embodiment of the invention.
FIG. 4B schematically illustrates introducing a guidewire into a right ventricle of the heart through an external wall of the left ventricle and through the septum so as to form an epicardial access path, according to an embodiment of the invention.
FIGS. 4C-4E schematically illustrate joining a right atrial access tool shaft with an endoscopic trans-epicardial access tool shaft within the right ventricle by coupling a guidewire and snare advanced along the shafts and into the right ventricle, according to an embodiment of the invention.
FIGS. 5A and 5B schematically illustrate alternative techniques for joining a right atrial access tool shaft and an endoscopic epicardial access tool by snaring a guidewire within the right ventricle or right atrium of the heart using a basket snare, according to an embodiment of the invention.
FIG. 6 illustrates a basket snare and associated access catheter configured for use in the right ventricle, according to an embodiment of the invention.
FIG. 7 schematically illustrates joining a right-atrial access tool path with a trans-epicardial access tool using a snare and associated guidewire configured for coupling within the pulmonary artery, according to an embodiment of the invention.
FIG. 8 schematically illustrates a guidewire that has been pulled along paths joined within the right ventricle so as to extend from outside the patient, through the right atrium, through the right ventricle, through the septum, through the left ventricle, through an exterior wall of the heart, and back outside the patient, according to an embodiment of the invention.
FIG. 9 schematically illustrates expansion of a path through the left ventricle over a guidewire, delivery of an anchor and adjacent tension member through the expanded path and over the guidewire, and controlling movement and orientation of the anchor within the right ventricle using a guidewire extending along a joined path, according to an embodiment of the invention.
FIGS. 10-10F illustrates components of an over-the-wire implant delivery system and their use, according to an embodiment of the invention.
FIGS. 10G-10I illustrate an exemplary axially flexible helical screw-tip dilator and its use for traversing a wall of the heart, according to an embodiment of the invention.
FIGS. 10J-10N illustrate an alternative delivery catheter and guidance member, according to an embodiment of the invention.
FIGS. 11A-11C illustrate an alternative over-the-wire dilating catheter, according to an embodiment of the invention.
FIGS. 12A and 12B schematically illustrate an anchor repositioning leash and its use, according to an embodiment of the invention.
FIGS. 13A-13C schematically illustrate coupling of a tension member to a guidewire so as to facilitate guiding the tension member into and through the heart, according to an embodiment of the invention.
FIGS. 14A-14C schematically illustrate advancing the tension member and anchor along a right ventricle access tool over a guidewire, and out from the access tool and through the septum and an external wall of the left ventricle, according to an embodiment of the invention.
FIGS. 15A-15D illustrate various aspects of an epicardial anchor having a variable-force mode and a set force mode, according to an embodiment of the invention.
FIGS. 16A-16D illustrate an epicardial hemostasis tool having a working lumen to provide access through a tissue tract to a epicardium about an epicardial access path, wherein the tool is configured to compress the external wall of the heart toward the access path so as to provide hemostasis, according to an embodiment of the invention.
FIGS. 17-18B illustrate alternative epicardial anchors which are adapted to be advanced along and reconfigured between a variable-force mode and a set force mode via a working lumen of a minimally invasive epicardial access device, according to an embodiment of the invention.
FIGS. 19A-D illustrate insertion of an epicardial-engagement portion of an anchor over a tension member and through a working lumen of a minimally-invasive access device so as to distribute an anchoring load of an anchor lock along a desired contour, according to an embodiment of the invention.
The present invention generally provides improved medical devices, systems, and methods. Exemplary embodiments of the devices are described for use in reducing the distance between a region along the septum and a region of an external wall of the left ventricle of a heart in a less or minimally invasive manner. Hence, embodiments of the tools and methods described herein may find specific use in the treatment of congestive heart failure and other progressive heart diseases by reconfiguring abnormal heart geometry that may be contributing to heart dysfunction. For congestive heart failure therapies, perforating both the exterior wall and the septum from an epicardial approach can provide significant benefits in control over the locations of implant deployments, thereby effectively enhancing the resulting reshaping of the ventricular chamber. In some embodiments of the invention, the exterior wall and the septum may be perforated using a curved needle. The perforated septum and/or exterior wall may then be dilated to expand or enlarge the aperture through the septum or exterior wall using a dilating catheter, which may include a dilating feature such as a tapering threaded tip, cutting element (RF cutting element), and the like. The dilating catheter may dilate the aperture, such as by cutting tissue, as the dilating catheter is inserted through the exterior wall and/or septum without requiring an excessive axial force to be placed on the exterior wall and/or septum. This may reduce or eliminate arrhythmia or other negative conditions caused by excessive axial pressure exerted on the exterior wall and/or septum. In addition, this wall and/or septum perforation process can be performed while the heart is beating.
In another embodiment, guiding or deploying an implant may involve both the epicardial access path and another access path into and via an access path through the right ventricle. This additional right atrial access path into the heart may be via the superior vena cava, the inferior vena cava, the right atrial appendage, or the like, and the pathways may be joined together by coupling of a snare to a guidewire or the like within the right ventricle, the right atrium, the right pulmonary artery, or the like. While a variety of tools will be described herein for providing access pathways, for joining pathways together within the heart, for deploying implants, for maintaining hemostasis, and the like, it should be recognized that alternative embodiments may employ additional or alternative structures, some of which may be off-the-shelf, and some of which may be new structures configured particularly for use in the advantageous therapies described herein. For example, embodiments of the systems, implants, and techniques described herein may employ components described in U.S.2009/0093670, as published on Apr. 9, 2009 and entitled “Treating Dysfunctional Cardiac Tissue;” and/or in US Patent Publication No. U.S.2010/0016655, as published on Jan. 21, 2010 and entitled “Cardiac Anchor Structures, Methods, and Systems for treatment of Congestive Heart Failure and Other Conditions;’ the full disclosures of which are incorporated herein by reference in their entirety.
Deployment of an anchor within the heart (e.g., the right ventricle) both along a single pathway or joined pathways described above, may be improved by guiding the anchor into the heart over a guidewire. The anchor and/or a tether coupled to the anchor may include a lumen through which the guidewire is inserted that aligns and controls the placement of the anchor within the heart and/or controls deployment of the anchor within the heart. Such placement of the anchor and/or control of the anchor may prevent or reduce the anchor from entangling or interfering with sensitive heart tissues, such as valve leaflets, chordae, papillary muscles, and the like. The guidewire may be positioned within a chamber of the heart (ventricle or atrium), within an artery (e.g., the pulmonary artery), and the like, and the anchor can be advanced to that position over the guidewire so as to avoid sensitive heart tissues. In embodiments where separate pathways are joined, the anchor may be inserted along one pathway, advanced over the guidewire to within a chamber of the heart, and a tether coupled with the anchor may be advanced to a position exterior to the heart along the other pathway. The tether may then be tensioned to urge a wall of the heart toward a second wall (e.g., urge the septum toward an exterior wall of the left ventricle).
Referring now to the figures, FIG. lA shows a normal heart H and FIG. 1B shows the cross-section of normal heart H. Normal heart H includes structures such as the aorta AO, pulmonary artery PU, coronary artery CA, apex AP, right ventricle RV, left ventricle LV with a radius 210, and septum SE.
Myocardial infarction and the resultant scar formation is often the index event in the genesis of congestive heart failure (“CHF”). The presence of the scar, if left untreated, may lead to a compensatory neuro-hormonal response by the remaining, non-infarcted myocardium. FIG. 1C shows a region RE (bordered by a dotted line) of left ventricle LV which includes scar tissue. With congestive heart failure, the left ventricle often dilates or increases in size as shown in FIG. 1D, in which radius 210 has increased to a radius 410. This increase in size can result in a significant increase in wall tension and stress. With disease progression, the volume of the left ventricle LV gradually increases while forward blood flow gradually decreases, with scar tissue expanding while unscarred muscle dilates and becomes thin, losing contractility. The systems, methods, and devices described herein may be applied to inhibit, reverse, or avoid this response altogether, often halting the destructive sequence of events which could otherwise cause the eventual failure of the remaining functional heart muscle.
Embodiments of the invention may build on known techniques for exclusion of the scar and volume reduction of the ventricle. Unlike known techniques that are often accomplished through open surgery, including left ventricular reconstruction, ventricular restoration, the Dor procedure, and the like, the treatments described herein will often (though not necessarily always) be implemented in a minimally invasive or less invasive manner. Embodiments of the invention can provide advantages similar to those (for example) of surgical reconstruction of the ventricle, resulting in improved function due to improved dynamics, and by normalizing the downward cycle initiated by the original injury and mediated by the neuro-hormonal disease progression response.
Referring now to FIGS. 2A and 2B, a series of implants 10 are shown implanted in a heart H so as to decrease a cross-section of a left ventricle LV. Each implant 10 generally includes a first anchor 12, a second anchor 14, and a tension member 16 coupling the anchors together. Tension in the tension member 16 is transferred from the anchors 12, 14 to the septum S and the external wall EW bordering the left ventricle LV so as to bring these structures into engagement, thereby effectively excluding a region of scar tissue ST from the left ventricle. In many embodiments described herein, implant 10 will be deployed by penetrating the external wall EW and septum SE via a pericardium P of the heart H, and also by accessing a right ventricle RV via a right atrium. Anchors deployed within a right ventricle and/or in engagement with the septum SE may sometimes be referred to herein as septal anchors, while anchors deployed along the external wall EW of the left ventricle LV may be referred to as epicardial anchors.
Referring now to FIGS. 3A-3O, shown is a method of reducing the distance between opposed walls of a heart H, and specifically of reducing the distance between the septum SE and the external wall EW of the left ventricle LV. In some embodiments, the method is performed endoscopically, percutaneously, or otherwise in a minimally or less invasive manner. The heart may be accessed through, for example, a small incision made between the ribs or a thoracotomy. As shown in FIG. 3A, a bent insertion needle or guidewire introducer 320 is passed through a desired insertion path through the left ventricle LV wall and through septum SE into the right ventricle RV. Guidewire introducer 320 may be configured so that the perforations made by guidewire introducer 320 on the left ventricular wall and the septum wall are perpendicular to their respective walls. As shown in FIG. 3B, a guidewire 311 is placed through the lumen of guidewire introducer 320 so that guidewire 311 threads through the outer left ventricle LV wall, through the septum SE, and into the right ventricle RV. Guidewire 311 may be inserted along and may define an epicardial access path, which may be an arcuate path. As shown in FIG. 3C, guidewire introducer 320 is removed from the heart leaving guidewire 311 threaded through the external wall EW, left ventricle LV, and septum SE into right ventricle RV. Examples of bent insertion needle or guidewire introducer 320 may be found in US Patent Publication No. U.S.2010/0016655 that is incorporated herein by reference as described previously.
FIG. 3D shows a dilating catheter 324 inserted within a lumen of a delivery catheter 326 with the dilating catheter 324 and delivery catheter 326 being advanced over the guidewire 311 to external wall EW of heart H. Delivery catheter 326 may include a hemostasis valve at a proximal end outside the heart to minimize blood loss from the patient. Guidewire 311 is inserted through a lumen of dilating catheter 324. Additional aspects of dilating catheter 324 and delivery catheter 326 are shown in FIG. 10. In other embodiments, such as the embodiments illustrated in FIGS. 11A-11C the delivery catheter and dilating catheter may be combined into a single catheter device.
Dilating catheter 324 may dilate or enlarge an aperture in septum SE and/or external wall EW formed from inserting guidewire introducer 320 through septum SE and/or external wall EW. To dilate the aperture through septum SE and/or external wall EW, dilating catheter 324 includes a dilating feature at the distal tip. For example, in some embodiments, dilating catheter 324 comprises a tapering threaded tip 325 as shown in more detail in FIG. 10. Dilating catheter 324 may be rotated 323 about an axis as dilating catheter 324 is inserted through septum SE and/or external wall EW to dilate the aperture. The threaded surface of tapering threaded tip 325 contacts tissue of the septum SE and/or external wall EW and cuts the tissue, compresses the tissue, or otherwise widens the aperture. The tapered threaded tip 325 reduces the amount of axial pressure that is otherwise applied to septum SE and/or external wall EW as a delivery catheter is inserted therethrough, which may reduce arrhythmia or other conditions resulting from axial pressure exerted on the septum SE and/or external wall EW. In other words, rotation of tapering threaded tip 325 may help advance delivery catheter 326 with less axial force than would otherwise be used to axially advance a tapered catheter, and may limit axial force to the septum sufficiently to inhibit arrhythmia of the heart. The tissue contacted by the tapered threaded tip 325 may include scar tissue ST, which generally is tough or otherwise difficult to penetrate and which, therefore, requires an appreciable amount of axial force to penetrate. Dilating catheter 324 and/or delivery catheter 326 may be formed of a flexible material so that dilating catheter 324 may be rotated while being bent along the arcuate epicardial access path of guidewire 311. Put another way, rotation of dilating catheter 324 may be transmitted axially over guidewire 311 around the arcuate epicardial access path. Dilating catheter 324 may alternatively include a cutting element instead of or in addition to tapered threaded tip 325. The cutting element may use RF energy (e.g., an RF transceptal needle) to cut through the tissue of the septum SE and/or external wall EW. Such RF devices are described herein. Likewise, delivery catheter 326 and/or dilating catheter 324 may be steerable catheters so that a distal end of catheters, 324 and/or 326, may be positioned virtually anywhere within right ventricle (e.g., near the pulmonary artery and the like).
FIGS. 10G-10I illustrate an alternative embodiment of a dilation catheter 324′ having a tapered threaded tip 325′. In this embodiment, tapered threaded tip 325′ is configured to rotationally advance or screw into and through tissue of external wall EW and/or septum SE. Dilation catheter 324′ includes inner and outer concentric shafts that extend proximally of tapered threaded tip 325′ toward a proximal hub 323′. The shafts are laterally flexible to accommodate curvature of the axis of the dilation catheter, and the hub 323′ and tapered threaded tip 325′ may be axially coupled to the inner shaft and the inner shaft may be sufficiently axially stiff so that rotation of the hub 323′ outside the body induces controlled rotation of the tapered threaded tip 325′ into and through the tissue of external wall EW and/or septum SE while the outer shaft remains rotationally stationary.
FIG. 3H shows septal anchor 332 being inserted within a proximal end of delivery catheter 326. Septal anchor 332 is positioned within loading cartridge 334 that fits at a distal end within the hemostasis valve of delivery catheter 326 and that couples at a proximal end with pusher tube 336. Loading cartridge 334 facilitates insertion of septal anchor 332 and pusher tube 336 within delivery catheter 326. Additional aspects of septal anchor 332, loading cartridge 334, and pusher tube 336 are shown in FIG. 10. Septal anchor 332 is rotatably coupled with tether or tension member 333 at pivot point 333 a. Septal anchor 332 includes a lumen through which guidewire 311 is inserted so that septal anchor 332 is advancable over the guidewire. The lumen of septal anchor 332 may extend along an axis of the septal anchor 332. The lumen may slidably receive guidewire 311 therein so as to accommodate advancement of septal anchor 332 into heart H by advancing septal anchor 332 axially over guidewire 311 and into the right ventricle RV. Guidewire 311 may help control a position of septal anchor 332 and inhibit injury to tissue structures along or within the heart H, right ventricle RV, and/or left ventricle LV, such as valve leaflets, chordae, papillary muscles, and the like.
FIG. 3I illustrates septal anchor 332 advanced through delivery catheter 326 via pusher tube 336 into the right ventricle RV of heart H over guidewire 311. Guidewire 311 maintains septal anchor 332 in the axially aligned relationship with pusher tube 336 and tether 333. FIG. 3I also shows the guidewire 311 exiting pusher tube 336 via guidewire port 343 and shows tether 333 exiting pusher tube 336 via tether port 345. Additional aspect of guidewire port 343 and tether port 345 are shown in FIG. 10. Because septal anchor 332 is guided into the right ventricle RV over guidewire 311, septal anchor 332 may be positioned virtually anywhere guidewire 311 is positioned, such near the pulmonary artery and the like. Such positionability of septal anchor 332 allows sensitive heart tissues, such as valve leaflets, chordae, papillary muscles, and the like, to be avoided or contact therewith minimized. Further, positioning septal anchor 332 over guidewire 311 minimizes entanglement with and/or contact between septal anchor 332 and sensitive heart tissues, such as valve leaflets, chordae, and the like, because septal anchor 332 is fixed in relation to tether 333 and pusher tube 336 and not able to freely rotate and entangle with or contact such features of heart H.
Septal anchor 332 may optionally be advanced into and/or within heart H by pushing the anchor distally using a flexible compressive shaft of pusher tube 336, 1036, or the like. In either case, the compressive shaft being used as a pusher catheter may have separate lumens for guidewire 311 and tether 333 as shown, with both lumens extending between the distal end and the proximal end of the catheter body. More than 2 lumens may also be provided, and the multi-lumen structure can enhance rotational control over septal anchor 332 about the axis of tether 333, and/or may facilitate orienting the arms of septal anchor 332 by rotation of the pusher tube 336/1036 (optionally along with tether 333 and guidewire 311 therein) from outside the patient. In some embodiments, tether 333 may have an elongate cross-section and tether lumen 341/1041 may have a corresponding elongate cross-section so as to enhance rotational control over the advanced septal anchor 332 after guidewire 311 is pulled free of septal anchor 332, as can be understood with reference to the distal end of pusher tube 1036 shown in FIG. 10C, and with reference to the elongate cross-section of the large tether lumen 341 of pusher catheter 336 shown in FIG. 10F. In some embodiments, one of the unnumbered lumens on either side of guidewire lumen 339 may receive guidewire 311.
FIG. 3J shows guidewire 311 being removed from the right ventricle via guidewire port 343 and from the guidewire lumen of septal anchor 332. Removal of guidewire 311 from the guidewire lumen of septal anchor 332 allows septal anchor 332 to pivot about pivot point 333 a so that septal anchor 332 is rotatable relative to tether 333. Control over the pivoting of septal anchor 332 may be provided by using leash 312 as shown in FIGS. 12A-12B. For example, once septal anchor 332 is disposed within right ventricle RV and beyond delivery catheter 326, guidewire 311 can be removed and septal anchor 332 positioned transverse to tether 333 by engagement between septal anchor 332 and the surface of septum SE, or by pulling on leash 312 extending through catheter 326 or pusher tube 336. Radial positioning of septal anchor 332 can be provided by rotating the end of tether 333, which remains outside the patient.
FIG. 3J further shows a laterally deployable member 328, such as deployable arms 1031 of pusher tube 1036 of FIGS. 10B-10C, deployed from the distal end of pusher tube 336 so as to stabilize the pusher tube 336 and delivery catheter 326 relative to the beating heart tissue around left ventricle LV. Suitable deployable members 328 may include a malecot, a pair of opposed deployable arms (optionally similar to those described below with reference to FIGS. 10B and 10C), a balloon, or the like. Laterally deployable member 328 may be configured for engagement against an interior surface of the left ventricle LV or against the epicardial surface of the left ventricle (such as by having the deployable structure spaced proximally of the distal end). Laterally deployable member 328 may be used to urge septum SE toward external wall EW and thereby provide additional space within right ventricle RV for the deployment of septal anchor 332 and/or may facilitate tensioning of septal anchor 332 and an epicardial anchor to reshape heart H. Some embodiments do not involve laterally deployable member 328 and septal anchor 332 is deployed directly within the space of right ventricle RV. Deployable members 328 may be deployed within right ventricle RV before or after guidewire 311 is removed and septal anchor 332 released from the fixed orientation.
FIG. 3K shows delivery catheter 326 and pusher tube 336 being removed from the right ventricle RV of heart H so that septal anchor 332 is positioned against the surface of the wall of septum SE. Tether 333 extends from septal anchor 332 through the aperture in septum SE and external wall EW to the exterior of heart H. Tension may be applied to tension member 333 to urge septum SE toward external wall EW. FIG. 3L shows an epicardial anchor 355 coupled with tension member 333 and being advanced toward external wall EW via anchor set tool 359. Epicardial anchor 355 includes a lumen 353 (shown in FIGS. 10, 10D, 10E, and 15A-15D), through which tether 333 is inserted. Epicardial anchor 355 has a spring cam structure 363 as more fully shown in FIGS. 15A-15D and described in US Patent Publication No. U.S.2010/0016655, as published on Jan. 21, 2010 and entitled “Cardiac Anchor Structures, Methods, and Systems for treatment of Congestive Heart Failure and Other Conditions;” the full disclosures of which are incorporated herein by reference. The spring cam 363 allows epicardial anchor 355 to slide along tether 333 toward septal anchor 332, but inhibits sliding of epicardial anchor 355 away from septal anchor 332, so that the spring cam 363 effectively maintains a tissue engagement force between the anchors. This set-force interaction between tether 333 and epicardial anchor 355 is advantageous once the proper force is applied, but it can be challenging to apply the desired force when the heart is beating. To more accurately apply septal/external wall engagement forces within a desired range, anchor set tool 359 can engage the cam spring mechanism 363 of epicardial anchor 355 so as to allow the anchor to slide both axial directions along tether 333 (shown in FIG. 10E), thereby configuring epicardial anchor 355 into a variable force mode. This allows a controlled force to be applied between the tether 333 and epicardial anchor 355 despite beating of the heart, with the force preferably being applied by a force application tool 314 having an elongate shaft 316 as described in FIG. 3M.
The applied anchor force may be an appropriate amount of force to bring external wall EW and septum SE into engagement while preventing migration of epicardial anchor 355 and septal anchor 332 relative to external wall EW and septum SE, respectively. For example, the force may be sufficient so that an inner surface of external wall EW and septum SE directly contact each other and so that epicardial anchor 355 and septal anchor 332 are secured tightly about external wall EW and septum SE, respectively, but not too strong to cause epicardial anchor 355 and/or septal anchor 332 to be pulled through and/or into external wall EW and/or septum SE. The appropriate anchor force to sufficiently secure the anchors about the heart walls while preventing migration may fall within a range of forces, which may vary from patient to patient. In some embodiments, the anchor force range may be between about 2 Newtons and about 6 Newtons and in other embodiments, may be between about 3 Newtons and about 4 Newtons. Such forces were found to be sufficient enough to prevent migration of the anchors without causing the anchors to be pulled through the external wall EW and/or septum SE. Such forces were also found to minimize necrosis of the tissue of external wall EW and/or septum SE surrounding the anchors.
The force application tool 314 may provide an indication (e.g., via indicia 315) of the force applied so that a force within the desired force range may be applied to the anchors. Further, force application tool 314 and/or epicardial anchor 355 may be configured to apply the appropriate force while the heart is beating. For example, the variable force mode of epicardial anchor 355, allowing proximal and distal movement of epicardial anchor 355 about tether 333, and/or a spring mechanism 313 of force application tool 314 may allow epicardial anchor 355 and force application tool 314 to compensate for movement of heart H as the heart beats and as the desired anchor force is applied to ensure that too little or too much force is not applied. Force application tool 314 may also be configured so that the applied anchor force cannot exceed a predetermined value. For example, force application tool 314 may be configured so that an operator of force application tool 314 cannot apply an anchor force greater than 6 Newtons, or in some embodiments, greater than 4 Newtons. In this manner, necrosis of heart tissue, migration of the anchors, pulling of the anchors through the heart tissue, and/or other potential problems associated with excessive or insufficient anchor forces may be minimized or eliminated.
As shown in greater detail in FIGS. 10D, 10E, and 15A-15D, to engage the cam spring mechanism 363 of epicardial anchor 355, anchor set tool 359 may include a pair of hooks 368 that are positionable around a pair of arms 364 that are in turn connected to cam spring mechanism 363 or otherwise operational therewith. A retractable rod 367 may be positioned between the pair of hooks 368. Rod 367 may be retracted within a sheath 371 or extended therefrom upon actuation of a retracting device, such as a rotatable cap 357. In operation, the pair of hooks 368 may be clamped around arms 364 so that housing 365 is positioned between hooks 368. Retracting device (e.g., rotatable cap 357) is then operated so that rod 367 extends from sheath 371 and contacts housing surface 366. Further operation of retracting device (e.g., rotatable cap 357) forces rod 367 to push on housing surface 366, which causes hooks 368 to pull on arms 364, which in turn causes cam spring mechanism 363 to rotate so that the cam rotates away from contact with tether 333 thereby permitting epicardial anchor 355 to slide both toward and away from septal anchor 332. Similarly, retracting device (e.g., rotatable cap 357) may be operated in a reverse manner so that rod 367 is retracted within sheath 371 and arms 364 resiliently return to a position in which the cam rotates to contact tether 333 thereby inhibiting epicardial anchor 355 from sliding away from septal anchor 332. Arms 364 may act as a spring to bias the cam toward tether 333 and lock epicardial anchor 355 about tether 333. The retracting device (e.g., rotatable cap 357) may be operated from outside the patient body so as to lock/reconfigure epicardial anchor 355 in the set force mode or unlock/reconfigure epicardial anchor 255 in the variable force mode.
Alternative embodiments of an epicardial anchor structure, 1700 and 1800, are shown in FIGS. 17-18B. Epicardial anchor structures, 1700 and 1800, can be advanced axially through a working lumen (optionally through a working lumen of the epicardial hemostasis device described herein) and can also be reconfigured between a set-force mode and a variable-force mode through the access lumen. Epicardial anchor structures, 1700 and 1800, may include a lock plate 1720 or a pair of lock plates within lumen body 1710. The lock plate or plates 1720 may include an aperture through which tether 333 is inserted. Lock plates 1720 may be biased toward a distal end of epicardial anchor structures, 1700 and 1800, via a spring 1730 disposed within lumen body 1710. Locking plates 1720 may pivot within lumen body 1710 to assume a lock position and grip tether 333 and thereby lock epicardial anchor structures, 1700 and 1800, about tether 333 to prevent proximal movement of the anchors relative to tether 333. Locking plates 1720 may also pivot within body lumen 1710 to assume an unlock position and disengage tether 333 and thereby allow epicardial anchor structures, 1700 and 1800, to move distally and proximally relative to tether 333. Spring 1730 may bias locking plates 1720 toward the lock position. For example, the aperture of lock plates 1720 may have a shape corresponding to tether 333 and may be sized slightly larger than tether 333. In the unlock position, lock plates 1720 may assume a vertical position within lumen body 1710, or put another way, lock plates may have a substantially perpendicular orientation with respect to tether 333. Because the aperture of lock plates 1720 corresponds in shape to tether 333 and is sized slightly larger, tether 333 is able to freely pass through the aperture. In the lock position, lock plates 1720 may assume an angled orientation with respect to tether 333, which causes the aperture of lock plates 1720 to kink, grip, or otherwise grasp tether 333 and prevents movement of tether 333 through the aperture. In some embodiments, epicardial anchor structures, 1700 and 1800, may move distally along tether 333 when lock plates 1720 are in the lock position and only proximal motion may be limited.
Referring now to FIGS. 10, 10A, and 10D-10F, shown are the various tools that may be used in the process described in relation to FIGS. 3A-3O. FIGS. 10 and 10A show the delivery catheter 326, which includes a lumen 317 that extends between a proximal end 318 and a distal end 319. Various other catheters or tools, such dilating catheter 324, loading cartridge 334, and pusher tube 336 may be inserted partially or fully within lumen 317. Delivery Catheter 326 includes a hemostasis valve (not shown) located at the proximal end 318, which minimizes blood loss during the minimally invasive surgery.
FIGS. 10, 10A, and 10E show the dilating catheter 324 having the tapering threaded tip 325 and a lumen 323 extending between a proximal end 318 a and a distal end 319 a of dilating catheter 324. The guidewire 311 is insertable through the lumen 323 so that the dilating catheter may be inserted over the guidewire along an access path, which may be an arcuate path, and through one or more walls of the heart as described herein. FIGS. 10A and 10E show a detail view of the tapering threaded tip 325. The threads contact, grip, and/or cut tissue of the heart wall as the dilating catheter 324 is rotated and inserted through the wall. This minimizes the axial forces exerted against the heart wall, which may reduce arrhythmia and other conditions of the heart resulting from such axial stress. In some instances, the heart wall (e.g., septum SE and/or external wall EW) comprises tough scar tissue, which may be difficult to penetrate.
FIGS. 10 and 10F show aspects of the pusher tube 336 and loading cartridge 334. FIG. 10F shows the pusher tube 336 having 4 lumens, which include the guidewire lumen 339, through which guidewire 311 is inserted, and tether lumen 341, through which tether 333 is inserted. Guidewire 311 may be inserted within guidewire lumen 339 at a distal end 319 b of pusher tube 336 and exit pusher tube 336 via guidewire port 343 at a proximal end 318 b. Similarly, as shown in FIG. 10, tether 333 may be inserted within tether lumen 341 at distal end 319 b and exit pusher tube 336 via tether port 345 at proximal end 318 b. Loading cartridge 334 may be coupled with pusher tube 336 at distal end 319 b and inserted within lumen 317 of delivery catheter 326.
FIGS. 10, 10D, and 10E show aspects of septal anchor 332, epicardial anchor 355, anchor set tool 359, and tether 333. Specifically, the figures show septal anchor 332 coupled with tether 333 at pivot point 333 a. The figures also show epicardial anchor 355 with lumen 353 through which tether 333 is inserted as shown in FIG. 10E. FIG. 10D shows epicardial anchor 355 disconnected from anchor set tool 359. FIG. 10D also shows sheath 371, retractable post 367, and hooks 368 of anchor set tool 359 and shows outer layer 362, housing surface 366, lumen 353, and arms 364 of epicardial anchor 355. As described previously, hooks 368 are used to grip arms 364 and post 367 contacts housing surface 366 to actuate cam 363 upon actuation of rotatable cap 357 and thereby configure epicardial anchor 355 in either a variable force mode or a set force mode. As shown in FIG. 10E, epicardial anchor 355 is slidable along the length of tether 333 when epicardial anchor is in the variable force mode. When epicardial anchor is in the set force mode, epicardial anchor 355 may be slid toward septal anchor 332, but not away therefrom.
FIG. 10 also shows force application tool 314 having an elongate shaft 316, force spring 313, and indicia 315 as described previously. Indicia 315 may include a series of marks spaced along elongate shaft 316. Force spring 313 and indicia 315 are housed within main body 307, which may be made of a clear material so that indicia 315 is visible from outside main body 307. Force application tool 314 includes a lumen 309 that extends between a proximal end 318 c and a distal end 319 c through which tether 333 is inserted. Force application tool 314 applies a force against epicardial anchor 355 as tether 333 is tensioned from proximal end 318 c and main body 307 is pushed toward epicardial anchor 355.
Referring now to FIGS. 10B and 10C, shown is another embodiment of a pusher tube 1036, which may be inserted through lumen 317 of delivery catheter 326. Similar to pusher tube 336, pusher tube 1036 includes four lumens. Guidewire lumen 1039 is a lumen through which guidewire 311 may be inserted. Guidewire lumen 1039 extends from distal end 1019 to guidewire port 1043 at proximal end 1018. Similarly, tether lumen 1041 is a lumen through which tether 333 may be inserted. Tether lumen 1041 extends from distal end 1019 to tether port 1045 at proximal end 1018. Pusher tube 1036 also includes a pair of opposed deployable arms 1031, which are housed within lumens 1052 and deployable axially and laterally therefrom. Deployable arms 1031 may be deployed so that the arms radially extend from pusher tube 1036. Deployable arms 1031 may then be engaged against an interior surface of one of the heart walls to stabilize pusher tube 1036 and/or delivery catheter 326 and facilitate in deployment of septal anchor 332 and/or epicardial anchor 335. In some embodiments, pusher tube 1036 includes a malecot and/or balloon, which provides a similar function to deployable arms 1031. Further, in some embodiments, deployable arms comprise nitinol springs and are deployable from lumens 1052 or retractable within lumens 1052 upon rotation of main body 1050 or upon operation of an actuation device located at proximal end 1018.
Referring now to FIGS. 11A-11C, shown is another embodiment of a delivery catheter 1126. Delivery catheter 1126 may replace the separate delivery catheter 326 and pusher tube 336 by combining these tools into one tool. Delivery catheter 1126 may include a catheter body 1142 having a tapered distal tip 1124 at distal end 1119 and a sheath 1145 disposed over catheter body 1142 proximally of tapered distal tip 1124. Sheath 1145 may be proximally retractable relative to catheter body 1142 to expose anchor receptacle 1144, which houses septal anchor 332. Anchor receptacle 1144 may be coupled with tether port 1143 at proximal end 1118 so that tether 333 extends along the length of catheter body 1142 from proximal end 1118 to anchor receptacle 1144. Catheter body 1142 may include a guidewire lumen through which guidewire 311 may be inserted. The guidewire lumen may extend along catheter body 1142 and couple with guidewire port 1145 through which guidewire 311 exits delivery catheter 1126. Sheath 1145 may include a stop 1160 which limits proximal retraction of sheath 1145 by contacting main body 1150. In some embodiments, stop 1150 is positioned adjacent external wall EW and catheter body 1142 is advanced distally to expose anchor receptacle 1144.
Operation of delivery catheter 1126 is similar to delivery catheter 326 described in
FIGS. 3A-3O in that guidewire 311 is inserted through external wall EW and septum SE into right ventricle RV and delivery catheter 1126 is inserted over guidewire 311 into right ventricle RV. One difference is that septal anchor 332 need not include a lumen through which guidewire 311 is inserted since septal anchor 332 is housed within anchor receptacle 1144 and inserted into right ventricle RV while housed within anchor receptacle 1144. Tapered distal tip 1124 dilates the aperture through external wall EW and/or septum SE as delivery catheter is inserted through the respective wall. Although not shown, tapered distal tip 1124 may be threaded as described herein. After distal end 1119 of delivery catheter 1126 is positioned within right ventricle RV, sheath 1145 is proximally retracted (or catheter body is distally advanced) exposing anchor receptacle 1144. Septal anchor 332 is then laterally deployed from anchor receptacle 1144 via deployment member 1170 by distally advancing septal anchor 332 relative to catheter body 1142. With septal anchor 332 deployed within right ventricle RV, delivery catheter 1126 may be removed and epicardial anchor 355 secured to tether 333 as described herein to limit the volume of left ventricle LV. In some embodiments, delivery catheter 1126 may comprise a flexible material to allow delivery catheter 1126 to follow an arcuate epicardial access path defined by guidewire 311.
Referring now to FIG. 4A, joining of an access path through the right atrium to an access path through the pericardium and epicardium by snaring of a guidewire within the right ventricle under thoracoscopic guidance 20 is schematically illustrated. The right atrial access path may extend into the arterial vasculature via the femoral artery FA and inferior vena cava IVC, via the jugular artery JA via the superior vena cava SVC, or the like. As can be understood with reference to FIG. 4B, a selected location for perforation of the external wall EW can be identified using an image from thoracoscope 20, optionally in combination with an image from another imaging modality (such as a prior or contemporaneous image from an ultrasound imaging system, an MRI imaging system, an X-ray or fluoroscopic imaging system, a CT imaging system, or the like). In exemplary embodiments, a rigid or semi-rigid shaft of an access tool 22 having a working lumen therethrough is advanced through the epicardium of the beating heart so that a distal end of the shaft is disposed within the left ventricle LV. Access tool 22 may comprise a relatively simple needle or trocar, an may have a proximal hemostasis valve at its proximal end so as to inhibit blood flow through the lumen and facilitate insertion and/or removal of a guidewire and the like. In some embodiments, access tool 22 may have a tissue penetrating sharpened distal end to facilitate distal insertion, and/or a stylus may be removably disposed within the lumen. Optional embodiments of access tool 22 may have an energy delivery surface at or near the distal end so as to deliver radiofrequency energy, laser energy, or the like to facilitate penetrating the tissue of the external wall EW. Suitable RF penetrating structures may be commercially available from (or modified from those available from) Baylis Medical of Toronto Canada.
Still referring to FIG. 4B, access tool 22 may optionally include a laterally deployable structure near the distal end so as to stabilize the access tool relative to the beating heart tissue around the left ventricle. Suitable deployable stabilizing structures may include a malecott, a pair of opposed deployable arms (optionally similar to those described below with reference to FIGS. 10B and 10C), or the like. The laterally deployable distal structure may be configured for engagement against an interior surface of the left ventricle LV or against the epicardial surface of the left ventricle (such as by having the deployable structure spaced proximally of the distal end). Regardless, once access tool 22 is disposed within the left ventricle, a catheter 24 may be advanced through the working lumen of access tool 22, into the left ventricle, and through a target location of the septum S. A guidewire 26 will also be inserted through the left ventricle and septum as shown. A variety of structures and techniques can be used for perforating the septum, with the catheter optionally being used to penetrate the septum in some embodiments, with the catheter optionally having a sharpened end, a removable stylus, an energy delivery surface, or the like. When catheter 24 perforates the septum, the catheter will often have steering capabilities so as to facilitate perforation at a target location, though in some embodiments catheter 24 may be steered using steering capabilities of the guidewire within the working lumen, a steering catheter extending around the catheter and through the working lumen of access tool 22, or the like. In other embodiments, guidewire 26 may be used to perforate through the septum, with the guidewire optionally having an energy delivery tip and/or steering capabilities, with the catheter being advanced through the septum over the guidewire. Exemplary steerable guidewires with RF penetrating tips include those commercially available from (or may be derived from those available from) Baylis Medical of Toronto Canada.
A wide variety of alternative septum perforation approaches might be employed, including using atrial septum perforation structures and techniques (or structures and techniques derived therefrom). For example, mechanical systems may employ a sharpened distal tip and axial penetration (such as using structures commercially available from—or structures derived from the SafeSept™ transseptal guidewire commercially available from Adaptive Surgical, LLC; the Across Transseptal Access System commercially available from StJude, or the like, a rotatable angled blade, the transseptal puncturing structures and methods described by Wittkampf et al, in U.S.2011/0087261, or the like. RF systems may employ a proprietary tissue penetrating structure or may energize an off-the-shelf transseptal needle with RF energy, as was described by Knecth et al. in an article entitled “Radiofrequency Puncture of the Fossa Ovalis for Resistant Transseptal Access,” Circ Arrhythm Electrophysiol 1, 169 (2008). Laser-energy transseptal approaches may also be employed, including structures commercially available from (or derived from those commercially available from) Spectranetics and others.
Referring now to FIGS. 4C-4E, a distal end of catheter 30 may be advanced to the right ventricle RV through the right atrium RA and associated vasculature using known techniques, so that catheter 30 provides a right ventricle access tool. Optionally, a snare tool has a distal portion configured to engage a distal portion of the guidewire. For example, distal snare 32 may be separated from a proximal end of a snare body by sufficient length of the snare body to allow the snare to be manipulated within the right ventricle from the proximal end of catheter 30. Snare 32 may be biased to open when advanced beyond catheter 30, allowing the catheter to be positioned near the septum around the epicardial path of catheter 24. Advancing guidewire 26 through the opening of snare 32 and withdrawing snare 32 into catheter 30 so that the guidewire is bent as it enters the distal end of catheter 30 axially couples the guidewire to the snare.
Referring now to FIG. 9, once guidewire 26 extends from the first end, into the right ventricle along the epicardial access path, and back out the heart and patient through the left ventricle along the epicardial access path, septal anchor 32 and tether 33 may be advanced over guidewire 26 into right ventricle RV and/or adjacent septum SE. Tether 33 may be advanced over guidewire 26 as shown in FIGS. 13A-14C and may be advanced ahead of septal anchor 32 so that tether 33 extends from adjacent septum SE, through left ventricle LV, to outside the patient body as shown in FIG. 9. Guidewire 26 may then be removed so that septal anchor 32 may rotate relative to tether 33 as described herein. Epicardial anchor 35 may them be coupled with tether 33 and advanced adjacent external wall EW, a force may be applied between epicardial anchor 35 and tether 33, and epicardial anchor 35 may be secured relative to tether 33 and septal anchor 32 as described herein.
Referring now to FIGS. 13A-14C, alternative embodiments of the systems may be configured to deliver septal anchor 32 to the right atrium along the right atrial path, typically with septal anchor 32 trailing behind tether 33. An end of tether 16 is generally disposed opposite of anchor 32, and may include features to maintain the tether in alignment along the guidewire, and may also axially couple the tether to the guidewire. For example, a channel such as angled channel, 64 a or 64 b, may receive the guidewire 31 therein, allowing the tether to be pushed axially over the guidewire. One or more additional channels 66 (shown in FIG. 13C) through tether 33 toward anchor 32 may help limit bowing of the tether 33 away from guidewire 31 when tether 33 is pushed axially over guidewire 31. As can be understood with reference to FIGS. 14A-14C, end 70 of tether 33 is advanced over guidewire 31 and into a proximal hemostasis valve 29 of catheter 30. By continuing to push tether 33 into catheter 30, and/or by pulling guidewire 31 from the end extending from the epicardial path, end 70 of tether 33 may be advanced into and through the septum SE and external wall EW so that end 70 is disposed outside the heart and the patient. Optionally, tether 33 may be advanced along the epicardial path alongside guidewire 31. In other embodiments, catheter 30 or another catheter body may be advanced over the guidewire with tether 33 disposed in a lumen.
Referring now to FIGS. 10J-10N, illustrated are various components that may be used to guide the septal anchor 32 and tether 33 over guidewire 26 into right ventricle RV and/or adjacent septum SE. These components are especially useful in the anchor placement method shown in FIGS. 9 and may be an alternative to the guidewire 26—tether 33 coupling features shown in FIGS. 13A-13C and described herein. FIG. 10J illustrates the septal anchor 32 and tether 33 as described herein. A lumen extends axially through the septal anchor 32 and is configured to receive a release wire 31 a, or in some embodiments the guidewire, to allow the septal anchor 32 to be delivered and positioned in the heart. A guidance member 80 may be coupled with a distal end 37 of tether 33 as described in more detail below to allow the tether 33 and septal anchor 32 to be conveniently guided into the heart. The guidance member 80 may be configured to pass over to the guidewire 31 to guide the septal anchor 32 and tether 33 into position within the heart. An insertion catheter 50 may also be used to support the septal anchor 32 during insertion of the septal anchor 32 and tether 33. Insertion catheter 50 may include a hemostasis valve 54.
FIGS. 10K and 10L illustrate the insertion catheter 50 being used to support septal anchor 32. Specifically, insertion catheter 50 has a receiving portion or anchor receptacle 52 within which septal anchor 32 may be positioned. Anchor receptacle 52 supports septal anchor 32 when the anchor is placed therein. Release wire 31 a, or in some embodiments the guidewire, is inserted through a lumen of insertion catheter 50 and through the axial lumen of septal anchor 32 when septal anchor 32 is positioned within anchor receptacle 52. Release wire 31 a is further inserted through a lumen of a distal most portion of insertion catheter 50 (i.e., a portion positioned distally of anchor receptacle 52 and septal anchor 32) and may extend distally beyond insertion catheter 50 as shown in FIG. 10L. In this manner, septal anchor 32 may be “locked” in place within anchor receptacle 52 as shown in FIG. 10L. Insertion catheter 50 and septal anchor 32 may be advanced over the guidewire together via guidance member 80, or in some other manner. In one embodiment, insertion catheter 50 and septal anchor 32 may be advanced over the guidewire by inserting the guidewire through the lumen of insertion catheter 50 and the axial lumen of septal anchor 32. When septal anchor 32 is positioned within the right ventricle RV or any other desired area, the release wire 31 a is proximally retracted through the anchor receptacle 52 to “unlock” septal anchor 32 from the insertion catheter 50 and allow septal anchor 32 to freely rotate about tether 33. Tether 33 is typically aligned axially with insertion catheter 50 and advanced distally thereof.
FIGS. 10M & 10N illustrate guidance member or catheter 80 being coupled with a distal end 37 of tether 33. Specifically, FIG. 10M shows an enlarged view of the distal end 37 of tether 33 and a proximal end 82 of guidance member 80 axially aligned and separated from one another. The proximal end 82 of guidance member 80 is axially aligned with tether 33 and subsequently coupled with the distal end 37 of tether 33. In one embodiment, the proximal end 82 of guidance member 80 includes internal threads, or a cap having internal threads, which may be threaded onto the distal end 37 of tether 33. The threads lock or hold the coupled members in place. In another embodiment, the proximal end 82 of guidance member 80 may include a hollow portion that is press fit or snapped onto the distal end 37 of tether 33. In other embodiments, the proximal end 82 of guidance member 80 is inserted or threaded within the distal end 37 of tether 33. Various other means of coupling the opposing ends of the two members may also be used.
FIG. 10N shows tether 33 coupled with guidance member 80 by the distal end 37 being threaded within the proximal end or cap 82 of guidance member. Once coupled, tether 33 is axially aligned with guidance member 80. In this configuration, guidance member 80 simplifies insertion and positioning of tether 33 and septal anchor 32 within the heart. As described herein, the septal anchor system (i.e., tether 33 and septal anchor 32) are often inserted into the body with the tether 33 inserted first and advanced distally of septal anchor 32. The guidance member 80 improves the insertability of the tether 33 since the guidance member is axially aligned and coupled directly with tether 33. Further, as shown in FIG. 10N, a distal portion 84 of guidance member 80 includes a lumen through which guidewire 31 is inserted, which allows guidance member 80 to be inserted over the guidewire 31 and through the heart. A distal end of guidance member 80 may be tapered to ease insertion of guidance member 80 through the heart. In some embodiments, the lumen of guidance member 80 through which guidewire 31 is inserted may be configured to fit tightly around guidewire 31 to allow the guidance member 80 to be pulled through the body by pulling guidewire 31. In other embodiments, the lumen of guidance member 80 may slide freely along guidewire 31 so that the guidewire may remain relatively in place as the guidance member 80, tether 33, and/or septal anchor 32 are passed over the guidewire 31.
The guidance member 80 and tether 33 may be advanced over guidewire 31 into right ventricle RV and/or adjacent septum SE. By continuing to push tether 33 and/or by pulling guidewire 31 from the end extending from the epicardial path, guidance member 80 and tether 33 may be advanced into and through the septum SE and external wall EW so that guidance member 80 and distal end 37 of tether 33 are disposed outside the heart and the patient. Guidance member 80 and tether 33 may be advanced over guidewire 31 and ahead of septal anchor 32 so that tether 33 extends from adjacent septum SE, through left ventricle LV, to outside the patient body as shown in FIG. 9. Release wire 31 a may then be proximally retracted so that septal anchor 32 may be unlocked from anchor receptacle 52 and able to rotate relative to tether 33. Insertion catheter 50 may then be removed. An epicardial anchor 35 may then be coupled with tether 33 and advanced adjacent external wall EW, a force may be applied between epicardial anchor 35 and tether 33, and epicardial anchor 35 may be secured relative to tether 33 and septal anchor 32 as described herein. In some embodiments, insertion catheter 50 may be inserted within a hemostasis valve (e.g., 29) of another catheter (e.g., 30).
Referring now to FIGS. 16A-16D, an epicardial access tool may facilitate both access to the epicardium and hemostasis of the epicardial access path. A shaft of the epicardial access tool extends from a proximal handle to a circumferential series of distal radial compression features. A working lumen of the access tool shaft allows the various access tools to be advanced along a tissue tract from outside the patient to an epicardial surface region encompassing the epicardial access path. The compression features are oriented to engage tissue of the external wall and urge the engaged tissue radially inwardly when the handle is actuated. In the exemplary embodiment, filaments extend axially from the handle along the shaft to each compression feature, and then turn laterally from that compression feature to another compression feature. Actuation of the handle pulls the filaments, thereby pulling the compression features radially inwardly.
Referring now to FIGS. 19A-19D, a variety of minimally alternative anchor locking structures and access methods may be employed to decrease collateral tissue trauma when applying the controlled anchoring force. Such minimally invasive anchor locks may benefit from a tissue-engagement component that distributes anchoring loads laterally between anchors so as to promote apposition of the walls of the heart along a desired contour and help provide the desired ventricular shape after implantation of a multi-anchor implant system. Toward that end, a folding anchor component 1911 may comprise an at least substantially rigid elongate body having a passage traversing therethrough, with a channel extending along opposing surfaces of the body from the aperture. One of the channels may optionally extend through the body, allowing the body to be advanced laterally over tether 1916 so that the tether extends through the body at the passage. Other embodiments may employ passages in the form of apertures, so that the tether 1916 is passed axially through the passage. Regardless, the channels receive the tether 1916 so that the anchor component 1911 can pivot toward axial alignment with tether 1916, allowing the anchor component to be advanced over tether 1916 through a working lumen of an access tool or sheath 1913, as shown in FIG. 19B. Once anchor component 1911 is distal of sheath 1913 and proximal of the epicardial surface of the heart H, the anchor component 1911 can be pivoted relative to tether 1916 and slid distally along tether 1916 into engagement with the epicardial surface of heart H, as shown in FIGS. 19C and 19D. A relatively small profile (as compared to the pivoted anchor component 1911) locking anchor component, such as epicardial anchor 355, can then be advanced axially over tether 1916 through sheath 1913 and into engagement with the anchor component 1911 so as to provide the desired anchoring force. Anchor component 1911 may comprise a metal or high-strength polymer structure, such as a stainless steel, a Nitinol shape memory alloy, PEEK, or the like.
1. A method for treating a heart of a patient comprising:
inserting a guidewire through a wall of the heart;
inserting a delivery catheter over the guidewire and into the heart, the delivery catheter comprising a first end, a second end, and a lumen extending between the first end and the second end through which the guidewire is inserted;
inserting an anchor over the guidewire via the delivery catheter to a position within a chamber of the heart, the anchor being coupled with a tension member and being operationally coupled with the guidewire so as to maintain the anchor in a low profile configuration with the anchor axially aligned with the delivery catheter as the anchor is inserted within the chamber;
deploying the anchor within the chamber by removing the guidewire to enable the anchor to reorient to a deployed configuration within the chamber of the heart; and
applying tension to the anchor via the tension member so as to urge the wall against a second wall of the heart.
2. The method of claim 1, wherein the anchor has a lumen extending along an axis of an elongate structure, and wherein inserting the anchor into the heart comprises advancing the anchor structure axially over the guidewire and into the chamber so that the guidewire inhibits injury to tissue structures along or within the chamber by the anchor.
3. The method of claim 1, further comprising inserting a dilating catheter through the wall prior to inserting the delivery catheter to dilate an aperture of the wall as the dilating catheter is inserted therethrough.
4. The method of claim 3, wherein the dilating catheter comprises a tapering threaded tip that contacts tissue of the wall, and wherein the method further comprises rotating the dilating catheter about a thread axis so that the tapering threaded tip dilates the aperture.
5. The method of claim 3, wherein the dilating catheter comprises a cutting element disposed toward a distal end of the dilating catheter that cuts tissue of the wall to dilate the aperture.
6. The method of claim 3, wherein the dilating catheter comprises a lumen extending between a first end and a second end, the dilating catheter being insertable over the guidewire through the wall along an arcuate path by inserting the guidewire through the lumen.
7. The method of claim 1, further comprising inserting a pusher tube through the lumen of the delivery catheter to push the anchor through the lumen of the delivery catheter.
8. The method of claim 7, wherein the pusher tube comprises a first lumen through which the tension member is inserted and a second lumen through which the guidewire is inserted.
9. The method of claim 8, wherein the anchor is pivotally coupled with the tension member and wherein the anchor comprises a first end, a second end, and a lumen extending between the first end to the second end, and wherein operationally coupling the guidewire with the anchor comprises inserting the guidewire through the lumen of the anchor to orient the anchor relative to the second lumen of the pusher tube as the anchor is inserted through the lumen of the delivery catheter.
10. The method of claim 9, further comprising withdrawing the guidewire from the lumen of the anchor after the anchor is positioned within the chamber so that the anchor pivots from a low profile configuration to a deployed configuration.
11. The method of claim 1, further comprising withdrawing the guidewire through a lumen of the anchor and the lumen of the delivery catheter after the anchor is positioned within the chamber such that the anchor is unlocked from a receptacle of the delivery catheter and able to pivot from a low profile configuration to a deployed configuration.
axially aligning the tension member with a guidance member;
coupling a proximal end of the guidance member with a distal end of the tension member; and
inserting the guidance member and tension member over the guidewire by inserting the guidewire through a lumen of a distal portion of the guidance member, the guidance member and tension member being advanced distally of the anchor.
positioning a second anchor adjacent the second wall; and
applying tension to the anchor and the second anchor so as to urge the wall against the second wall.
expanding a laterally deployable member of the delivery catheter adjacent the wall; and
engaging the laterally deployable member of the delivery catheter against the wall so as to urge the wall toward the second wall.
15. The method of claim 14, wherein the laterally deployable member comprises one or more selected from the group consisting of: a balloon, a malecot, and a plurality of deployable arms.
16. A method for treating a heart of a patient, the heart comprising a chamber bordered by a wall, the method comprising:
inserting a guidewire into the chamber so that the inserted guidewire traverses the wall through an aperture in the wall;
inserting a dilating catheter over the guidewire to a position adjacent the wall, the dilating catheter comprising a tapering threaded tip having a thread axis;
rotating the dilating catheter about the thread axis as the dilating catheter is inserted through the wall so that the tapering threaded tip contacts tissue of the wall and rotational engagement between the tapering threaded tip and the tissue dilates the aperture of the wall to an expanded aperture;
inserting a delivery catheter over the guidewire and through the expanded aperture, the delivery catheter comprising a lumen through which the guidewire is inserted:
inserting an anchor over the guidewire and through the lumen of the delivery catheter, the anchor being coupled with a tension member and operationally coupled with the guidewire in a low profile configuration that enables insertion of the anchor through the expanded aperture;
reorienting the anchor within the chamber from the low profile configuration to a deployed configuration by removing the guidewire; and
applying tension to the anchor via the tension member.
applying tension to the anchor via the tension member so as to urge a septum wall of the heart against a chamber wall of the heart.
18. The method of claim 17, wherein the anchor and tension member are advanced adjacent the wall while the heart is beating and with the anchor axially affixed to the tension member in a low profile configuration, and wherein the anchor is deployed laterally relative to the tension member.
19. The method of claim 17, wherein the anchor is pivotally coupled with the tension member, and wherein the anchor comprises an elongate shaft having an axial lumen through which the guidewire is inserted, wherein the guidewire maintains an axial orientation of the anchor extending along the tension member while the anchor is advanced through the lumen of the delivery catheter.
coupling an additional anchor with the tension member;
positioning the additional anchor adjacent the chamber wall; and
applying tension to the anchor and additional anchor via the tension member so as to urge the septum wall against the chamber wall.
21. The method of claim 20, wherein the additional anchor comprises a variable force mode that allows the additional anchor to slide axially proximally and distally along the tension member and comprises a set force mode that inhibits either proximal or distal movement of the additional anchor along the tension member.
22. The method of claim 20, wherein applying tension to the anchor and additional anchor comprises applying a preselected amount of tension with a tension device, the tension device providing an indication of the amount of tension applied.
23. The method of claim 22, wherein applying a preselected amount of tension comprises applying a tension force between about 2 Newtons and about 6 Newtons.
24. The method of claim 22, wherein the tension device comprises a first end, a second end, and a lumen extending from the first end to the second end through which the tension member is inserted.
25. The method of claim 22, wherein applying a preselected amount of tension comprises applying a tension force between about 3 Newtons and about 4 Newtons.
26. The method of claim 25, wherein the tension device is further configured such that the applied tension force cannot exceed 4 Newtons.
27. A method for treating a heart of a patient, the heart comprising a chamber bordered by a septum, the method comprising:
inserting a guidewire into the chamber so that the inserted guidewire traverses a wall of the septum through an aperture in the septum wall;
inserting a dilating catheter over the guidewire to a position adjacent the septum wall, the dilating catheter comprising a tapering threaded distal tip having a thread axis;
rotating the dilating catheter about the thread axis as the dilating catheter is inserted through the septum wall so that the tapering threaded tip contacts tissue and rotational engagement between the tapering threaded tip and the tissue dilates the aperture of the septum wall to an expanded aperture;
inserting a delivery catheter through the expanded aperture of the septum wall;
inserting an anchor over the guidewire and through a lumen of the delivery catheter to a position distally of the septum wall, the anchor being coupled with a tension member and being operationally coupled with the guidewire in a low profile configuration that enables insertion of the anchor through the lumen of the delivery catheter, the anchor being deployable to a deployed configuration within the chamber upon removal of the guidewire; and
applying tension to the anchor via the tension member so as to urge the septum wall of the heart against a chamber wall of the heart.
US13632108 2011-09-30 2012-09-30 Over-the-wire cardiac implant delivery system for treatment of CHF and other conditions Active 2033-07-29 US9173712B2 (en)
US13632108 US9173712B2 (en) 2011-09-30 2012-09-30 Over-the-wire cardiac implant delivery system for treatment of CHF and other conditions
US14930608 US20160095600A1 (en) 2011-09-30 2015-11-02 Over-the-wire cardiac implant delivery system for treatment of chf and other conditions
US14930608 Division US20160095600A1 (en) 2011-09-30 2015-11-02 Over-the-wire cardiac implant delivery system for treatment of chf and other conditions
US20130096579A1 true US20130096579A1 (en) 2013-04-18
US9173712B2 true US9173712B2 (en) 2015-11-03
US9937043B2 (en) 2015-07-31 2018-04-10 Bioventrix, Inc. Remote pericardial hemostasis for ventricular access and reconstruction or other organ therapies
US20020077655A1 (en) * 2000-11-03 2002-06-20 Giulio Frova Tracheostomy dilator
US7431691B1 (en) * 2000-10-04 2008-10-07 Wilk Peter J Method and device for improving cardiac function
US8491455B2 (en) * 2007-10-03 2013-07-23 Bioventrix, Inc. Treating dysfunctional cardiac tissue
U.S Appl. No. 13/632,103, filed Sep. 20th, 2012, Non final Office Action mailed Aug. 27th, 2014.
US9320513B2 (en) 2016-04-26 grant
US20050107812A1 (en) 2005-05-19 Delivery devices and methods for heart valve repair
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ANNEST, LON;SHELDON, MURRAY;VAN BLADEL, KEVIN;AND OTHERS;SIGNING DATES FROM 20121218 TO 20130227;REEL/FRAME:029988/0708