Apical connectors and instruments for use in a heart wall

The present disclosure provides an apical connector for use in a heart wall. The apical connector may include a port defining an aperture therethrough, an anchoring device extending distally from the port and configured for advancing at least partially through the heart wall, and a cannula configured for advancing through the aperture of the port and at least partially through the heart wall. The cannula may include a locking tab configured to engage the port and lock the cannula with respect to the port.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to devices, systems, and methods for implanting and using a connector in a tissue wall to establish, maintain, control, and close a fluid communication between opposing surfaces of the tissue wall. In particular, the present disclosure relates to apical connectors and instruments for use in a heart wall to facilitate in vivo implantation of a ventricular assist device and its attachment to the heart.

BACKGROUND OF THE DISCLOSURE

Mechanical circulatory support (MCS) systems assist the heart in circulating blood in the body. A ventricular assist device (VAD) is an example of an MCS system that is used to assist one or both ventricles of the heart to circulate blood. For patients suffering from heart failure, assisting the left ventricle of the heart via a left ventricular assist device (LVAD) extending between the left ventricle and the aorta is more common, although the right ventricle may be assisted via a right ventricular assist device (RVAD) extending between the right ventricle and the pulmonary artery. Two VADs can also be used in a BiVAD configuration. Currently, VADs are commonly used for destination therapy or as a bridge to transplant option for patients with heart failure.

According to current techniques for LVAD implantation, which typically are performed on-pump (i.e., employing cardiopulmonary bypass), a hole is formed in the heart wall, typically at or near the apex of the left ventricle, and a connector or conduit is secured within or about the hole. RVAD implantation techniques, which also tend to be performed on-pump, involve forming a hole in the lateral wall of the right ventricle and securing a connector or conduit within or about the hole. After establishing a fluid tight connection between the conduit and the ventricular wall, an inlet tube of the VAD is attached to the connector or conduit, which allows blood to flow from the ventricle to a pump of the VAD. Due to the substantial risks of cardiopulmonary bypass, particularly for patients with advanced heart failure, it would be highly desirable to implant the VAD during an off-pump procedure. However, due to challenges in forming a hole in the ventricle of an active heart, reliably securing the connector or conduit in the heart wall, and reliably attaching the inlet tube of the VAD to the connector or conduit, on-pump techniques remain common for VAD implantation.

Various connectors and instruments have been developed for use in a heart wall to facilitate in vivo implantation of a VAD and its attachment to the heart. However, improved connectors, instruments, and related methods are desired for quickly, safely, and reliably implanting a VAD without the use of cardiopulmonary bypass while minimizing blood loss.

SUMMARY OF THE DISCLOSURE

Various embodiments of the present disclosure provide improved connectors, instruments, and related methods for quickly, safely, and reliably implanting a VAD in a manner that eliminates or reduces the need for cardiopulmonary bypass while also minimizing blood loss. In one aspect, an apical connector is provided for use in a heart wall. The apical connector may include a port defining an aperture therethrough, an anchoring device extending distally from the port and configured for advancing at least partially through the heart wall, and a cannula configured for advancing through the aperture of the port and at least partially through the heart wall. The cannula may include a locking tab configured to engage the port and lock the cannula with respect to the port.

In another aspect, an apical connector is provided for use in a heart wall. The apical connector may include a port defining an aperture therethrough, and an anchoring device extending distally from the port and configured for advancing at least partially through the heart wall. The anchoring device may include a plurality of coils offset from one another and arranged in a generally symmetric manner about a central axis of the apical connector such that the coils follow separate helical paths in the heart wall.

In still another aspect, an apical connector is provided for use in a heart wall. The apical connector may include a port defining an aperture therethrough, a sewing ring extending radially outward from the port and configured for suturing to the heart wall, and an anchoring device extending distally from the port and configured for advancing at least partially through the heart wall. The anchoring device may include a coil.

These and other features and improvements of embodiments of the present disclosure will be apparent or will become apparent to one of ordinary skill in the art upon review of the following detailed description when taken in conjunction with the several drawings and the appended claims.

DETAILED DESCRIPTION OF THE DISCLOSURE

Various embodiments of the present disclosure provide improved connectors, instruments, and related methods for quickly, safely, and reliably implanting a VAD in a manner that eliminates or reduces the need for cardiopulmonary bypass while also minimizing blood loss. Various aspects of the devices, instruments, and methods disclosed herein build upon those described in the following patent applications, which are incorporated by reference herein in their entirety for all purposes: PCT Application No. PCT/US2015/019308, filed Mar. 6, 2015; PCT Application No. PCT/US2014/028346, filed Mar. 14, 2014; PCT Application No. PCT/US2014/021389, filed Mar. 6, 2014; PCT Application No. PCT/US2013/056952, filed Aug. 28, 2013; U.S. Provisional Application No. 62/127,262, filed Mar. 2, 2015; U.S. Provisional Application No. 61/949,113, filed Mar. 6, 2014; U.S. Provisional Application No. 61/865,908, filed Aug. 14, 2013; U.S. Provisional Application No. 61/859,608, filed Jul. 29, 2013; U.S. Provisional Application No. 61/842,810, filed Jul. 3, 2013; U.S. Provisional Application No. 61/793,643, filed Mar. 15, 2013; U.S. application Ser. No. 13/842,578, filed Mar. 15, 2013; U.S. application Ser. No. 13/410,670, filed Mar. 2, 2012; U.S. application Ser. No. 13/035,837, filed Feb. 25, 2011; U.S. application Ser. No. 12/945,890, filed Nov. 14, 2010; U.S. application Ser. No. 12/590,864, filed Nov. 15, 2009; and U.S. application Ser. No. 12/590,863, filed Nov. 15, 2009. As will be appreciated by one of ordinary skill in the art, identical or similar terminology may be used herein to describe connectors, instruments, methods, structural features, and functional aspects similar to those described in these applications. Moreover, certain similarities will be apparent upon comparison of the drawings of the present disclosure and those of these applications, even though different terminology may be used.

Embodiments of the present disclosure are described herein below with reference to the accompanying drawings, in which some, but not all, embodiments are shown. Indeed, the connectors, instruments, and methods disclosed may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure is thorough and complete and fully conveys the scope of the connectors, instruments, and methods to those skilled in the art. Like reference numbers refer to like elements throughout. The singular forms “a,” “an,” and “the” can refer to plural instances unless the context clearly dictates otherwise or unless explicitly stated.

The embodiments of the present disclosure provide improved connectors, instruments, and related methods for quickly, safely, and reliably implanting a VAD. Various aspects of the embodiments allow the VAD to be implanted in a manner that eliminates or reduces the need for cardiopulmonary bypass. Various aspects of the embodiments allow the VAD to be implanted while minimizing blood loss. Although the disclosed connectors and instruments are particularly advantageous for implanting a VAD in a heart wall, it will be appreciated that the connectors and instruments alternatively may be used in other tissue walls of the body for other procedures to provide similar benefits including, but not limited to, valve replacement and repair. Such alternative uses are described in part in the applications listed above.

In one aspect, an apical connector is provided for use in a heart wall. The apical connector may include a port defining an aperture therethrough, an anchoring device extending distally from the port and configured for advancing at least partially through the heart wall, and a cannula configured for advancing through the aperture of the port and at least partially through the heart wall. The cannula may include a locking tab configured to engage the port and lock the cannula with respect to the port.

In some embodiments, the locking tab may be offset from a proximal end of the cannula and may extend along an outer circumferential surface of the cannula. In some embodiments, the cannula may further include a partial flange, and the locking tab may extend from the partial flange. In some embodiments, the locking tab may be configured to deflect from a natural position to a biased position with respect to the partial flange. In some embodiments, the port may include a recess defined in a proximal end of the port and configured to receive the locking tab and the partial flange of the cannula. In some embodiments, the port may further include an undercut groove in communication with the recess and configured to receive the locking tab and the partial flange of the cannula upon rotation of the cannula with respect to the port. In some embodiments, the port may further include a locking protrusion configured to deflect the locking tab of the cannula from the natural position to the biased position upon rotation of the cannula with respect to the port in a first direction.

In some embodiments, the cannula may further include an elastomer covering molded over a proximal portion of the cannula. In some embodiments, the cannula may further include a plurality of engagement recesses defined in a proximal end of the cannula, and the elastomer covering may extend partially over each of the engagement recesses. In some embodiments, the anchoring device may include a plurality of coils offset from one another and arranged in a generally symmetric manner about a central axis of the apical connector such that the coils follow separate helical paths in the heart wall. In some embodiments, the apical connector my further include a sewing ring extending radially outward from the port and configured for suturing to the heart wall. In some embodiments, the apical connector my further include a valve positioned within the cannula and configured for controlling fluid communication therethrough.

In another aspect, an apical connector is provided for use in a heart wall. The apical connector may include a port defining an aperture therethrough, and an anchoring device extending distally from the port and configured for advancing at least partially through the heart wall. The anchoring device may include a plurality of coils offset from one another and arranged in a generally symmetric manner about a central axis of the apical connector such that the coils follow separate helical paths in the heart wall.

In some embodiments, distal ends of the coils may be equally spaced apart from one another in a circumferential direction with respect to the central axis of the apical connector. In some embodiments, each of the coils may be attached to the port at an attachment point, and the attachments points may be equally spaced apart from one another in a circumferential direction with respect to the central axis of the apical connector. In some embodiments, the plurality of coils may include two coils, and distal ends of the two coils may be spaced apart from one another by approximately 180 degrees in a circumferential direction with respect to the central axis of the apical connector. In some embodiments, each of the two coils may be attached to the port at an attachment point, and the attachments points may be spaced apart from one another by approximately 180 degrees in a circumferential direction with respect to the central axis of the apical connector. In some embodiments, each of the coils may have a radially expanding shape such that a helical diameter of the coil increases from a proximal end to a distal end of the coil.

In still another aspect, an apical connector is provided for use in a heart wall. The apical connector may include a port defining an aperture therethrough, a sewing ring extending radially outward from the port and configured for suturing to the heart wall, and an anchoring device extending distally from the port and configured for advancing at least partially through the heart wall. The anchoring device may include a coil.

In another aspect, an apical connector is provided for use in a heart wall. The apical connector may include a port defining an aperture therethrough, a primary anchoring device extending distally from the port and configured for advancing at least partially through the heart wall, and a secondary anchoring device configured for advancing at least partially through the heart wall. At least a portion of the secondary anchoring device may be positioned radially outward from the primary anchoring device.

In some embodiments, the primary anchoring device may include a coil. In some embodiments, the primary anchoring device may be rigidly attached to the port. In some embodiments, the secondary anchoring device may include one or more tissue anchors configured to extend through mating apertures defined in the port. In some embodiments, the one or more tissue anchors may include one or more coils. In some embodiments, the one or more tissue anchors may include one or more pins, prongs, barbs, hooks, or staples. In some embodiments, the secondary anchoring device may include a collar and one or more tissue anchors attached to the collar. In some embodiments, the one or more tissue anchors may include one or more partial coils. In some embodiments, the collar may be configured to attach to the port. In some embodiments, the collar may include a tab, and the port may include a groove configured to receive the tab.

In still another aspect, an apical connector is provided for use in a heart wall. The apical connector may include a port defining an aperture therethrough, an anchoring device extending distally from the port and configured for advancing at least partially through the heart wall, and a cannula configured for advancing through the aperture of the port and at least partially through the heart wall. The cannula may include a plurality of tabs configured to engage the port and lock the cannula with respect to the port.

In some embodiments, the tabs may be arranged in a circumferential array along an outer circumferential surface of the cannula. In some embodiments, the port may include a pawl configured to selectively engage the tabs of the cannula. In some embodiments, the pawl may be configured to deflect away from a natural position when the pawl engages the tabs of the cannula such that the pawl and the tabs form a ratchet mechanism. In some embodiments, the cannula may include male threads, and the port may include female threads configured to engage the male threads of the cannula.

In another aspect, an instrument is provided for coring a hole in a heart wall and attaching a cannula to a port of an apical connector. The instrument may include a main handle, a shaft attached to the main handle, an anvil movably attached to the shaft and configured to move from an insertion position to a coring position, a coring handle positioned over at least a portion of the shaft, a cannula interface attached to the coring handle and configured for removably attaching to the cannula of the apical connector, and a coring tube attached to the coring handle and configured for coring the hole in the heart wall. The coring handle may be configured to translate and rotate with respect to the main handle.

In some embodiments, the coring tube may extend distally beyond the cannula interface. In some embodiments, the cannula interface may be rigidly attached to the coring handle. In some embodiments, the coring tube may be rigidly attached to the coring handle. In some embodiments, the main handle may include a plurality of indicators that correspond to a distance between a distal end of the coring tube and a proximal end of the anvil.

In still another aspect, an instrument is provided for coring a hole in a heart wall and attaching a cannula to a port of an apical connector. The instrument may include a handle, a cannula interface attached to the handle and configured for removably attaching to the cannula of the apical connector, a coring tube rigidly attached to the handle and configured for coring the hole in the heart wall, and a coring anchor rigidly attached to the handle and configured for providing counter-traction for advancing the coring tube into the heart wall.

In some embodiments, the coring anchor may include a coil configured for advancing at least partially through the heart wall. In some embodiments, the coring anchor may extend distally beyond the coring tube. In some embodiments, the coring tube may extend distally beyond the cannula interface. In some embodiments, the cannula interface may be rigidly attached to the handle.

In another aspect, instrument system is provided for securing a port of an apical connector to a heart wall, coring a hole in the heart wall, and attaching a cannula to the port of the apical connector. The instrument system may include a centering guide configured for attaching to the heart wall, a first instrument configured for advancing over the centering guide to secure the port of the apical connector to the heart wall, and a second instrument configured for advancing over the centering guide to core the hole in the heart wall and attach the cannula to the port of the apical connector.

In some embodiments, the centering guide may include a handle, and a guide anchor attached to the handle and configured for attaching the centering guide to the heart wall. In some embodiments, the guide anchor may include a coil configured for advancing at least partially through the heart wall. In some embodiments, the first instrument may include a handle, and a port interface attached to the handle and configured for removably attaching to the port of the apical connector. In some embodiments, the second instrument may include a handle, a cannula interface attached to the handle and configured for removably attaching to the cannula of the apical connector, and a coring tube attached to the handle and configured for coring the hole in the heart wall.

In still another aspect, an instrument is provided for coring a hole in a heart wall and attaching a cannula to a port of an apical connector. The instrument may include a handle, a shaft attached to the handle and extending distally therefrom, a coring anchor attached to the shaft and extending distally therefrom, a coring sleeve movably positioned over at least a portion of the shaft, a coring tube attached to the coring sleeve and extending distally therefrom, an attachment sleeve movably positioned over at least a portion of the coring sleeve, and a cannula interface attached to the attachment sleeve and extending distally therefrom.

In some embodiments, the coring anchor may include a coil configured for advancing at least partially through the heart wall. In some embodiments, the shaft may be rigidly attached to the handle, the coring anchor may be rigidly attached to the shaft, the coring tube may be rigidly attached to the coring sleeve, and the cannula interface may be rigidly attached to the attachment sleeve. In some embodiments, the instrument may be adjustable between a first configuration and a second configuration, the coring sleeve and the attachment sleeve may be configured to rotate with the handle when the instrument is in the first configuration, and the coring sleeve and the attachment sleeve may be configured to rotate relative to the handle when the instrument is in the second configuration. In some embodiments, the instrument may further include a button configured to selectively maintain the instrument in the first configuration.

In another aspect, an instrument is provided for coring a hole in a heart wall and attaching a cannula to a port of an apical connector. The instrument may include a handle, a shaft attached to the handle and extending distally therefrom, a coring anchor attached to the shaft and extending distally therefrom, a sleeve movably positioned over at least a portion of the shaft, a cannula interface attached to the sleeve and extending distally therefrom, and a coring tube attached to the sleeve and extending distally therefrom.

In some embodiments, the coring anchor may include a coil configured for advancing at least partially through the heart wall. In some embodiments, the shaft may be rigidly attached to the handle, the coring anchor may be rigidly attached to the shaft, and the coring tube may be rigidly attached to the attachment sleeve. In some embodiments, the instrument may be adjustable between a first configuration and a second configuration, the sleeve may be configured to rotate with the handle when the instrument is in the first configuration, and the sleeve may be configured to translate and rotate relative to the handle when the instrument is in the second configuration. In some embodiments, the instrument may further include a button configured to selectively maintain the instrument in the first configuration.

In still another aspect, an instrument system is provided for securing a port of an apical connector to a heart wall, coring a hole in the heart wall, and attaching a cannula to the port of the apical connector. The instrument system may include a first instrument configured to secure the port of the apical connector to the heart wall, and a second instrument configured for advancing through the first instrument to core the hole in the heart wall and attach the cannula to the port of the apical connector.

In some embodiments, the first instrument may include a handle, and a port interface attached to the handle and configured for removably attaching to the port of the apical connector. In some embodiments, the second instrument may include a handle, a shaft attached to the handle, a coring anchor attached to the shaft and configured for coring the hole in the heart wall, a sleeve movably positioned over at least a portion of the shaft, a cannula interface attached to the sleeve and configured for removably attaching to the cannula of the apical connector, and a coring anchor attached to the sleeve and configured for providing counter-traction for advancing the coring tube into the heart wall. In some embodiments, the second instrument may be adjustable between a first configuration and a second configuration, the sleeve may be configured to rotate with the handle when the second instrument is in the first configuration, and the sleeve may be configured to translate and rotate relative to the handle when the second instrument is in the second configuration. In some embodiments, the second instrument may further include a button configured to selectively maintain the second instrument in the first configuration.

In another aspect, an instrument is provided for stabilizing an apical connector secured in a heart wall. The instrument may include a handle, and a connector interface attached to a distal end of the handle. The connector interface may include a pair of prongs defining an opening configured for receiving a portion of the connector therebetween, and a protrusion configured for engaging a mating engagement feature of the connector.

In some embodiments, the prongs may have a C-shaped configuration for receiving the portion of the connector therebetween. In some embodiments, the protrusion may be positioned about an intersection of the prongs. In some embodiments, the protrusion may be aligned with a center of the connector interface. In some embodiments, one or more portions of the instrument may be formed of a pliable material.

In still another aspect, an instrument is provided for allowing inspection of a ventricle of a heart through an apical connector secured in a heart wall. The instrument may include a tube defining an aperture therethrough, the tube configured for inserting at least partially through the apical connector and at least partially through the heart wall, and a proximal flange attached to the tube, the proximal flange configured for abutting a proximal end of the apical connector.

In another aspect, a method is provided for inspecting a ventricle of a heart through an apical connector secured in a heart wall, the apical connector including a cannula and a valve disposed within the cannula. The method may include the steps of opening the valve of the apical connector, and inspecting the ventricle through the cannula of the apical connector.

In some embodiments, the step of opening the valve of the apical connector may include inserting an instrument at least partially within the cannula. In some embodiments, the instrument may include a tube defining an aperture therethrough, and a proximal flange attached to the tube. In some embodiments, the step of inserting the instrument at least partially within the cannula may include inserting the tube at least partially within the cannula. In some embodiments, the step of inspecting the ventricle through the cannula of the apical connector may include inspecting the ventricle through the tube.

Apical Connectors

PCT Application No. PCT/US2014/028346 (the '346 Application) describes various embodiments of a connector configured for implanting and using in a tissue wall to establish, maintain, control, and close a fluid communication between opposing surfaces of the tissue wall. As described, the connector specifically may be used as an apical connector in a heart wall at or near the apex of the left ventricle to facilitate in vivo implantation of a VAD and its attachment to the heart. According to certain embodiments, the connector may include an anchoring device, a port, and a coupler device, as described in the '346 Application. The anchoring device may be configured for advancing at least partially into the heart wall to secure the connector thereto for subsequent implantation of the VAD. The port may be attached to a proximal end of the anchoring device and may define an aperture therethrough. In this manner, upon advancing a distal end of the anchoring device at least partially into the heart wall, the port may be positioned against the heart wall such that the aperture provides access to the heart wall. The coupler device may be positioned about or integrated into the port and may be configured for coupling an inlet tube of the VAD to the connector after positioning the inlet tube at least partially through the heart wall and in communication with the ventricle. In certain embodiments, such as those described with respect to FIGS. 4A-4I of the '346 Application, the connector also may include a cannula having a hemostasis valve configured for controlling blood flow through the connector during the VAD implantation procedure.

Referring now to the drawings of the present disclosure,FIG. 1illustrates an embodiment of a portion of an apical connector100(which also may be referred to as a “heart connector” or a “tissue connector”) configured for securing in a heart wall (which also may be referred to as a “tissue wall”) to facilitate in vivo implantation of a VAD and its attachment to the heart. The connector100may include an anchoring device102and a port106attached to the anchoring device102, as shown, which features may correspond generally to those described with respect to the various embodiments of the '346 Application, although certain differences are described herein below. It will be appreciated that the connector100also may include other features, such as a coupler device and/or a cannula having a hemostasis valve, configured in a manner similar to those described with respect to the various embodiments of the '346 Application. For example, the connector100may include the cannula470described below.

The anchoring device102may include a plurality of helical coils103positioned about a central axis ACof the connector100and configured for advancing at least partially into the heart wall along respective helical paths defined by the coils103. For example, as shown inFIG. 1, the anchoring device102may include two coils103that are offset from one another and arranged in a generally symmetric manner about the central axis ACof the connector100. In particular, the two coils103may be attached to the port106at attachment points that are spaced apart from one another, for example, by 180-degrees in a circumferential direction with respect to the central axis ACof the connector100. The tips (i.e., the distal ends) of the two coils103also may be spaced apart from one another, for example, by 180-degrees in a circumferential direction with respect to the central axis ACof the connector100. In this manner, the two coils103may follow separate, opposing helical paths in the myocardial wall. In other embodiments, the anchoring device102may include three or more coils103that are offset from one another and arranged in a generally symmetric manner about the central axis ACof the connector100, such that the coils103follow separate helical paths in the myocardial wall. The three or more coils103may include attachment points and tips that are equally spaced from one another in a circumferential direction with respect to the central axis ACof the connector100. In various embodiments, the anchoring device102may include two or more coils103that are “clocked” (i.e., circumferentially spaced) from each other by 20 degrees, 25 degrees, 30 degrees, 45 degrees, 60 degrees, 90 degrees, or 120 degrees with respect to the central axis ACof the connector100. As shown, the coils103may have a radially-expanding helical shape (i.e., a conical shape) such that a helical diameter of the coil103increases from the proximal end to the distal end of the coil103. Due to the radially-expanding helical shape, the coils103may be configured to compress at least a portion of the heart wall inward toward the central axis ACof the connector100when the anchoring device102is advanced through the heart wall. It will be appreciated from the description herein that the anchoring device102may include other anchoring mechanisms (other than coils) common in the surgical field, such as clips, staples, and screws. In some embodiments, the anchoring device102may include a combination of different anchoring mechanisms.

As compared to embodiments in which the anchoring device102includes only a single coil103, the plurality of coils103of the foregoing embodiments may improve stability of the port106as well as the overall connector100when secured in the heart wall. In particular, the plurality of coils103may provide balanced engagement of the heart wall and prevent the port106from lifting off of the heart wall (opposite the coil insertion point), as may be experienced with a single coil configuration of the anchoring device102. As will be appreciated, the plurality of coils103may enhance initial starting and advancing of the anchoring device102in the heart wall in a manner similar to that of a multi-start threadform. Additionally, as compared to a single coil configuration, the coils103may be shorter, resulting in increased rigidity of the coils103, which may improve implantation consistency as well as full engagement feedback as the anchoring device102is secured in the heart wall. Further, the balanced engagement provided by the plurality of coils103may improve hemostasis achieved upon implantation of the connector100, for example by ensuring balanced contact between the port106and the heart wall, or between an additional sealing element of the connector100and the heart wall.

FIG. 2illustrates an embodiment of a portion of an apical connector200(which also may be referred to as a “heart connector” or a “tissue connector”) configured for securing in a heart wall (which also may be referred to as a “tissue wall”) to facilitate in vivo implantation of a VAD and its attachment to the heart. The connector200may include a primary anchoring device202and a port206attached to the primary anchoring device202, as shown, which features may correspond generally to those described with respect to the various embodiments of the '346 Application, although certain differences are described herein below. It will be appreciated that the connector200also may include other features, such as a coupler device and a cannula having a hemostasis valve, configured in a manner similar to those described with respect to the various embodiments of the '346 Application. For example, the connector200may include the cannula470described below.

The primary anchoring device202may include one or more helical coils203positioned about a central axis ACof the connector200and configured for advancing at least partially into the heart wall along a helical path defined by the one or more coils203. For example, as shown inFIG. 2, the primary anchoring device202may include a single coil203. As shown, the coil203may have a radially-expanding helical shape such that a helical diameter of the of the coil203increases from the proximal end to the distal end of the coil203. The connector200also may include a secondary anchoring device207configured for engaging the heart wall. The secondary anchoring device207may include one or more tissue anchors209configured for extending through mating apertures defined in the port206and advancing at least partially into the heart wall. As shown inFIG. 2, each tissue anchor209may include a helical coil211extending from an anchor head213and configured for advancing into the heart wall. Alternatively, each tissue anchor209may include a pin, prong, barb, hook, staple, or other similar feature extending from the anchor head213and configured for advancing into the heart wall. As shown, the one or more tissue anchors209may be positioned radially outward from the primary anchoring device202for engaging a separate portion of the heart wall as compared to the portion of the heart wall engaged by the primary anchoring device202.

As compared to embodiments including only the primary anchoring device202, the additional secondary anchoring device207may improve stability of the port206as well as the overall connector200when secured in the heart wall. In particular, the one or more tissue anchors209may provide balanced engagement of the heart wall and prevent the port206from lifting off of the heart wall, as may be experienced with a connector including only a primary anchoring device having a single coil configuration. The secondary anchoring device207may be configured as a locking mechanism, for example, to prevent the primary anchoring device202from rotating out of the tissue of the heart wall. Additionally, as compared to a connector including only a primary anchoring device having a single coil configuration, the coil203of the primary anchoring device202may be shorter, resulting in increased rigidity of the coil203, which may improve implantation consistency as well as full engagement feedback as the primary anchoring device202is secured in the heart wall. Further, the balanced engagement provided by the one or more tissue anchors209in combination with the primary anchoring device202may improve hemostasis achieved upon implantation of the connector200, for example by ensuring balanced contact between the port206and the heart wall, or between an additional sealing element of the connector200and the heart wall. It will be appreciated that the connector200may include a variety and number of anchoring devices, which may include one or more coils, clips, staples, screws, or other anchoring mechanisms. In some embodiments, the secondary anchoring device207may include one or more coils having a different configuration than one or more coils of the primary anchoring device202. For example, the one or more coils of the primary anchoring device202and the one or more coils of the secondary anchoring device207may have different pitches, coil lengths, diameters, taper angles, etc.

FIG. 3illustrates an embodiment of a portion of an apical connector300(which also may be referred to as a “heart connector” or a “tissue connector”) configured for securing in a heart wall (which also may be referred to as a “tissue wall”) to facilitate in vivo implantation of a VAD and its attachment to the heart. The connector300may include a primary anchoring device302and a port306attached to the primary anchoring device302, as shown, which features may correspond generally to those described with respect to the various embodiments of the '346 Application, although certain differences are described herein below. It will be appreciated that the connector300also may include other features, such as a coupler device and a cannula having a hemostasis valve, configured in a manner similar to those described with respect to the various embodiments of the '346 Application. For example, the connector200may include the cannula470described below.

The primary anchoring device302may include one or more helical coils303positioned about a central axis ACof the connector300and configured for advancing at least partially into the heart wall along a helical path defined by the one or more coils303. For example, as shown inFIG. 3, the primary anchoring device302may include a single coil303. As shown, the coil303may have a radially-expanding helical shape such that a helical diameter of the of the coil303increases from the proximal end to the distal end of the coil303. The connector300also may include a secondary anchoring device307configured for engaging the heart wall. The secondary anchoring device307may include one or more tissue anchors309attached to and extending from a common collar311and configured for advancing at least partially into the heart wall. Each tissue anchor309may include a partial helical coil extending from the collar311, as shown inFIG. 3. Alternatively, each tissue anchor309may include a pin, prong, barb, hook, staple, or other similar feature extending from the collar311and configured for advancing into the heart wall. As shown, the one or more tissue anchors309may be positioned radially outward from the primary anchoring device302for engaging a separate portion of the heart wall as compared to the portion of the heart wall engaged by the primary anchoring device302. In some embodiments, the collar311may be configured to attach to and lock onto the port306upon advancing the one or more tissue anchors309into the heart wall. As shown, the collar311may include one or more tabs313, and the port306may include one or more grooves315defined in an outer surface of the port306and configured to receive the one or more tabs313. Upon advancing the one or more tissue anchors309into the heart wall via rotation of the collar311, the one or more tabs313may be received within the one or more grooves315, thereby locking the collar311with respect to the port306. In this manner, the tabs313and the grooves315may form a partial-turn locking mechanism, such as a half-turn locking mechanism. Alternatively, the collar311and the port306may include mating threads or other features for attaching and locking the collar311relative to the port306.

As compared to embodiments including only the primary anchoring device302, the additional secondary anchoring device307may improve stability of the port306as well as the overall connector300when secured in the heart wall. In particular, the one or more tissue anchors309and the collar311may provide balanced engagement of the heart wall and prevent the port306from lifting off of the heart wall, as may be experienced with a connector including only a primary anchoring device having a single coil configuration. Additionally, as compared to a connector including only a primary anchoring device having a single coil configuration, the coil303of the primary anchoring device302may be shorter, resulting in increased rigidity of the coil303, which may improve implantation consistency as well as full engagement feedback as the primary anchoring device302is secured in the heart wall. Further, the balanced engagement provided by the one or more tissue anchors309and the collar311may improve hemostasis achieved upon implantation of the connector300, for example by ensuring balanced contact between the port306and the heart wall, or between an additional sealing element of the connector300and the heart wall.

FIG. 3also illustrates a delivery instrument321for securing the apical connector300in the heart wall. The delivery instrument321may include a port engaging/driving portion323(which also may be referred to as a “port interface”) attached to a shaft325and configured for engaging and driving the port306for advancing the primary anchoring device302into the heart wall. The delivery instrument321also may include a collar engaging/driving portion327(which also may be referred to as a “collar interface”) attached to a cannulated sleeve329and configured for engaging and driving the collar311for advancing the secondary anchoring device307into the heart wall in a concentric manner about the port306. The shaft325and the cannulated sleeve329may be configured to translate and rotate with respect to one another. In this manner, the shaft325and the port engaging/driving portion323may be used to advance the primary anchoring device302into the heart wall, and then the cannulated sleeve329and the collar engaging/driving portion327may be used to advance the secondary anchoring device307into the heart wall and to attach the collar311to the port306.

FIGS. 4A and 4Billustrate an embodiment of a portion of an apical connector400(which also may be referred to as a “heart connector” or a “tissue connector”) configured for securing in a heart wall (which also may be referred to as a “tissue wall”) to facilitate in vivo implantation of a VAD and its attachment to the heart. The connector400may include an anchoring device402including one or more helical coils403, a port406attached to the anchoring device402, and a cannula470having a hemostasis valve462, as shown, which features may correspond generally to those described with respect to the various embodiments of the '346 Application, although certain differences are described herein below. It will be appreciated that the connector400also may include other features, such as a coupler device, configured in a manner similar to those described with respect to the various embodiments of the '346 Application.

The cannula470may include a plurality of tabs471positioned at or near the proximal end of the cannula470and extending radially outward. In particular, the tabs471may be arranged in a circumferential array extending from the outer surface of the cannula470, as shown inFIGS. 4A and 4B. The cannula470also may include male threads472formed along the outer surface of the cannula470and positioned distally with respect to the tabs471. The port406may include one or more pawls473positioned at or near the proximal end of the port406and extending along the circumference thereof. The port406also may include female threads474formed along the inner surface of the port406and positioned distally with respect to the pawls473. The threads472of the cannula470may engage the threads474of the port406as the cannula470is inserted through the aperture of the port406and rotated with respect to the port406. The pawls473may be resilient or spring-like and configured to deflect away from a natural position when a biasing force is applied thereto via the tabs471as the cannula470threadably engages the port406. In this manner, the tabs471of the cannula470and the one or more pawls473of the port406may form a ratchet mechanism as the one or more pawls473selectively engage the tabs471. The ratchet mechanism may prevent the cannula470from being unthreaded from the port406unless the pawls473are biased by a user to disengage the tabs471.

As compared to some other connector embodiments, the ratchet mechanism of the connector400provides a means for locking the cannula470to the port406, which may improve the structural integrity of connector as well as the hemostasis achieved upon implantation of the connector400. Moreover, the ratchet mechanism provides tactile feedback as the cannula470is attached to the port406.

FIGS. 5A and 5Billustrate an embodiment of a portion of an apical connector500(which also may be referred to as a “heart connector” or a “tissue connector”) configured for securing in a heart wall (which also may be referred to as a “tissue wall”) to facilitate in vivo implantation of a VAD and its attachment to the heart. The connector500may include an anchoring device502, a port506attached to the anchoring device502, and a cannula570having a hemostasis valve562, as shown, which features may correspond generally to those described with respect to the various embodiments of the '346 Application, although certain differences are described herein below. It will be appreciated that the connector500also may include other features, such as a coupler device, configured in a manner similar to those described with respect to the various embodiments of the '346 Application.

The cannula570may include one or more locking members571positioned near the proximal end of the cannula570and extending along the outer circumference thereof. Each locking member571may extend from a partial flange573of the cannula570and may be resilient or spring-like and configured to deflect radially inward from a natural position when a biasing force is applied thereto via mating features of the port506as the cannula570is attached to the port506. The port506may include one or more recesses575defined about the proximal end of the port506and configured to allow the locking members571and the partial flanges573to be inserted axially therein. The port506also may include one or more undercut grooves577defined near the proximal end of the port506and extending along the inner circumference thereof. Each undercut groove577may be positioned adjacent to and in communication with one of the recesses575. The undercut grooves577may be configured to receive the locking members571and the partial flanges573of the cannula570upon rotation of the cannula570with respect to the port506. The port507further may include one or more locking protrusions581and one or more stop protrusions583. The locking protrusions581may be configured to deflect the locking members571of the cannula570radially inward upon rotation of the cannula570with respect to the port506in a first direction, and the stop protrusions583may be configured to contact the locking members571and limit rotation of the cannula570with respect to the port506in the first direction. The locking members571may be configured to return to their natural position after advancing past the locking protrusions581and prevent rotation of the cannula570with respect to the port506in an opposite second direction. In this manner, the mating features of the cannula570and port506may form a partial-turn locking mechanism configured to prevent the cannula570from being detached from the port506unless the locking members571are biased by a user to disengage the locking protrusions581and allow rotation of the cannula570with respect to the port506in the second direction. According to the embodiment shown inFIGS. 5A and 5B, the partial-turn locking mechanism is a half-turn locking mechanism, although other configurations are possible, such as a ⅓-turn or a ¼-turn configuration.

As compared to some other connector embodiments, the partial-turn locking mechanism of the connector500provides a means for locking the cannula570to the port506, which may improve the structural integrity of connector as well as the hemostasis achieved upon implantation of the connector500. Moreover, the partial-turn locking mechanism provides tactile feedback as the cannula570is attached to the port506.

Instruments

The applications listed above describe various embodiments of instruments and instrument systems for securing an apical connector in a heart wall, coring a hole in the heart wall, and/or attaching a cannula to a port of the apical connector. As will be appreciated, the instruments, instrument systems, and related methods disclosed herein may include structural features and functional aspects similar to those described in the applications listed above.

FIGS. 6A and 6Billustrate an embodiment of an instrument600for coring a hole in a heart wall (which also may be referred to as a “tissue wall”) and attaching a cannula to a port of an apical connector (which also may be referred to as a “heart connector” or a “tissue connector”). The instrument600may be configured for use with the apical connector400described above, including the valved cannula470and the port406, or any of the other connectors described herein or in the applications listed above.

The instrument600may include a main handle603, a shaft605rigidly attached to the main handle603and extending distally therefrom, and an anvil607movably attached to the distal end of the shaft605. The anvil607may be configured to move with respect to the shaft605from an insertion position, as shown inFIG. 6A, to a coring position, as shown inFIG. 6B. In particular, the anvil607may be attached to the distal end of the shaft605in a manner that allows the anvil607to rotate, flip, or pivot from the insertion position to the coring position. When the anvil607is in the insertion position, the anvil607may extend in line with or parallel to the longitudinal axis of the shaft605, and when the anvil607is in the coring position, the anvil607may extend perpendicular to the longitudinal axis of the shaft605. The instrument600also may include a coring handle611, a cannula interface613rigidly attached to the distal end of the coring handle611, and a coring tube615rigidly attached to the coring handle611and extending distally beyond the cannula interface613. The cannula interface613may be configured for removably attaching to and retaining a cannula of an apical connector, such as the valved cannula470of the apical connector400, as shown. The coring tube615may be configured for contacting the heart wall and coring a hole therein, as described in detail below. The coring handle611may be configured for advancing the cannula interface613(and the cannula470attached thereto) toward the port406previously attached to the heart wall via the anchoring device402, and for advancing the coring tube615toward the heart wall and through the aperture of the port406, as described in detail below. As shown, the coring tube615may be configured to extend through and distally beyond the cannula470when the cannula470is attached to the cannula interface613. When the cannula470is attached to the cannula interface613, the hemostasis valve462may assume an open position and may form a seal against the outer surface of the coring tube615.

The coring handle611, the cannula interface613, and the coring tube615may be cannulated and movably positioned over respective portions of the main handle603and the shaft605. In particular, the coring handle611, the cannula interface613, and the coring tube615may be configured to translate axially with respect to the main handle603, the shaft605, and the anvil607from a proximal position, as shown inFIG. 6A, to a distal position, as shown inFIG. 6B. The instrument600may be configured such that the anvil607assumes the insertion position when the coring handle611, the cannula interface613, and the coring tube615are in the proximal position, and the anvil607returns to the coring position as the coring handle611, the cannula interface613, and the coring tube615are translated from the proximal position toward the distal position. The coring handle611, the cannula interface613, and the coring tube615also may be configured to rotate with respect to the main handle603, the shaft605, and the anvil607. The main handle603may include a plurality of indicators617that correspond to a distance between a distal end (i.e., a coring edge) of the coring tube615and a proximal end of the anvil607(when the anvil607is in the coring position), as the coring handle611, the cannula interface613, and the coring tube615translate axially with respect to the main handle603, the shaft605, and the anvil607.

The instrument600may be used following attachment of the port406to the heart wall via the anchoring device402, as may be achieved with another instrument, such as the delivery tool described in the '346 Application or one of the first instruments902,1002,1202,1302described below. An initial incision may be created in the heart wall with a scalpel or other cutting device that is advanced through the aperture of the port406. Then, with the coring handle611, the cannula interface613, and the coring tube615in the distal position and the anvil607in the insertion position, the anvil607may be inserted through the initial incision and into the ventricle of the heart. After insertion into the ventricle, the coring handle611, the cannula interface613, and the coring tube615may be translated from the proximal position toward the distal position, thereby causing the anvil607to move from the insertion position to the coring position. With the anvil607in the coring position, the main handle603may be drawn toward the user (i.e., moved proximally away from the heart wall) until the anvil607engages the inner surface of the heart wall. In this manner, the anvil607may act as a “backstop” for controlling the heart wall and providing counter-traction for advancing the coring tube615toward and into the heart wall.

The coring handle611, the cannula interface613, and the coring tube615may be further translated toward the distal position until the distal end of the coring tube615contacts the outer surface of the heart wall. At that point, the coring handle611may be still further translated toward the distal position and also rotated with respect to the main handle603, the shaft605, and the anvil607. In this manner, the instrument600may simultaneously core a hole in the heart wall as the coring tube615advances therethrough and attach the valved cannula470to the port406as the threads472of the cannula470and the threads474of the port406engage one another. When the cannula470is attached to the port406, the cannula470may be inserted at least partially through the hole formed in the heart wall. After the hole is formed in the heart wall and the cannula470is securely attached to the port406, the cannula interface613may be detached from the cannula470and the entire instrument600may be removed from the heart wall and the connector400. The coring tube615and the anvil607may be configured to retain the tissue core removed from the heart wall within the coring tube615. As the coring tube615is removed from the cannula470, the hemostasis valve462may close to prevent blood loss through the connector400. A VAD then may be implanted in the heart wall via the connector400. In particular, an inlet tube of the VAD may be inserted at least partially through the cannula470and at least partially through the hole in the heart wall such that the inlet tube is in communication with the ventricle of the heart. When the inlet tube is inserted through the cannula470, the hemostasis valve462may assume an open position and may form a seal against the outer surface of the inlet tube.

FIG. 7illustrates an embodiment of an instrument700for coring a hole in a heart wall (which also may be referred to as a “tissue wall”) and attaching a cannula to a port of an apical connector (which also may be referred to as a “heart connector” or a “tissue connector”). The instrument700may be configured for use with the apical connector400described above, including the valved cannula470and the port406, or any of the other connectors described herein or in the applications listed above.

The instrument700may include various features corresponding to those described above with respect to the instrument600, which features are identified inFIG. 7with corresponding reference numbers. As shown, the instrument700, may include a main handle703, a shaft705, an anvil707, a coring handle711, a cannula interface713, a coring tube715, and a plurality of indicators717, which features generally are configured in a similar manner. In contrast to the axial configuration of the main handle603of the instrument600, the main handle703of the instrument700may have an offset or “pistol-grip” configuration, as shown inFIG. 7. For certain users, the pistol-grip configuration of the main handle703may provide improved visibility of the heart wall and the connector and/or improved control of the instrument700.

FIG. 8illustrates an embodiment of an instrument800for coring a hole in a heart wall (which also may be referred to as a “tissue wall”) and attaching a cannula to a port of an apical connector (which also may be referred to as a “heart connector” or a “tissue connector”). The instrument800may be configured for use with the apical connector400described above, including the valved cannula470and the port406, or any of the other connectors described herein or in the applications listed above.

The instrument800may include a handle803and a cannula interface813rigidly attached to the distal end of the handle803. As shown, the instrument800also may include a coring tube815rigidly attached to the handle803and extending distally beyond the cannula interface813. The instrument800further may include a coring anchor819rigidly attached to the handle803and extending distally beyond the coring tube815. The cannula interface813may be configured for removably attaching to and retaining a cannula of an apical connector, such as the valved cannula470of the apical connector400, as shown. The coring tube815may be configured for contacting the heart wall and coring a hole therein, as described in detail below. When the cannula470is attached to the cannula interface813, the hemostasis valve462may assume an open position and may form a seal against the outer surface of the coring tube815. The coring anchor819may be configured for attaching to the heart wall prior to the coring tube815contacting the heart wall. As shown, the coring anchor819may include one or more helical coils821configured for advancing into the heart wall. The one or more coils821may have a straight helical shape (i.e., a cylindrical shape) such that a helical diameter of the coil821is constant or substantially constant from the proximal end to the distal end of the coil103. In other embodiments, the coring anchor819may include one or more pins, prongs, barbs, hooks, staples, or other similar features configured for advancing into the heart wall.

The instrument800may be used following attachment of the port406to the heart wall via the anchoring device402, as may be achieved with another instrument, such as the delivery tool described in the '346 Application or one of the first instruments902,1002,1202,1302described below. The distal end of the instrument800may be inserted through the aperture of the port406until the coring anchor819contacts the outer surface of the heart wall. The coring anchor819then may be advanced into the heart wall, by axial translation and/or rotation of the handle803, depending on the type of coring anchor819used. For the coiled coring anchor819shown, the handle803may be rotated and axially translated according to the helical path or paths defined by the one or more coils821.

As the coring anchor819is advanced into the heart wall, the distal end of the coring tube815approaches and eventually contacts the outer surface of the heart wall. At this point, the coring anchor819may provide counter-traction for advancing the coring tube815into the heart wall. As the handle803is further rotated and axially translated according to the path of the coiled coring anchor819, the instrument800may simultaneously core a hole in the heart wall as the coring tube815advances therethrough and attach the valved cannula470to the port406as the threads472of the cannula470and the threads474of the port406engage one another. When the cannula470is attached to the port406, the cannula470may be inserted at least partially through the hole formed in the heart wall. After the hole is formed in the heart wall and the cannula470is securely attached to the port406, the cannula interface813may be detached from the cannula470and the entire instrument800may be removed from the heart wall and the connector400. The coring tube815and the coring anchor819may be configured to retain the tissue core removed from the heart wall within the coring tube815. As the coring tube815is removed from the cannula470, the hemostasis valve462may close to prevent blood loss through the connector400. A VAD then may be implanted in the heart wall via the connector400. In particular, an inlet tube of the VAD may be inserted at least partially through the cannula470and at least partially through the hole in the heart wall such that the inlet tube is in communication with the ventricle of the heart. When the inlet tube is inserted through the cannula470, the hemostasis valve462may assume an open position and may form a seal against the outer surface of the inlet tube.

FIGS. 9A and 9Billustrate an embodiment of an instrument system900for securing a port of an apical connector (which also may be referred to as a “heart connector” or a “tissue connector”) to a heart wall (which also may be referred to as a “tissue wall”), coring a hole in the heart wall, and attaching a cannula to the port of the apical connector. The instrument system900may be configured for use with the apical connector400described above, including the valved cannula470and the port406, or any of the other connectors described herein or in the applications listed above.

The instrument system900may include a first instrument902for securing the port406of the connector400to the heart wall via the anchoring device402, and a second instrument932for coring a hole in the heart wall and attaching the valved cannula470to the port406. The instrument system900also may include a centering guide952for guiding each of the first instrument902and the second instrument932toward the heart wall to provide systemic concentricity.

The first instrument902may include a handle903and a port interface913rigidly attached to the distal end of the handle903. The port interface913may be configured for removably attaching to and retaining a port of an apical connector, such as the port406of the apical connector400, as shown. The handle903may be cannulated and configured for advancing the port406over the centering guide952in order to secure the port406to the heart wall via the anchoring device402.

The second instrument932may include a handle933and a cannula interface943rigidly attached to the distal end of the handle933. As shown, the second instrument932also may include a coring tube945rigidly attached to the handle933and extending distally beyond the cannula interface943. The cannula interface943may be configured for removably attaching to and retaining a cannula of an apical connector, such as the valved cannula470of the apical connector400, as shown. The coring tube945may be configured for contacting the heart wall and coring a hole therein, as described in detail below. When the cannula470is attached to the cannula interface943, the hemostasis valve462may assume an open position and may form a seal against the outer surface of the coring tube945. The handle933may be cannulated and configured for advancing the coring tube945and the cannula470over the centering guide952in order to core a hole in the heart wall and attach the cannula470to the port406.

The centering guide952may include a handle953and a guide anchor959rigidly attached to the distal end of the handle953. The guide anchor959may be configured for attaching the centering guide952to the heart wall. As shown, the guide anchor959may include one or more helical coils961configured for advancing into the heart wall. In other embodiments, the guide anchor959may include one or more pins, prongs, barbs, hooks, staples, or other similar features configured for advancing into the heart wall. The handle953may be configured for advancing the guide anchor959into the heart wall.

During use of the instrument system900, the centering guide952may be oriented such that the distal end of the guide anchor959contacts the outer surface of the heart wall at an approximate center of the desired implantation site. The guide anchor959then may be advanced into the heart wall, by axial translation and/or rotation of the handle953of the centering guide952, depending on the type of guide anchor959used. For the coiled guide anchor959shown, the handle953may be rotated and axially translated according to the helical path or paths defined by the one or more coils961.

After attachment of the guide anchor959, the first instrument902may be placed over the handle953of the centering guide952, and the port406and the anchoring device402may be axially translated toward the heart wall via the handle903. Once the anchoring device402contacts the outer surface of the heart wall, the anchoring device402may be advanced into the heart wall, by axial translation and/or rotation of the handle903, depending on the type of anchoring device402used. For the coiled anchoring device402shown, the handle903may be rotated and axially translated according to the helical path or paths defined by the one or more coils403. The anchoring device402may be advanced into the heart wall until the distal end of the port406is adequately secured near or against the outer surface of the heart wall, such as by forming a substantially fluid tight or hemostatic seal thereabout. The port interface913then may be detached from the port406, and the entire first instrument902may be removed from the centering guide952.

Next, the second instrument932may be placed over the handle953of the centering guide952, and the coring tube945and the valved cannula470may be axially translated toward the heart wall via the handle933. Once the coring tube945contacts the outer surface of the heart wall, the coring tube945may be advanced into the heart wall, by axial translation and rotation of the handle933. At this point, the guide anchor959of the centering guide952may provide counter-traction for advancing the coring tube945into the heart wall. As the handle933is further translated and rotated according to the path of the threads472of the cannula470and the threads474of the port406, the second instrument932may simultaneously core a hole in the heart wall as the coring tube945advances therethrough and attach the cannula470to the port406as the mating threads472,474engage one another. When the cannula470is attached to the port406, the cannula470may be inserted at least partially through the hole formed in the heart wall. After the hole is formed in the heart wall and the cannula470is securely attached to the port406, the cannula interface943may be detached from the cannula470and the entire second instrument932may be removed from the centering guide952. Alternatively, the second instrument932and the centering guide952may be simultaneously removed from the heart wall. The guide anchor959may be configured to retain the tissue core removed from the heart wall. As the coring tube945is removed from the cannula470, the hemostasis valve462may close to prevent blood loss through the connector400. A VAD then may be implanted in the heart wall via the connector400. In particular, an inlet tube of the VAD may be inserted at least partially through the cannula470and at least partially through the hole in the heart wall such that the inlet tube is in communication with the ventricle of the heart. When the inlet tube is inserted through the cannula470, the hemostasis valve462may assume an open position and may form a seal against the outer surface of the inlet tube. An advantage of this embodiment of the instrument system900is that the clinician can use the centering guide952with the guide anchor959to preliminarily determine a position and trajectory of the port406, and thus the overall connector400, before establishing the final implantation of the connector400. In particular, the clinician can position, re-orient, and rotate the centering guide952before attaching the port406to the heart wall via the anchoring device402.

FIG. 10illustrates an embodiment of an instrument system1000for securing a port of an apical connector (which also may be referred to as a “heart connector” or a “tissue connector”) to a heart wall (which also may be referred to as a “tissue wall”), coring a hole in the heart wall, and attaching a cannula to the port of the apical connector. The instrument system1000may be configured for use with the apical connector400described above, including the valved cannula470and the port406, or any of the other connectors described herein or in the applications listed above.

The instrument system1000may include a first instrument1002for securing the port406of the connector400to the heart wall via the anchoring device402, and a second instrument1032for coring a hole in the heart wall and attaching the valved cannula470to the port406.

The first instrument1002may include a handle1003and a port interface1013rigidly attached to the handle1003, such as by one or more connecting members1015extending therebetween. The port interface1013may be configured for removably attaching to and retaining a port of an apical connector, such as the port406of the apical connector400, as shown. The handle1003may be cannulated and configured for allowing the second instrument1032to extend therethrough.

The second instrument1032may include a handle1033and a cannula interface1043rigidly attached to the distal end of the handle1033. As shown, the second instrument1032also may include a coring tube1045rigidly attached to the handle1033and extending distally beyond the cannula interface1043. The second instrument1032further may include a coring anchor1047rigidly attached to the handle1033and extending distally beyond the coring tube1045. The cannula interface1043may be configured for removably attaching to and retaining a cannula of an apical connector, such as the valved cannula470of the apical connector400, as shown. The coring tube1045may be configured for contacting the heart wall and coring a hole therein, as described in detail below. When the cannula470is attached to the cannula interface1043, the hemostasis valve462may assume an open position and may form a seal against the outer surface of the coring tube1045. The coring anchor1047may be configured for attaching to the heart wall prior to the coring tube1045contacting the heart wall. As shown, the coring anchor1047may include one or more helical coils1049configured for advancing into the heart wall. In other embodiments, the coring anchor1047may include one or more pins, prongs, barbs, hooks, staples, or other similar features configured for advancing into the heart wall.

During use of the instrument system1000, the first instrument1002may be oriented such that the distal end of the anchoring device402contacts the outer surface of the heart wall while the central axis ACof the connector400is at an approximate center of the desired implantation site. Once the anchoring device402contacts the outer surface of the heart wall, the anchoring device402may be advanced into the heart wall, by axial translation and/or rotation of the handle1003, depending on the type of anchoring device402used. For the coiled anchoring device402shown, the handle1003may be rotated and axially translated according to the helical paths or paths defined by the one or more coils403. The anchoring device402may be advanced into the heart wall until the distal end of the port406is adequately secured near or against the outer surface of the heart wall, such as by forming a substantially fluid tight or hemostatic seal thereabout.

Next, the second instrument1032may be placed through the handle1003of the first instrument1002, and the coring anchor1047, the coring tube1045, and the valved cannula470may be axially translated toward the heart wall via the handle1033until the coring anchor1047contacts the outer surface of the heart wall. The coring anchor1047then may be advanced into the heart wall, by axial translation and/or rotation of the handle1033, depending on the type of coring anchor1047used. For the coiled coring anchor1047shown, the handle1033may be rotated and axially translated according to the helical path or paths defined by the one or more coils1049.

As the coring anchor1047is advanced into the heart wall, the distal end of the coring tube1045approaches and eventually contacts the outer surface of the heart wall. At this point, the coring anchor1047may provide counter-traction for advancing the coring tube1045into the heart wall. As the handle1033is further rotated and axially translated according to the path of the coiled coring anchor1047, the second instrument1032may simultaneously core a hole in the heart wall as the coring tube1045advances therethrough and attach the valved cannula470to the port406as the threads472of the cannula470and the threads474of the port406engage one another. When the cannula470is attached to the port406, the cannula470may be inserted at least partially through the hole formed in the heart wall. After the hole is formed in the heart wall and the cannula470is securely attached to the port406, the cannula interface1043may be detached from the cannula470and the entire second instrument1032may be removed from the heart wall and the connector400, and the port interface1013may be detached from the port406and the entire first instrument1002may be removed from the heart wall and the connector400. The second instrument1032and the first instrument1002may be sequentially or simultaneously removed. The coring tube1045and the coring anchor1047may be configured to retain the tissue core removed from the heart wall within the coring tube1045. As the coring tube1045is removed from the cannula470, the hemostasis valve462may close to prevent blood loss through the connector400. A VAD then may be implanted in the heart wall via the connector400. In particular, an inlet tube of the VAD may be inserted at least partially through the cannula470and at least partially through the hole in the heart wall such that the inlet tube is in communication with the ventricle of the heart. When the inlet tube is inserted through the cannula470, the hemostasis valve462may assume an open position and may form a seal against the outer surface of the inlet tube.

Apical Connectors

FIG. 11Aillustrates an embodiment of a portion of an apical connector1100(which also may be referred to as a “heart connector” or a “tissue connector”) configured for securing in a heart wall (which also may be referred to as a “tissue wall”) to facilitate in vivo implantation of a VAD and its attachment to the heart. The connector1100may include an anchoring device1102, a port1106, and a cannula1170having a hemostasis valve1162, as shown, which features may correspond generally to those described with respect to the various embodiments of the '346 Application, although certain differences are described herein below. It will be appreciated that the connector1100also may include other features, such as a coupler device, configured in a manner similar to those described with respect to the various embodiments of the '346 Application. Additional views of portions of the apical connector1100are provided inFIGS. 11B and 11C.

The anchoring device1102may be configured for advancing at least partially through the heart wall to secure the connector1100thereto for subsequent implantation of a VAD. The port1106may be fixedly (i.e., rigidly) attached to a proximal portion of the anchoring device1102and may define a central aperture1114therethrough. In this manner, upon advancing a distal portion of the anchoring device1102at least partially through the heart wall, the port1106may be positioned against or near the heart wall and the aperture1114may provide access to the heart wall. The cannula1170may be configured for positioning through the aperture1114of the port1106and at least partially through the heart wall. The hemostasis valve1162may be disposed within the cannula1170and configured for controlling fluid communication therethrough. During use, the apical connector1100may be secured to the heart wall to facilitate in vivo implantation of the VAD and its attachment to the heart in a manner similar to that described with respect to the various embodiments of the '346 Application.

The anchoring device1102may include a plurality of helical coils1103positioned about a central axis ACof the connector1100and configured for advancing at least partially into the heart wall along respective helical paths defined by the coils1103. For example, as shown inFIGS. 11A and 11B, the anchoring device1102may include two coils1103that are offset from one another and arranged in a generally symmetric manner about the central axis ACof the connector1100. In particular, the two coils1103may be attached to the port1106at attachment points1121that are spaced apart from one another, for example, by 180-degrees in a circumferential direction with respect to the central axis ACof the connector1100. Distal tips1122(i.e., distal ends) of the two coils1103also may be spaced apart from one another, for example, by 180-degrees in a circumferential direction with respect to the central axis ACof the connector1100. In this manner, the coils1103may follow separate, opposing helical paths in the myocardial wall. In other embodiments, the anchoring device1102may include three or more coils1103that are offset from one another and arranged in a generally symmetric manner about the central axis ACof the connector1100, such that the coils103follow separate helical paths in the myocardial wall. The three or more coils103may include attachment points1121and distal tips1122that are equally spaced from one another in a circumferential direction with respect to the central axis ACof the connector1100. In various embodiments, the anchoring device1102may include two or more coils1103that are “clocked” (i.e., circumferentially spaced) from each other by 20 degrees, 25 degrees, 30 degrees, 45 degrees, 60 degrees, 90 degrees, or 120 degrees with respect to the central axis ACof the connector1100. As shown, the coils1103may have a radially-expanding helical shape (i.e., a conical shape) such that a helical diameter of the coil1103increases from the proximal end to the distal end of the coil1103. Due to the radially-expanding helical shape, the coils1103may be configured to compress at least a portion of the heart wall inward toward the central axis ACof the connector1100when the anchoring device1102is advanced through the heart wall. It will be appreciated from the description herein that the anchoring device1102may include other anchoring mechanisms (other than coils) common in the surgical field, such as clips, staples, and screws. In some embodiments, the anchoring device102may include a combination of different anchoring mechanisms.

As compared to embodiments in which the anchoring device1102includes only a single coil1103, the plurality of coils1103of the foregoing embodiments may improve stability of the port1106as well as the overall connector1100when secured in the heart wall. In particular, the plurality of coils1103may provide balanced engagement of the heart wall and prevent the port1106from lifting off of the heart wall (opposite the coil insertion point), as may be experienced with a single coil configuration of the anchoring device1102. As will be appreciated, the plurality of coils1103may enhance initial starting and advancing of the anchoring device1102in the heart wall in a manner similar to that of a multi-start threadform. Additionally, as compared to a single coil configuration, the coils1103may be shorter, resulting in increased rigidity of the coils1103, which may improve implantation consistency as well as full engagement feedback as the anchoring device1102is secured in the heart wall. Further, the balanced engagement provided by the plurality of coils1103may improve hemostasis achieved upon implantation of the connector1100, for example by ensuring balanced contact between the port1106and the heart wall, or between an additional sealing element of the connector1100and the heart wall.

As shown inFIGS. 11A and 11B, each coil1103may include a proximal portion1123fixedly (i.e., rigidly) attached to the port1106and a distal portion1125extending distally away from the port1106and configured for advancing at least partially into the heart wall. The proximal portion1123may be disposed on a proximal side of a circumferential flange1132of the port1106, and the distal portion1125may be disposed on a distal side of the flange1132. In some embodiments, each coil1103may be attached to the port1106via one or more welds at the respective attachment point1121. In particular, the proximal portion1123of the coil1103may be attached to the proximal surface of the flange1132via one or more welds therebetween at the respective attachment point1121. According to this configuration, the one or more welds at the attachment point1121may be compressed upon extension of the distal portion1125of the coil1103, as may be experienced during or after advancement of the distal portion1125into the heart wall. Such compression may limit loading on the one or more welds and enhance durability of the attachment point1121under fatigue, as may be experienced during use of the apical connector1100in the heart wall.

The port1106may be formed as a substantially ring-shaped member defining the central aperture1114therethrough and configured for positioning against or near the heart wall. As noted above, the port1106may be fixedly (i.e., rigidly) attached to the anchoring device1102, in particular the proximal portions1123of the coils1103. In this manner, axial rotation of the port1106results in corresponding axial rotation of the anchoring device1102for advancing the anchoring device1102at least partially into the tissue wall. The port1106may include one or more engagement features configured for engaging an instrument used to secure the port1106to the heart wall via the anchoring device1102. For example, the port1106may include one or more engagement apertures1135(which also may be referred to as “engagement recesses”) defined in the proximal end of the port1106and configured for receiving a mating feature of the instrument. Alternatively or additionally, the port1160may include one or more engagement notches1137(which also may be referred to as “engagement recesses”) defined in the proximal end of the port1106along the circumferential outer surface thereof and configured for receiving a mating feature of the instrument. Certain embodiments of an instrument that may be used to secure the port1106to the heart wall are described herein below.

The port1106also may include one or more engagement features configured for engaging an instrument used to stabilize the port1106after the port1106has been secured to the heart wall. For example, the port1106may include a plurality of engagement notches1139(which also may be referred to as “engagement recesses”) defined in the circumferential outer surface of the port1106and configured for receiving a mating feature of the instrument. The notches1139may be configured for allowing the instrument to engage the port1106from a plurality of directions relative to the aperture1114of the port1106and the central axis ACof the connector1100. As shown, the notches1139may be arranged in a circumferential array along the circumferential outer surface of the port1106and may have a plurality of engagement tabs1141(which also may be referred to as “engagement protrusions”) positioned therebetween. In other words, one of the engagement tabs1141may be positioned between each adjacent pair of the engagement notches1139. In some embodiments, as shown, the notches1139may provide discrete engagement positions every 10 degrees about the circumferential outer surface of the port1106. According to other embodiments, the notches1139may provide discrete engagement positions every 5 degrees, 15 degrees, 30 degrees, 45 degrees, or 90 degrees about the circumferential outer surface of the port1106. Certain embodiments of an instrument that may be used to stabilize the port1106after the port1106has been secured to the heart wall are described herein below.

The cannula1170may be formed as a substantially tube-shaped member configured for positioning through the aperture1114of the port1106and at least partially through the heart wall. The cannula1170may include one or more features configured for releasably attaching the cannula1170to the port1106. For example, as shown, the cannula1170may include one or more locking members1171(which also may be referred to as “locking arms” or “locking tabs”) positioned near but offset from the proximal end of the cannula1170and extending along the outer circumferential surface of the cannula1170. Each locking member1171may extend from a partial flange1173of the cannula1170and may be resilient or spring-like and configured to deflect from a natural position (as shown via dashed lines inFIG. 11A) to a biased position (as shown via solid lines inFIG. 11A) when a biasing force is applied thereto via mating features of the port1106as the cannula1170is attached to the port1106. In some embodiments, in the natural position, the locking member1171may extend at least partially toward the proximal end of the cannula1170in an angled relationship with respect to the partial flange1173, and in the biased position, the locking member1171may be deflected at least partially away from the proximal end of the cannula1170to or toward a coplanar relationship with the partial flange1173.

The port1106may include one or more recesses1175defined in the proximal end of the port1106and configured to allow the locking members1171and the partial flanges1173to be inserted axially therein. The port1106also may include one or more undercut grooves1177defined near the proximal end of the port1106and extending along the inner circumferential surface of the port1106. Each undercut groove1177may be positioned adjacent to and in communication with one of the recesses1175. The undercut grooves1177may be configured to receive the partial flanges1173and the locking members1171of the cannula1170upon rotation of the cannula1170with respect to the port1106. The cannula1170may include one or more engagement features configured for engaging an instrument used to position the cannula1170within the aperture1114of the port1106and rotate the cannula1170with respect to the port1106. For example, the cannula1170may include a plurality of engagement notches1178(which also may be referred to as “engagement recesses”) defined in the proximal end of the cannula1170and configured for receiving a mating feature of the instrument. In some embodiments, as shown, the engagement notches1178may extend to the inner circumferential surface of the cannula1170. In other embodiments, the engagement notches1178may extend to the outer circumferential surface of the cannula1170. Certain embodiments of an instrument that may be used to position the cannula1170within the aperture1114of the port1106and rotate the cannula1170with respect to the port1106are described herein below.

The port1106further may include one or more locking protrusions1181(which also may be referred to as “locking tabs”) and one or more stop protrusions1183(which also may be referred to as “stop tabs”). The locking protrusions1181may be configured to deflect the locking members1171of the cannula1170distally (i.e., away from the proximal end of the cannula1170) from their natural position upon rotation of the cannula1170with respect to the port1106in a first direction, such as a clockwise direction when viewed from the proximal end of the connector1100. The stop protrusions1183may be configured to contact the locking members1171and/or the partial flanges1173and limit rotation of the cannula1170with respect to the port1106in the first direction. The locking members1171may be configured to return to or toward their natural position after advancing past the locking protrusions1181, such that the locking members1171and the locking protrusions1181cooperate to prevent rotation of the cannula1170with respect to the port1106in an opposite second direction, such as a counter clockwise direction when viewed from the proximal end of the connector1100. In this manner, the mating features of the cannula1170and the port1106may form a partial-turn locking mechanism configured to prevent the cannula1170from being detached from the port1106unless the locking members1171are biased by a user to disengage the locking protrusions1181. According to the embodiment shown inFIGS. 11A-11C, the partial-turn locking mechanism is a ¼-turn locking mechanism, although other configurations are possible, such as a ⅓-turn or a ½-turn configuration.

As compared to some other connector embodiments, the partial-turn locking mechanism of the connector1100provides a means for locking the cannula1170to the port1106, which may improve the structural integrity of the connector1100as well as the hemostasis achieved upon implantation of the connector1100. Moreover, the partial-turn locking mechanism provides tactile feedback as the cannula1170is attached to the port1106.

The partial-turn locking mechanism of the connector1100may be released to allow the cannula1170to be detached from the port1106. In particular, the partial-turn locking mechanism may be released by inserting portions of an instrument through the engagement apertures1135of the port1106and biasing the locking members1171of the cannula1170distally such that the locking members1171disengage the locking protrusions1181. Such disengagement of the locking members1171and the locking protrusions1181may allow the cannula1170to be rotated in the second direction and then axially removed from the port1106. Certain embodiments of an instrument that may be used to release the partial-turn locking mechanism are described in PCT Application No. PCT/US2015/019308 (the '308 application) and referred to therein as a cannula release tool. As described, the cannula release tool may include a pair of prongs. It will be appreciated that the prongs may be inserted through the engagement apertures1135of the port1106to bias the locking members1171of the cannula1170distally such that the locking members1171disengage the locking protrusions1181, thereby allowing the cannula1170to be rotated in the second direction and then axially removed from the port1106.

The cannula1170may include one or more features configured for facilitating attachment of a VAD to the apical connector1100. For example, as shown, the cannula1170may include a proximal flange1185(which also may be referred to as a “proximal lip”) positioned at or near the proximal end of the cannula1170and extending along the outer circumferential surface of the cannula1170. The cannula1170also may include an elastomer covering1187molded over a portion of the cannula1170. The elastomer covering1187may extend from the proximal end of the cannula1170to an intermediate flange1189(which also may be referred to as an “intermediate lip”). As shown, the partial flanges1173may be attached to and coplanar with the intermediate flange1189. In other embodiments, the intermediate flange1189may be offset from the partial flanges1173. As shown, the elastomer covering1187may extend partially over the engagement notches1178along the proximal end of the cannula1170, which may facilitate retention of mating features of an instrument within the engagement notches1178during positioning of the cannula1170with respect to the port1106. In some embodiments, the elastomer covering1187may extend partially into the engagement notches1178, which also may facilitate retention of mating features of the instrument. The elastomer covering1187may include a plurality of ridges1191defined in the circumferential outer surface of the elastomer covering1187, positioned distally with respect to the proximal flange1185and extending toward the distal end of the cannula1170.

When the cannula1170is attached to the port1106, a circumferential groove or gap may exist between the proximal flange1185and the proximal end of the port1106. The circumferential groove may be configured to receive a mating portion of a locking mechanism, such as a clip, for attaching a VAD to the connector1100. In some embodiments, the mating portion of the locking mechanism, such as the clip, may include features configured to engage the ridges1191and thereby limit rotation of the locking mechanism and the VAD relative to the cannula1170and the overall connector1100. Certain embodiments of locking mechanisms that may be used to attach a VAD or heart pump to a ventricular cuff are described in the '308 application. It will be appreciated that a proximal portion of the cannula1170, including the proximal flange1185, the elastomer covering1187, the intermediate flange1189, and the ridges1191thereof, may be configured in a manner similar to corresponding features of the various embodiments of cuffs described in the '308 application. In this manner, the cannula1170and the overall connector1100may be configured for attachment of a VAD via one or more of the embodiments of locking mechanisms described in the '308 application.

As shown inFIGS. 11A and 11B, the apical connector1100may include a sewing ring1193extending outwardly from the port1106. The sewing ring1193may extend about the outer perimeter of the port1106and may be configured for suturing to the heart wall. The sewing ring1193may be made of a porous material, such as PTFE felt. Certain embodiments of sewing rings used as a part of ventricular cuffs are described in the '308 application. The sewing ring1193of the connector1100may have features and characteristics similar to those of the various embodiments of sewing rings described in the '308 application and may be attached to the port1106using attachment features and/or methods similar to those described therein.

Instruments

FIGS. 12A and 12Billustrate an embodiment of an instrument system1200for securing a port of an apical connector (which also may be referred to as a “heart connector” or a “tissue connector”) to a heart wall (which also may be referred to as a “tissue wall”), coring a hole in the heart wall, and attaching a cannula to the port of the apical connector. The instrument system1200may be configured for use with the apical connector1100described above, including the valved cannula1170and the port1106, or any of the other connectors described herein or in the applications listed above.FIGS. 12C-12Hillustrate an example method of using the instrument system1200to secure the port1106of the apical connector1100in a heart wall, core a hole in the heart wall, and attach the valved cannula1170to the port1106.

The instrument system1200may include a first instrument1202for securing the port1106of the connector1100to the heart wall via the anchoring device1102, and a second instrument1232for coring a hole in the heart wall and attaching the valved cannula1170to the port1106.

The first instrument1202may include a handle1203and a port interface1213rigidly attached to the distal end of the handle1203. The port interface1213may be configured for removably attaching to and retaining a port of an apical connector, such as the port1106of the apical connector1100, as shown. For example, the port interface1213may include one or more engagement protrusions1215(which also may be referred to as “engagement tabs”) configured for inserting into the engagement apertures1135and/or the engagement notches1137of the port1106. In some embodiments, the first instrument1202may include a guide member1217rigidly attached to the handle1203and extending distally beyond the port interface1213. In this manner, the guide member1217may contact and be advanced into the heart wall prior to the anchoring device1102, which may facilitate placement of the port1106at a desired implantation site, such as the apex of the heart. In other embodiments, the handle1203may be cannulated and configured for advancing the port1106and the first instrument1202over a separate guide member, such as a guide wire, previously placed in the heart wall.

The second instrument1232may include a main handle1233, a shaft1235rigidly attached to the main handle1233and extending distally therefrom, and a coring anchor1237rigidly attached to the distal end of the shaft1235and extending distally therefrom. The coring anchor1237may be configured for attaching to the heart wall. As shown, the coring anchor1237may include one or more helical coils1239configured for advancing into the heart wall. In other embodiments, the coring anchor1237may include one or more pins, prongs, barbs, hooks, staples, or other similar features configured for advancing into the heart wall. The second instrument1232also may include a coring sleeve1241(which also may be referred to as an “inner sleeve”) and a coring tube1243rigidly attached to the distal end of the coring sleeve1241and extending distally therefrom. The coring tube1243may be configured for contacting the heart wall and coring a hole therein, as described in detail below. The second instrument1232further may include an attachment sleeve1247(which also may be referred to as an “outer sleeve”) and a cannula interface1249rigidly attached to the distal end of the attachment sleeve1247and extending distally therefrom. The cannula interface1249may be configured for removably attaching to and retaining a cannula of an apical connector, such as the valved cannula1170of the apical connector1100. For example, the cannula interface1249may include one or more engagement protrusions1251configured for inserting into the engagement notches1178of the cannula1170.

The coring sleeve1241may be configured for advancing the coring tube1243toward the heart wall and through the aperture1114of the port1106to core a hole in the heart wall, as described in detail below. The coring sleeve1241and the coring tube1243may be cannulated and movably positioned over respective portions of the shaft1235and the coring anchor1237. In particular, the coring sleeve1241and the coring tube1243may be configured to translate axially with respect to the main handle1233, the shaft1235, and the coring anchor1237from a proximal position, as shown inFIG. 12A, to a distal position, as shown inFIG. 12B. Such axial translation of the coring sleeve1241may be limited in the proximal direction by contact between the coring sleeve1241and the main handle1233and in the distal direction by contact between an inner flange1255of the coring sleeve1241and a boss1257of the shaft1235. In some embodiments, as shown inFIG. 12A, the coring anchor1237may be positioned entirely within the coring tube1243when the coring sleeve1241and the coring tube1243are in the proximal position. In other embodiments, as shown inFIG. 12E, a distal portion of the coring anchor1237may extend distally beyond the distal end of the coring tube1243when the coring sleeve1241and the coring tube1243are in the proximal position. In some embodiments, the coring sleeve1241and the coring tube1243may be configured to rotate with respect to the main handle1233and the shaft1235. In other embodiments, the coring sleeve1241and the coring tube1243may be rotatably keyed, either directly or indirectly, to the main handle1233and/or the shaft1235.

The attachment sleeve1247may be configured for advancing the cannula interface1249(and the cannula1170attached thereto) toward the port1106previously attached to the heart wall via the anchoring device1102, as described in detail below. The attachment sleeve1247and the cannula interface1249may be cannulated and movably positioned over respective portions of the coring sleeve1241, the coring tube1243, the shaft1235, and the coring anchor1237. In particular, the attachment sleeve1247and the cannula interface1249may be configured to translate axially with respect to the coring sleeve1241, the coring tube1243, the shaft1235, and the coring anchor1237from a proximal position, as shown inFIG. 12A, to a distal position, as shown inFIG. 12B. Such axial translation of the attachment sleeve1247may be limited in the proximal direction by contact between the attachment sleeve1247and the main handle1233and in the distal direction by contact between a proximal end of one or more axial grooves1261of the attachment sleeve1247and a proximal end of one or more axial ribs1263of the coring sleeve1241. In some embodiments, as shown inFIGS. 12A and 12E, a distal portion of the coring tube1243may extend distally beyond the distal end of the cannula interface1249and beyond the distal end of the cannula1170when the attachment sleeve1241and the cannula interface1249are in the proximal position. In some embodiments, the attachment sleeve1247and the cannula interface1249may be rotatably keyed to the coring sleeve1241and the coring tube1243. For example, the attachment sleeve1247and the coring sleeve1241may be rotatably keyed to one another via the axial grooves1261and the axial ribs1263.

The second instrument1232may be adjusted between a first configuration, as shown inFIG. 12A, for coring a hole in a heart wall and attaching the cannula1170to the port1106, and a second configuration, as shown inFIG. 12B, for retrieving a tissue core removed from the heart wall and detaching the second instrument1232from the cannula1170. The second instrument1232may include one or more buttons or switches1267positioned on the main handle1233and configured for releasably engaging the attachment sleeve1247. In particular, distal portions of the switches1267, which may be formed as teeth, may releasably engage one or more engagement notches1269(which also may be referred to as “engagement recesses”) defined in the attachment sleeve1247at or near the proximal end of the attachment sleeve1247. When the second instrument1232is in the first configuration, engagement between the switches1267and the engagement notches1269may maintain the attachment sleeve1247and the cannula interface1249in their proximal position, which in turn may maintain the coring sleeve1241and the coring tube1243in their proximal position. Upon release of the switches1267(i.e., disengagement of the switches1267and the engagement notches1269), the second instrument1232may be adjusted to the second configuration, in which the attachment sleeve1247and the cannula interface1249are in their distal position and the coring sleeve1241and the coring tube1243are in their distal position.

When the second instrument1232is in the first configuration, the attachment sleeve1247and the cannula interface1249may be rotatably keyed to the main handle1233. For example, as shown, the main handle1233may include one or more engagement protrusions1273(which also may be referred to as “engagement tabs”) extending from the distal end thereof and configured for engaging one or more engagement notches1275(which also may be referred to as “engagement recesses”) defined in the proximal end of the attachment sleeve1247when the attachment sleeve1247is in its proximal position. As described above, the attachment sleeve1247and the coring sleeve1241may be rotatably keyed to one another, and the coring anchor1237may be rigidly attached to the shaft1235, which may be rigidly attached to the main handle1233. Accordingly, when the second instrument1232is in the first configuration, rotation of the main handle1233may result in rotation of the coring anchor1237, the coring tube1243, and the attached cannula1170.

During use of the instrument system1200, the port1106may be attached to the first instrument1202via the port interface1213and advanced toward the heart wall, as shown inFIG. 12C. In some embodiments, a guide wire first may be inserted into the heart wall at an approximate center of the desired implantation site, and the first instrument1202and the port1106may be advanced over the guide wire to the heart wall. In other embodiments in which the first instrument1202includes the guide member1217, the first instrument1202may be advanced toward the heart wall such that the guide member1217is inserted therein at an approximate center of the desired implantation site. The first instrument1202, the port1106, and the anchoring device1102may be axially translated toward the heart wall via the handle1203. Once the anchoring device1102contacts the outer surface of the heart wall, the anchoring device1102may be advanced into the heart wall, by axial translation and/or rotation of the handle1203, depending on the type of anchoring device1102used. For the coiled anchoring device1102shown, the handle1203may be rotated and axially translated according to the helical paths defined by the coils1103. The anchoring device1102may be advanced into the heart wall until the distal end of the port1106and/or the sewing ring1193is adequately secured against the outer surface of the heart wall, such as by forming a substantially fluid tight or hemostatic seal thereabout. In certain embodiments, the anchoring device1102is configured to be secured in the heart wall after a predetermined number of rotations. In certain embodiments, a marker provides visual confirmation to a user that the port1106is secured and flush against the heart wall. The port interface1213then may be detached from the port1106, and the entire first instrument1202may be removed from the patient, leaving the port1106secured to the heart wall, as shown inFIG. 12D. In some embodiments, the sewing ring1193may be sutured to the heart wall to further secure the port1106to the heart wall, to enhance a seal between the sewing ring1193and the heart wall, and/or to further inhibit rotation of the anchoring device1102out of the heart wall.

Next, with the second instrument1232in the first configuration, the valved cannula1170may be attached to the second instrument1232via the cannula interface1249and advanced toward the heart wall, as shown inFIG. 12E. The second instrument1232and the cannula1170may be axially translated toward the heart wall via the main handle1233. The distal end of the second instrument1232may be inserted through the aperture1114of the port1106until the coring anchor1237contacts the outer surface of the heart wall. The coring anchor1237then may be advanced into the heart wall, by axial translation and/or rotation of the main handle1233, depending on the type of coring anchor1237used. For the coiled coring anchor1237shown, the handle1233may be rotated and axially translated according to the helical path defined by the coil1239.

As the coring anchor1237is advanced into the heart wall, the distal end of the coring tube1243approaches and eventually contacts the outer surface of the heart wall. At this point, the coring anchor1237may provide counter-traction for advancing the coring tube1243into the heart wall. As the main handle1233is further rotated and axially translated according to the path of the coiled coring anchor1237, the second instrument1232may simultaneously core a hole in the heart wall as the coring tube1243advances therethrough and position the valved cannula1170through the port1106and at least partially through the heart wall via the hole formed therein. The main handle1233may be rotated and axially translated until the cannula1170securely attaches to the port1106, as shown inFIG. 12F. The cannula1170may be attached to the port1106via the partial-turn locking mechanism, as shown, or other means of attachment.

After the hole is formed in the heart wall and the cannula1170is securely attached to the port1106, the switches1267may be released and the second instrument1232may be adjusted from the first configuration to the second configuration by pulling the main handle1233proximally away from the heart wall. As the second instrument1232is adjusted from the first configuration to the second configuration, the coring anchor1237may move into the coring tube1243while holding the tissue core removed from the heart wall, and the coring tube1243may move into the attachment sleeve1247, as shown inFIG. 12G. The cannula interface1249then may be detached from the cannula1170and the entire second instrument1232may be removed from the heart wall and the connector1100, as shown inFIG. 12H. The coring tube1243and the coring anchor1237may be configured to retain the tissue core removed from the heart wall within the coring tube1243. As the coring tube1243is removed from the cannula1170, the hemostasis valve1162may close to prevent blood loss through the connector1100. A VAD or other instrument then may be implanted in the heart wall via the connector1100. In particular, an inlet tube of a VAD may be inserted at least partially through the cannula1170and at least partially through the hole in the heart wall such that the inlet tube is in communication with the ventricle of the heart. When the inlet tube is inserted through the cannula1170, the hemostasis valve1162may assume an open position and may form a seal against the outer surface of the inlet tube.

FIGS. 13A and 13Billustrate an embodiment of an instrument system1300which is similar in many respects to the instrument system1200except that the second instrument is guided to the target position for accessing the heart. The instrument system1300is similarly configured for securing a port of an apical connector (which also may be referred to as a “heart connector” or a “tissue connector”) to a heart wall (which also may be referred to as a “tissue wall”), coring a hole in the heart wall, and attaching a cannula to the port of the apical connector. The instrument system1300may be configured for use with the apical connector1100described above, including the valved cannula1170and the port1106, or any of the other connectors described herein or in the applications listed above.FIGS. 13C-13Iillustrate an example method of using the instrument system1300to secure the port1106of the apical connector1100in a heart wall, core a hole in the heart wall, and attach the valved cannula1170to the port1106.

The instrument system1300may include a first instrument1302for securing the port1106of the connector1100to the heart wall via the anchoring device1102, and a second instrument1332for coring a hole in the heart wall and attaching the valved cannula1170to the port1106. The first instrument1302and the second instrument1332may be used together, as described below.

The first instrument1302may include a handle1303and a port interface1313rigidly attached to the handle1303, such as by one or more connecting members1311extending therebetween. The port interface1313may be configured for removably attaching to and retaining a port of an apical connector, such as the port1106of the apical connector1100, as shown. For example, the port interface1313may include one or more engagement protrusions1315(which also may be referred to as “engagement tabs”) configured for inserting into the engagement apertures1135and/or the engagement notches1137of the port1106. Each engagement protrusion1315may extend from an attachment finger or arm1317that is resilient or spring-like and configured to deflect radially outward from a natural position to a biased position when a biasing force is applied thereto via mating features of the port1106as the port interface1313is attached to the port1106. As shown, the first instrument1302may be cannulated and configured for allowing the second instrument1332to extend therethrough. This advantageously guides the second instrument1332to a desired or target location such that the risk of malpositioning is reduced.

The second instrument1332may include a main handle1333, a shaft1335rigidly attached to the main handle1333and extending distally therefrom, and a coring anchor1337rigidly attached to the distal end of the shaft1335and extending distally therefrom. The coring anchor1337may be configured for attaching to the heart wall. As shown, the coring anchor1337may include one or more helical coils1339configured for advancing into the heart wall. In other embodiments, the coring anchor1337may include one or more pins, prongs, barbs, hooks, staples, or other similar features configured for advancing into the heart wall. The second instrument1332also may include a sleeve1341, a coring tube1343rigidly attached to the distal end of the sleeve1341and extending distally therefrom, and a cannula interface1349rigidly attached to the distal end of the sleeve1341and extending distally therefrom. The coring tube1343may be configured for contacting the heart wall and coring a hole therein, as described in detail below. The cannula interface1349may be configured for removably attaching to and retaining a cannula of an apical connector, such as the valved cannula1170of the apical connector1100. For example, the cannula interface1349may include one or more engagement protrusions1351(which also may be referred to as “engagement tabs”) configured for inserting into the engagement notches1178of the cannula1170. As shown inFIGS. 13A and 13D, a distal portion of the coring tube1343may extend distally beyond the distal end of the cannula interface1349and beyond the distal end of the cannula1170.

The sleeve1341may be configured for advancing the coring tube1343toward the heart wall and through the aperture1114of the port1106(previously attached to the heart wall via the anchoring device1102) to core a hole in the heart wall at a target location, and for advancing the cannula interface1349(and the cannula1170attached thereto) toward the port1106, as described in detail below. The sleeve1341, the coring tube1343, and the cannula interface1349may be cannulated and movably positioned over respective portions of the shaft1335and the coring anchor1337. In particular, the sleeve1341, the coring tube1343, and the cannula interface1349may be configured to translate axially with respect to the main handle1333, the shaft1335, and the coring anchor1337from a proximal position, as shown inFIG. 13A, to a distal position, as shown inFIG. 13B. Such axial translation of the sleeve1341may be limited in the proximal direction by contact between the sleeve1341and the main handle1333and in the distal direction by contact between an inner flange1355of the sleeve1341and a boss1357of the shaft1335. In some embodiments, as shown inFIG. 13A, the coring anchor1337may be positioned entirely within the coring tube1343when the sleeve1341, the coring tube1343, and the cannula interface1349are in the proximal position. In other embodiments, as shown inFIG. 13D, a distal portion of the coring anchor1337may extend distally beyond the distal end of the coring tube1343when the sleeve1341, the coring tube1343, and the cannula interface1349are in the proximal position. In some embodiments, the sleeve1341, the coring tube1243, and the cannula interface1349may be configured to rotate with respect to the main handle1333and the shaft1335. In other embodiments, the sleeve1341, the coring tube1243, and the cannula interface1349may be rotatably keyed, either directly or indirectly, to the main handle1333and/or the shaft1335.

The second instrument1332may be adjusted between a first configuration, as shown inFIG. 13A, for coring a hole in a heart wall and attaching the cannula1170to the port1106, and a second configuration, as shown inFIG. 13B, for retrieving a tissue core removed from the heart wall and detaching the second instrument1332from the cannula1170. The second instrument1332may include one or more buttons or switches1367positioned on the main handle1333and configured for releasably engaging the sleeve1341. In particular, distal portions of the switches1367, which may be formed as teeth, may releasably engage one or more engagement notches1369(which also may be referred to as “engagement recesses”) defined in the sleeve1341at or near the proximal end of the sleeve1341. When the second instrument1332is in the first configuration, engagement between the switches1367and the engagement notches1369may maintain the sleeve1341, the coring tube1343, and the cannula interface1349in their proximal position. Upon release of the switches1367(i.e., disengagement of the switches1367and the engagement notches1369), the second instrument1332may be adjusted to the second configuration, in which the sleeve1341, the coring tube1343, and the cannula interface1349are in their distal position.

When the second instrument1332is in the first configuration, the sleeve1341, the coring tube1343, and the cannula interface1349may be rotatably keyed to the main handle1333. For example, as shown, the main handle1333may include one or more engagement protrusions1373(which also may be referred to as “engagement tabs”) extending from the distal end thereof and configured for engaging one or more engagement notches1375(which also may be referred to as “engagement recesses”) defined in the proximal end of the sleeve1341when the sleeve1341is in its proximal position. As described above, the coring anchor1337may be rigidly attached to the shaft1335, which may be rigidly attached to the main handle1333. Accordingly, when the second instrument1332is in the first configuration, rotation of the main handle1333may result in rotation of the coring anchor1337, the coring tube1343, and the attached cannula1170.

During use of the instrument system1300, the port1106may be attached to the first instrument1302via the port interface1313and advanced toward the heart wall, as shown inFIG. 13C. The first instrument1302, the port1106, and the anchoring device1102may be axially translated toward the heart wall via the handle1303. The first instrument1302may be oriented such that the distal end of the anchoring device1102contacts the outer surface of the heart wall while the central axis of the port1106is aligned with an approximate center of the desired implantation site. Once the anchoring device1102contacts the outer surface of the heart wall, the anchoring device1102may be advanced into the heart wall, by axial translation and/or rotation of the handle1303, depending on the type of anchoring device1102used. For the coiled anchoring device1102shown, the handle1303may be rotated and axially translated according to the helical paths defined by the coils1103. The anchoring device1102may be advanced into the heart wall until the distal end of the port1106and/or the sewing ring1193is adequately secured against the outer surface of the heart wall, such as by forming a substantially fluid tight or hemostatic seal thereabout. In certain embodiments, the anchoring device1102is configured to be secured in the heart wall after a predetermined number of rotations. In certain embodiments, a marker provides visual confirmation to a user that the port1106is secured and flush against the heart wall. In some embodiments, the sewing ring1193may be sutured to the heart wall to further secure the port1106to the heart wall, to enhance a seal between the sewing ring1193and the heart wall, and/or to further inhibit rotation of the anchoring device1102out of the heart wall. The first instrument1302may remain attached to the port1106via the port interface1313, as shown inFIG. 13D, and may be used as a guide for the second instrument1332.

Next, with the second instrument1332in the first configuration, the valved cannula1170may be attached to the second instrument1332via the cannula interface1349and advanced toward the heart wall, as shown inFIG. 13D. The second instrument1332and the cannula1170may be placed through the handle1303of the first instrument1302in guided fashion, and the coring anchor1337, the coring tube1343, and the cannula1170may be axially translated toward the heart wall via the main handle1333. The distal end of the second instrument1332may be inserted through the aperture1114of the port1106until the coring anchor1337contacts the outer surface of the heart wall, as shown inFIG. 13E. The coring anchor1337then may be advanced into the heart wall, by axial translation and/or rotation of the main handle1333, depending on the type of coring anchor1337used. For the coiled coring anchor1337shown, the handle1333may be rotated and axially translated according to the helical path defined by the coil1339.

As the coring anchor1337is advanced into the heart wall, the distal end of the coring tube1343approaches and eventually contacts the outer surface of the heart wall. At this point, the coring anchor1337may provide counter-traction for advancing the coring tube1343into the heart wall. As the main handle1333is further rotated and axially translated according to the path of the coiled coring anchor1337, the second instrument1332may simultaneously core a hole in the heart wall as the coring tube1343advances therethrough and position the valved cannula1170through the aperture1114of the port1106and at least partially through the heart wall via the hole formed therein. The main handle1333may be rotated and axially translated until the cannula1170securely attaches to the port1106, as shown inFIG. 13F. The cannula1170may be attached to the port1106via the partial-turn locking mechanism or other means of attachment.

After the hole is formed in the heart wall and the cannula1170is securely attached to the port1106, the switches1367may be released and the second instrument1332may be adjusted from the first configuration to the second configuration by pulling the main handle1333proximally away from the heart wall. As the second instrument1332is adjusted from the first configuration to the second configuration, the coring anchor1337may move into the coring tube1343while holding the tissue core removed from the heart wall, as shown inFIG. 13G. The cannula interface1349then may be detached from the cannula1170and the second instrument1332may be removed from the connector1100, as shown inFIG. 13H. The coring tube1343and the coring anchor1337may be configured to retain the tissue core removed from the heart wall within the coring tube1343. As the coring tube1343is removed from the cannula1170, the hemostasis valve1162may close to prevent blood loss through the connector1100. Next, the port interface1313may be detached from the port1106and the first instrument1302may be removed from the connector1100, as shown inFIG. 13I. A VAD or other instrument then may be implanted in the heart wall via the connector1100. In particular, an inlet tube of a VAD may be inserted at least partially through the cannula1170and at least partially through the hole in the heart wall such that the inlet tube is in communication with the ventricle of the heart. When the inlet tube is inserted through the cannula1170, the hemostasis valve1162may assume an open position and may form a seal against the outer surface of the inlet tube.

FIG. 14Aillustrates an embodiment of an instrument1400for stabilizing an apical connector (which also may be referred to as a “heart connector” or a “tissue connector”) secured in a heart wall (which also may be referred to as a “tissue wall”). The instrument1400may be used, for example, to stabilize the apical connector during implantation of a VAD, particularly during attachment of the VAD to the apical connector. The instrument1400may be configured for use with the apical connector1100described above, including the valved cannula1170and the port1106, or any of the other connectors described herein or in the applications listed above.FIG. 14Billustrates an example method of using the instrument1400to stabilize the apical connector1100secured in the heart wall.

The instrument1400may include a handle1402and a connector interface1404attached to the distal end of the handle1402. The connector interface1404may be configured for removably attaching to an apical connector, such as the apical connector1100. As shown, the connector interface1404may include a pair of prongs1406(which also may be referred to as “arms”) having a C-shaped configuration and defining a U-shaped opening for receiving a portion of the connector1100. In particular, the prongs1406may be configured to receive a portion of the port1106therebetween, as shown inFIG. 14B. In this manner, the connector interface1404may be a port interface.

The connector interface1404also may include a stand-off feature1410configured to engage a portion of the connector1100. As shown, the stand-off feature1410may be a protrusion positioned about an intersection of the prongs1406and aligned with a center of the connector interface1404. In some embodiments, the stand-off feature1410may be configured to provide additional clearance between the connector1100and the VAD being attached thereto. The additional clearance may be for inserting locking mechanisms or the like. In some embodiments, the stand-off feature1410may be configured for insertion into a mating engagement feature of the connector1100. For example, the stand-off feature1410may be configured for insertion into one or more of the engagement notches1139of the port1106. As described above, the engagement notches1139may be configured for allowing the instrument1400to engage the port1106from a plurality of directions relative to the aperture1114of the port1106. For example, as shown inFIG. 14B, the notches1139may provide discrete engagement positions every 10 degrees about the circumferential outer surface of the port1106. The insertion of the stand-off feature1410into the mating engagement feature of the connector1100may provide the clearance desired for attachment of the VAD. Additionally, the engagement of the stand-off feature1410with the mating engagement feature of the connector1100may provide rotational stabilization of the connector1100relative to the instrument1400, thereby providing additional control and stabilization and also potentially reducing loads applied to the patient's heart during attachment of the VAD.

In some embodiments, portions of the instrument1400may be moldable or pliable such that portions of the instrument1400may be shaped or reshaped during a procedure, such as implantation of the VAD. For example, in some embodiments, the prongs1406may be manually reshaped or reconfigured as needed to better access a connector secured to the patient's heart. Additionally, in some embodiments, the handle1402may be reshaped depending on the size, orientation, and amount of clearance in the surgical field. For example, bends1414in the handle1402may be adjusted or straightened, as desired, to better accommodate the surgical field. Certain embodiments of tools that may be used to engage and stabilize ventricular cuffs secured to a heart are described in the '308 application. The instrument1400may have features and characteristics similar to those of the various embodiments of tools described in the '308 application and may be used according to methods similar to those described therein.

FIG. 15Aillustrates an embodiment of an instrument1500for allowing inspection of a ventricle of a heart through an apical connector (which also may be referred to as a “heart connector” or a “tissue connector”) secured in a heart wall (which also may be referred to as a “tissue wall”). The instrument1500may be used, for example, to allow visual and/or tactile inspection of the ventricle to identify any thrombus that may be present on an inner surface of the heart wall and to facilitate removal of such thrombus. The instrument1500may be configured for use with the apical connector1100described above, including the valved cannula1170and the port1106, or any of the other connectors described herein or in the applications listed above.FIG. 15Billustrates an example method of using the instrument1500to allow inspection of a ventricle of a heart through the apical connector1100secured in a heart wall.

In certain embodiments, the outer diameter (OD) of the instrument1500is dimensioned and configured to correspond to the valve1162and/or the aperture1114of the port1106. In certain embodiments, the inner diameter (ID) of the instrument1500is dimensioned and configured to correspond to an instrument to be received therethrough. In certain embodiments, the ID is dimensioned and configured to provide a lumen for visual inspection therethrough.

The instrument1500may be formed as a substantially tube-shaped member configured for positioning at least partially through an apical connector, such as the apical connector1100, and at least partially through a heart wall in which the apical connector is secured. As shown, the instrument1500may include a main tube1502defining an aperture1504therethrough, and a proximal flange1506fixedly attached to the main tube1502. The main tube1502may be configured for insertion within the cannula1170such that the hemostasis valve1162opens and forms a substantially fluid-tight seal along the outer circumferential surface of the main tube1502. The leading edge of the main tube1502may be rounded to reduce the risk of damaging the leaflets of the valve1162when they are pushed open. The aperture1504of the main tube1502may be configured to allow insertion of a clinician's finger or a separate instrument therethrough for tactile inspection of the ventricle of the heart. The aperture1504also may allow for visual inspection of the ventricle. The proximal flange1506may be configured for abutting the proximal end of the connector1100, such as the proximal end of the cannula1170, thereby limiting insertion of the main tube1502within the cannula1170and stabilizing the instrument1500with respect to cannula1170and the overall connector1100. In some embodiments, the proximal flange1506may be positioned at the proximal end of the main tube1502, as shown. In other embodiments, the proximal flange1506may be positioned near but offset from the proximal end of the main tube1502.

FIG. 15Bshows the instrument1500in a fully inserted position with respect to the apical connector1100, in which the proximal flange1506abuts the proximal end of the cannula1170, and the main tube1502is positioned at least partially within the cannula1170. As shown, the main tube1502may extend into the cannula1170such that the hemostasis valve1162opens and forms a substantially fluid-tight seal along the outer circumferential surface of the main tube1502. In some embodiments, the distal end of the main tube1502may be positioned within the cannula1170when the instrument1500is in the fully inserted position. In other embodiments, the distal end of the main tube1502may extend distally beyond the distal end of the cannula1170when the instrument1500is in the fully inserted position. With the instrument1500in the fully inserted position, a clinician may visually inspect the ventricle through the aperture1504and/or may insert a finger or a separate instrument through the aperture for tactile inspection of the ventricle. In particular, the clinician may use the instrument1500to identify any thrombus that may be present on an inner surface of the heart wall and to remove any thrombus that may compromise operation of a VAD implanted via the connector1100. After inspection of the ventricle and removal of any thrombus, the instrument1500may be removed from the apical connector1100. As the main tube1502is removed from the cannula1170, the hemostasis valve1162may close to prevent blood loss through the connector1100.

In some embodiments, as shown, the outer diameter of the proximal flange1506may be approximately equal to the outer diameter of the apical connector1100. In this manner, the proximal flange1506may cover and protect the connector1100during inspection. Additionally, such sizing of the proximal flange1506may allow a clinician to use the instrument1500, prior to securing the apical connector1100to the heart wall, as a template to approximate positioning of the port1106and/or the sewing ring1193on the heart wall. In some embodiments, the outer diameter of the proximal flange1506may be approximately equal to the outer diameter of the anchoring device1102. Such sizing of the proximal flange1506may allow a clinician to use the instrument1500, prior to securing the apical connector1100to the heart wall, as a template to approximate positioning of the anchoring device1102within the heart wall.