Patent Description:
The disclosed subject matter is directed to medical devices for endovascular, percutaneous or minimally invasive surgical treatment of bodily tissues, such as tissue approximation or valve repair. More particularly, the present disclosure relates to repair of valves of the heart and venous valves.

Surgical repair of bodily tissues can involve tissue approximation and fastening of such tissues in the approximated arrangement. When repairing valves, tissue approximation includes coapting the leaflets of the valve in a therapeutic arrangement which can then be maintained by fastening or fixing the leaflets. Such coaptation can be used to treat regurgitation, which commonly occurs in the mitral valve and in the tricuspid valve.

Mitral valve regurgitation is characterized by retrograde flow from the left ventricle of the heart through an incompetent mitral valve into the left atrium. During a normal cycle of heart contraction (systole), the mitral valve acts as a check valve to prevent flow of oxygenated blood from the left ventricle back into the left atrium. As such, as the left ventricle contracts, the oxygenated blood is pumped from the left ventricle into the aorta through the aortic valve. Regurgitation of the mitral valve can significantly decrease the pumping efficiency of the heart, placing the patient at risk of severe, progressive heart failure.

Mitral valve regurgitation can result from a number of different mechanical defects in the mitral valve or the left ventricular wall. The valve leaflets, the valve chordae connecting the leaflets to the papillary muscles, the papillary muscles, or the left ventricular wall can be damaged or otherwise dysfunctional. Commonly, the valve annulus can be damaged, dilated, or weakened, limiting the ability of the mitral valve to close adequately against the high pressures of the left ventricle.

Treatments for mitral valve regurgitation can involve valve replacement or repair including leaflet and annulus remodeling, the latter generally referred to as valve annuloplasty. Another technique for mitral valve repair, which can be referred to as the "bow-tie" or "edge-to-edge" technique, can involve suturing adjacent segments of the opposed valve leaflets together. Preferably, devices and systems for mitral valve repair can be utilized without open chest access, and, rather, can be capable of being performed endovascularly, i.e., delivering fixation devices (e.g., a valve repair clip) using delivery systems advanced to the heart from a point in the patient's vasculature remote from the heart. During endovascular procedures, the fixation devices delivered to the heart can be operated remotely (i.e., from outside the patient's body), for example, the fixation devices can be opened and closed. Additionally, the devices and systems can typically lock the fixation device into a fixed position and unlock the fixation device to allow repositioning (and/or removal if desired), for example, using a lock line extending from the handle (i.e., outside the patient) to the fixation device. Once the tissue has been satisfactorily approximated, the fixation system can be left behind as an implant. As such, there remains a need for ergonomic control of the lock line and release of the lock line to leave the fixation device behind for implantation. <CIT> discloses devices, systems and methods for tissue approximation and repair at treatment sites.

The extent of protection is defined by the scope of the claims which recite a medical delivery system for delivering a medical implant. The purpose and advantages of the disclosed subject matter will be set forth in and apparent from the description that follows, as well as will be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the systems and methods particularly pointed out in the written description and claims hereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purpose of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter is directed to a medical delivery system including a locking system.

In accordance with the disclosed subject matter, a medical delivery device system for delivering a medical implant is provided. The medical device delivery system includes a catheter, handle, lock line handle, and lock line. The catheter includes a proximal end portion and a distal end portion. The handle is coupled to the proximal end portion of the catheter. The lock line handle is releasably coupled to the handle and actuatable between a lock position and an unlock position. The lock line includes a first end portion fixedly coupled to the lock line handle, a second end portion releasably coupled to the lock line handle, and an intermediate portion configured to be releasably coupled to the medical implant disposed proximate the distal end portion of the catheter. Actuating the lock line handle from the lock position toward the unlock position increases tension on the lock line, and actuating the lock line handle from the unlock position toward the lock position decreases tension on the lock line.

In accordance with the disclosed subject matter, the system can include a lock assembly to selectively secure the lock line handle in each of the lock position and unlock position. The lock assembly can include at least one of audible and tactile feedback upon locking. The lock assembly can include a latch-detent lock. The latch of the latch-detent lock can be spring-biased towards a lock position.

In accordance with the disclosed subject matter, the lock line handle can be configured to pivot relative the handle to actuate between the lock position and the unlock position. The lock line handle can include a spool to receive the lock line. The first end portion of the lock line can be coupled to the lock line handle by a swivel-head set screw. The lock line handle can include a pear shape. The lock line handle can be releasably coupled to the handle by one of a snap fit, clip, slide-release, and button-release.

The lock line handle can be configured to translate linearly relative the handle to actuate between the lock position and the unlock position. The lock position can be located distally from the proximal position. The lock line handle can include a T-shape. The lock line handle can include a thumb slide.

The lock line handle can be actuatable from the unlock position toward a third position to further increase tension on the lock line beyond the tension on the lock line in the unlock position. The system can include an override mechanism to selectively prevent activation of the lock line handle from the unlock position to the third position. The second end portion of the lock line is configured to be release when the lock line handle is released from the handle.

In accordance with the disclosed subject matter, the catheter can define at least one lumen extending between the proximal end portion and the distal end portion. The system can include a shaft having a proximal end portion and a distal end portion, and the shaft can extend through the at least one lumen. The medical implant can be releasably coupled to the distal end portion of the shaft. The system can include an outer catheter having a proximal end portion coupled to the handle and a distal end portion, the outer catheter defining at least one outer-catheter lumen extending between the proximal end portion and the distal end portion; wherein the catheter extends through the outer-catheter lumen.

The medical implant can be an implantable fixation device. The implantable fixation device can include a first arm moveable between a first position and a second position, and a second arm moveable between a first position and a second position. When the lock line handle is in the lock position the first arm and the second arm can be restricted at least from moving from the respective first positions toward the respective second positions. When the lock line handle is in the lock position the first arm and the second arm can move from the respective second positions toward the respective first positions. When the lock line handle is in the unlock position the first arm and the second arm can be moved freely between the respective first positions and second positions. The implantable fixation device can include a first gripping element movable relative to the first arm; and a second gripping element movable relative to the second arm.

Reference will now be made in detail to the various exemplary embodiments of the disclosed subject matter, exemplary embodiments of which are illustrated in the accompanying drawings.

Generally, and as set forth in greater detail below, the disclosed subject matter provided herein includes a medical device delivery system for delivering a medical implant, such as a fixation device. The medical device delivery system includes a catheter, handle, lock line handle, and lock line. The catheter includes a proximal end portion and a distal end portion. The handle is coupled to the proximal end portion of the catheter. The lock line handle is releasably coupled to the handle and actuatable between a lock position and an unlock position. The lock line includes a first end portion fixedly coupled to the lock line handle, a second end portion releasably coupled to the lock line handle, and an intermediate portion configured to be releasably coupled to the medical implant disposed proximate the distal end portion of the catheter. Actuating the lock line handle from the lock position toward the unlock position increases tension on the lock line, and actuating the lock line handle from the unlock position toward the lock position decreases tension on the lock line.

The medical device delivery system of the disclosed subject matter can be used for edge-to-edge transcatheter valve repair for patients having various conditions, including regurgitant mitral valves or tricuspid valves. Although described with respect to edge-to-edge repair, the medical device delivery system of the disclosed subject matter can be used with a wide variety of suitable transcatheter delivery systems. Transcatheter (e.g., trans-septal) edge-to-edge valve repair has been established using a fixation device, such as the MitraClip Transcatheter Mitral Valve Repair device. These fixation devices generally are configured to capture and secure opposing native leaflets using two types of leaflet contacting elements. The first element is a sub-valvular arm (also known as a distal element or fixation element) to contact the ventricular side of a native leaflet to be grasped. With the arm positioned underneath to stabilize the native leaflet in a beating heart, a second gripping element (also known as a proximal element) can be lowered or moved into contact with the atrial side of the native leaflet to capture the leaflet therebetween. Once each opposing leaflet is captured by a respective arm and gripper element, the fixation device can be closed by moving the arms toward a center of the fixation device such that the leaflets are brought into coaptation, which results in a reduction in valvular regurgitation during ventricular systole. Furthermore, a covering can be provided on the arms and/or gripper elements to facilitate tissue ingrowth with the captured leaflets. Such fixation devices can be delivered to the mitral valve using a delivery system. The delivery system can include control features including, among other things, a locking feature for allowing or inhibiting motion of the distal elements.

Additional details of exemplary fixation devices and delivery systems in accordance with the disclosed subject matter are set forth below. Furthermore, various patents and published applications disclose additional details of such fixation devices and delivery systems and related operations, for example, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>,<CIT>, and<CIT>.

Referring to <FIG> for purpose of illustration and not limitation, an exemplary fixation device <NUM> for fixation of native leaflets of a heart valve is disclosed herein. The fixation device as depicted can include at least gripping elements <NUM> and arms <NUM> which can protrude radially outward and can be positionable on opposite sides of tissue, such as leaflets, so as to capture or retain the leaflets therebetween at a single location or along a continuum or range of positions as desired by the user. The gripping elements <NUM> can be manipulated by gripping element lines 90A, 90B. That is, the gripping elements <NUM> can be raised and lowered by increasing or decreasing tension on the gripping element lines 90A, 90B. The fixation device <NUM> is couplable to the shaft of a delivery system (not shown) by a coupling mechanism, a portion of which is shown as coupling member <NUM>. Although a specific arrangement of gripping element lines 90A, 90B, is shown, any suitable arrangement can be used. For example, a single gripping element line manipulate gripping element <NUM>. The coupling mechanism can allow the fixation device <NUM> to detach and be left behind as an implant to hold the leaflets together in the coapted position. The coupling member <NUM> can be formed with or connected to housing <NUM>, which can house locking mechanism <NUM>.

The fixation device <NUM> can include a locking mechanism <NUM> for locking the device <NUM> in a particular position, such as an open, closed, or inverted position, or any position therebetween. In accordance with the disclosed subject matter, the locking mechanism <NUM> can include an unlocking mechanism which can allow the device to be both locked and unlocked. The locking mechanism <NUM> can be disposed between the coupling member <NUM> and the base <NUM> of the actuation mechanism <NUM>. The base <NUM> can be connected to the legs <NUM> of the actuation mechanism <NUM> which can be connected to arms <NUM>. Thus, movement of the legs <NUM> can move the arms <NUM> through open, closed and inverted positions. The base <NUM> can also be fixedly attached to stud <NUM> which can extend through the locking mechanism <NUM>. The stud <NUM> can be releasably attached to an actuator rod <NUM> which passes through coupling member <NUM> and the shaft of the delivery system. Release of the stud <NUM> from the actuator rod <NUM> allows the fixation device <NUM> to be detached and left behind as an implant.

Lock line <NUM> is connected with release harness <NUM> of the locking mechanism <NUM>. The lock line <NUM> can lock and unlock the locking mechanism <NUM> as described in greater detail below. The gripping element lines 90A, 90B and lock line <NUM> can be any suitable material, including wire, nitinol wire, cable, suture or thread. Additionally, gripping element lines 90A, 90B and/or lock line <NUM> can includes a coating, such as a Parylene®. Parylene® is a vapor deposited pinhole free protective film which is conformal and biocompatible. It is inert and can protect against moisture, chemicals, and electrical charge.

Referring to <FIG> for purpose of illustration and not limitation, an exemplary locking mechanism <NUM> is provided. The locking mechanism <NUM> can include a binding lever or binding plate <NUM>. As shown in <FIG>, for purpose of illustration and not limitation, binding plate <NUM> can have an oblong shape extending between a first end <NUM> and a second end <NUM> with a bottom plan surface <NUM> and a top planar surface <NUM>. An aperture <NUM> can be formed between the first and second ends <NUM>, <NUM> extending from the top planar surface <NUM> through to the bottom planar surface <NUM>. The binding plate <NUM> can be positioned within the locking mechanism <NUM> so that the stud <NUM> passes through the aperture <NUM>. The first end <NUM> can be positioned within a notch <NUM> which can prevent axial movement of the first end <NUM>. However, the second end <NUM> can be free to move in an axial direction, thereby creating a lever type movement of the binding plate <NUM>. Movement of the second end <NUM> can be controlled by the associated hooked end <NUM> of the release harness <NUM>. When an upwards force is applied to the harness <NUM> by the lock line <NUM>, the hooked end <NUM> raises the second end <NUM> of the plate <NUM> against a spring <NUM> so that the planar surfaces <NUM>, <NUM> are substantially perpendicular to the stud <NUM>. This aligns the aperture <NUM> with the stud <NUM> allowing free movement of the stud <NUM>. Thus in this state, the locking mechanism <NUM> is unlocked wherein the stud <NUM> is free to move the actuation mechanism <NUM> and therefore the arms <NUM> to any desired position.

Release of the harness <NUM> by the lock line <NUM> can transition the locking mechanism <NUM> to a lock position. By releasing the upwards force on the second end <NUM> of the binding plate <NUM>, the spring <NUM> can force the second end <NUM> downwards and can wedge the aperture <NUM> against the stud <NUM>. This can restrict motion of the stud <NUM>, which in turn can lock the actuation mechanism <NUM> and therefore arms <NUM> in place. Binding plate <NUM> can have any suitable form to function as described hereinabove. For example, the plate <NUM> can include a variety of shapes with or without planar surfaces <NUM>, <NUM> and/or aperture <NUM> can be of a variety of shapes and positioned in a variety of locations. Further, any number of binding plates <NUM> can be present. Each binding plate <NUM> can provide an additional biding location which can enhance lock performance.

Although this disclosures describes specific designs for the binding plate <NUM>, any suitable binding plate <NUM> is contemplated. For example, the binding plate <NUM> can be shaped without an aperture <NUM>. In such embodiments, the binding plate <NUM> can be shaped to at least partially surround the stud <NUM>, such as having a notch, inlet or hook-shape through which the stud <NUM> can pass. Thus, the binding plate <NUM> can function in the same manner as described above wherein the portion at least partially surrounding he stud <NUM> can engages the stud <NUM> for locking and disengages the stud <NUM> for unlocking.

The biding plate <NUM> and the stud <NUM> can be any suitable materials. For example, binding plate <NUM> can have a higher hardness than the stud <NUM>. Alternatively, binding plate <NUM> can include a flexible or semi-flexible material. Such flexibility can allow a slight movement of the stud <NUM> in the proximal and distal directions, therefore allowing slight movement of the arms <NUM> when the locking mechanism is in the lock position. Although this application This can allow the fixation device <NUM> o adjust in response to dynamic cardiac forces.

Locking mechanism <NUM> can allow the fixation device <NUM> to be incrementally moved toward the closed position while locked. Movement toward the closed position is achieved by retracting or pulling the stud <NUM> in the proximal direction so that the arms <NUM> approach each other. Retraction of the stud <NUM> draws the binding plate <NUM> toward a horizontal position, aligning the aperture with the stud <NUM> and thus allowing movement. In contrast, extension or pushing of stud <NUM> in the distal direction can be resisted by further wedging the binding plate <NUM> against the stud <NUM>. Once the final placement is determined, the lock line <NUM> and proximal element lines 90A, 90B can be removed and the fixation device can be left behind. Although this disclosure describes specific designs for the lock mechanism, any suitable lock mechanism is contemplated. Additional details and exemplary locking mechanisms are provided in <CIT>.

Referring to <FIG> for purpose of illustration and not limitation, an exemplary delivery device <NUM> is provided for delivery of a fixation device as disclosed. That is, the delivery device <NUM> can be used to introduce and position a fixation device as described above. The delivery device <NUM> can include a shaft <NUM>, having a proximal end <NUM> and a distal end <NUM>, and a handle <NUM> attached to the proximal end <NUM>. A fixation device (not shown) can be removably coupleable to the distal end <NUM> for delivery to a site within the body, for example, the mitral valve. Thus, extending from the distal end <NUM> is a coupling structure <NUM> for coupling with a fixation device <NUM>. Also extending from the distal end <NUM> is an actuator rod <NUM>. The actuator rod <NUM> is connectable with the fixation device <NUM>, for example to stud <NUM>, and can act to manipulate the fixation device <NUM>, for example, opening and closing the arms <NUM>. Handle <NUM> of the delivery device <NUM> is shown, including main body <NUM>, proximal element line handle <NUM>, the lock line handle <NUM>, the actuator rod control <NUM> and the actuator rod handle <NUM>, among other features. The handle <NUM> is supported by the support base <NUM> which is connected to handle <NUM> (see <FIG>).

Lock line (or lines) <NUM> can pass through at least one lumen of shaft <NUM> between the lock line handle <NUM> and the locking mechanism <NUM>. The lock line <NUM> can engage the release harness <NUM> of the locking mechanism <NUM> to lock and unlock the locking mechanism <NUM> as described above. The lock line <NUM> can engage the release harness <NUM> in various arrangements, for example, as shown in <FIG>. Additional details and exemplary lock line coupling with the fixation device <NUM> is provided in <CIT>.

Referring to <FIG> and <FIG> for purpose of illustration and not limitation, actuator rod handle <NUM>, actuator rod control <NUM>, gripping element line handle <NUM>, and lock line handle <NUM> can all be joined with the main body <NUM> of handle <NUM>. The handle <NUM> can include a support base <NUM> connected with the main body <NUM>. The main body <NUM> can be slidable along the support base <NUM> to provide translation of the shaft <NUM> and the main body <NUM> is rotateable around the support base <NUM> to rotate the shaft <NUM>.

<FIG> provides a partial cross-sectional view of body <NUM> of the handle <NUM> depicted in <FIG>. As shown in <FIG>, the main body <NUM> can include a sealed chamber <NUM> within which the actuator rod <NUM>, gripping element lines 90A, 90B, and lock line <NUM> can be guided into the shaft <NUM>. The sealed chamber <NUM> can be in fluid communication with the inner lumen of the shaft <NUM> and can be filed with saline and flushed with heparin or heparinized saline. The sealed chamber <NUM> can have a seal <NUM> along its perimeter to prevent leakage and the introduction of air to the chamber <NUM>. Air can be bled from the chamber <NUM> by one or more luers <NUM> which pass through the main body <NUM> into the chamber <NUM> as illustrated in <FIG>. As shown in <FIG>, the handle <NUM> can include two luers <NUM>, one on each side of the main body <NUM> (the second luer is hidden from view in <FIG>). The sealed chamber <NUM> can also have various additional seals, such as an actuator rod seal <NUM> which can surround the actuator rod <NUM> where the actuator rod <NUM> enters the sealed chamber <NUM>, and a shaft seal <NUM> which can surround the shaft <NUM> where the shaft <NUM> enters the sealed chamber <NUM>.

Lock line <NUM> can be extended, retracted, loaded with various amounts of tension, or removed using the lock line handle <NUM>. Likewise, gripping element lines 90A, 90B can be extended, retracted, loaded with various amounts of tension, or removed using the gripping element line handle <NUM>. Although particular handle <NUM> including lock line handle <NUM> and gripping element line handle <NUM> are shown in <FIG>, a variety of designs can be implemented to manipulate the appropriate lines.

Referring to <FIG>, for purpose of illustration and not limitation, handle <NUM> can include one or more features described above with regard to handles. For example, handle <NUM> can include a main body <NUM>, a lock line handle <NUM>, gripping element line handles 3312A, 3312B, and actuator rod handle <NUM>. The gripping element line handles 3312A, 3312B can be used to independently operate each gripping element line 90A, 90B (<FIG>), respectively. Additional details and exemplary gripping element line handles are provided in <CIT>, the entirety of the contents of which is incorporated herein by reference. Actuator rod handle <NUM> can operate the actuator rod <NUM>. Lock line handle <NUM> can operate lock line <NUM>. Lock line handle <NUM> can be releasably coupled to the main body <NUM>. Lock line <NUM> can have a first end portion 92A (<FIG>) fixedly coupled to the lock line handle <NUM> and a second end portion 92B (<FIG>) releasably coupled to the lock line handle <NUM>. An intermediate portion 92C (<FIG>) of the lock line <NUM> can be configured to engage the release harness <NUM> in various arrangements, for example, as shown in <FIG>.

As shown in <FIG>, for purpose of illustration and not limitation, the handle <NUM> and lock line handle <NUM> can include a number of elements to allow the lock line handle <NUM> to operate properly, including, for example, operating the lock line <NUM> and releasing from the handle <NUM>. <FIG> shows a perspective view the lock line handle <NUM> and related elements of the handle <NUM>; <FIG> shows an exploded view. In accordance with the disclosed subject matter, lock line handle <NUM> can include lock knob 3310A, which can be gripped by a user and pivoted relative handle <NUM> to operate the lock line <NUM> (as described in greater detail below). The lock knob 3310A can have a pear shape which can act as a flag in the unlock position to indicate to a user that the fixation device <NUM> is unlocked (see e.g., <FIG>). Although shown as a pear shape, lock knob 3310A can have any suitable shape and/or configuration. Lock knob cap 3310B can be coupled to the lock knob 3310A. Screw cap 3310C can be coupled to shaft 3310D, for example via threading or other known means. Lock knob insert 3310E can be coupled lock knob shaft 3310D and lock knob 3310A. For example, a portion of the lock knob insert 3310E can be received within the lock knob 3310A. The pear shape of the lock knob 3310A and the received portion of the lock knob insert 3310E can limit relative rotation between the lock knob insert 3310E and the lock knob 3310A. Enmeshed gears of the lock knob insert 3310E and the lock knob shaft 3310D can limit relative rotation between the lock knob insert 3310E and the lock knob shaft 3310D. Furthermore, the gears can permit specific tensions or slack to be set on lock line <NUM>. The tension needed can be different from device to device, but the gears can allow the lock knob 3310A to be aligned in a similar orientation relative the handle <NUM> from device to device. As such, the lock position and the unlock position can be consistent from device to device. Rotation of the lock knob 3310A can cause rotation of the lock knob insert 3310E, and thereby cause rotation of the lock knob shaft 3310D. The lock knob insert 3310E can include a plurality of detents <NUM> and a channel 3310I. Hairpin clip 3310F can be inserted between the lock knob 3310A and lock knob cap 3310B, proximate the screw cap 3310C to prevent disassembly of the lock line handle <NUM> when in place, and can allow disassembly of the lock line handle <NUM> when removed, for example, in case of malfunction. O-rings <NUM> can be provided on the shaft 3310D. The O-rings <NUM> can be any suitable O-rings, for example, -<NUM> O-rings.

Handle <NUM> can include lock knob volume 3304F, which can receive the lock knob shaft 3310D of the lock line handle <NUM>. Handle <NUM> can include a locking system to limit movement of the lock line handle <NUM> relative the handle <NUM> and removal of the lock line handle <NUM> relative the handle <NUM>. The lock system can be a latch-detent lock. For example, the latch can include a distal U-lock 3304A and a proximal U-lock 3304B coupled to one another (and collectively referred to as the "U-lock") and configured to surround lock knob volume 3304F. The proximal U-lock 3304B can include pin 3304C which can engage detents <NUM> on the lock knob insert 3310E, when the pin 3304C is insert through window <NUM> disposed in the lock knob volume 3304F. The distal U-lock 3304A can include a rail 3304T to engage the channel 3310I on the lock knob insert 3310E. The locking system can further include delivery catheter ("DC") handle insert 3304D and release slider 3304E, which can be used to release the lock knob <NUM>. The DC handle insert 3304D can include an indication, for example, an icon (such as a lock) or writing, to indicate that the DC handle insert 3304D and the release slider 3304E are intended to lock the lock line handle <NUM>. For example, and not by way of limitation, release slider 3304E can include a pin 3304R that can engage the proximal U-lock 3304B (for example, through a window in DC handle insert 3304D). Spring 3304N can be supported on pin <NUM> of the lock knob volume 3304F, and can bias the latch into the lock position. That is, the spring can bias the latch in a distal direction to cause the pin 3304C to engage the detents <NUM>. Engagement of the pin 3304C with the detents <NUM> can provide feedback, for example, audible and/or tactile, for a user that the lock knob 3310A has reached a specific position (e.g., lock, unlock, override (also referred to herein as the third position)). Pin 3304C and detents <NUM> can be arranged such that the lock knob 3310A will not move from a specific position (e.g., lock, unlock, override), however, a user can move the lock knob 3310A (i.e., overcome the engagement between the pin 3304C and the detents <NUM>) by turning the knob, and without touching the release slider 3304E. A portion of the distal U-lock 3304A, for example, the rail 3304T on the distal U-lock 3304A and channel 3310I can be arranged such that the lock line handle <NUM> can be removed from the handle <NUM> when the distal U-lock 3304A is disengaged from the channel 3310I. For example, a user can slide the release slider 3304E to disengage the distal U-lock 3304A from the channel 3310I and thereby release the lock line handle <NUM>. For example, sliding the release slider 3304E in the proximal direction can disengage the rail 3304T on the distal U-lock 3304A from the channel 3310I and thereby permit the user to pull the lock line handle <NUM> from the handle <NUM>. Although a particular locking system is described, any suitable locking system can be used to limit movement of the lock knob <NUM> between the lock, unlock, and override positions, and to prevent unintentional removal of the lock line handle <NUM> from the handle <NUM>.

Lock knob volume 3304F can house the spool 3304I, about which the lock line <NUM> can be wrapped to provide tensile load on the lock line <NUM>. The spool 3304I can be rotationally fixed relative the lock knob shaft 3310D, for example, by a keying feature, enmeshed gears, or any suitable means. Accordingly, rotation of the lock knob 3310A, which can cause rotation of the lock knob shaft 3310D, can thereby cause rotation of the spool 3304I and therefore increase or decrease tensile load on the lock line <NUM> by way of the lock line <NUM> spooling or unspooling around the spool 3304I. The lock knob volume 3304F can include a dowel pin 3304Q. The first end portion 92A of the lock line <NUM> can be routed around the dowel pin 3304Q and fin 3304U in the lock knob volume 3304F. This can align the first end portion 92A of the lock line <NUM> with the spool 3304I and can manage slack in the first end portion 92A of the lock line <NUM>. If slack is not managed, the first end portion 92A of the lock line <NUM> can disengage from the spool 3304I. Lock knob volume lid 3304J can close the lock knob volume 3304F, and can receive a luer fitting, or similar. O-ring retainer <NUM> can have a hole through which the lock line <NUM> can extend. The handle <NUM> can include mandrel seal retainer <NUM> and mandrel seal <NUM>, and O-rings, <NUM>, 3304P, which can be, for example, a -<NUM> O-ring and a - <NUM> O-ring, respectively. Although a specific arrangement for loading and unloading the lock line <NUM> is provided, any suitable means of loading and unloading the lock line <NUM> can be used.

As shown in <FIG> and <FIG>, for purpose of illustration and not limitation, the first end portion 92A and the second end portion 92B of the lock line <NUM> can extend through O-ring retainer <NUM>. As noted above, the first end portion 92A can be routed around the dowel pin 3304Q and relative fin 3304U, and routed around spool 3304I. The first end portion 92A can further extend within the lock knob shaft 3310D and can be fixedly coupled to the lock line handle <NUM>, for example, by screw cap 3310C. For example, the first end portion 92A can extend through the lock knob shaft 3310D and then be wrapped around lock knob shaft 3310D (<FIG>). The screw cap 3310C can be coupled to the lock knob shaft 3310D (<FIG>) to fixedly couple the first end portion 92A to the lock line handle <NUM>. The second end portion 92B can be releasably coupled to the lock line handle <NUM>. For example, second end portion 92B can extend into the spool 3304I and between the spool 3304I and lock knob shaft 3310D to trap ("sandwich") the second end portion 92B therebetween. Accordingly, when the lock line handle <NUM> is coupled with the handle <NUM>, the second end portion 92B can be releasably coupled to the lock line handle <NUM>, and when the lock line handle <NUM> is decoupled (released) from the handle <NUM>, the second end portion 92B can be decoupled (released) from the lock line handle <NUM>. Although, described with specific arrangements for fixedly and releasably coupling the first end portion 92A and second end portion 92B of the lock line <NUM>, respectively, any suitable arraignments for fixedly and releasably coupling the respective end portions can be used.

The system can be flushed via a port in a fluid management system <NUM> (<FIG>). For example, flush fluid can enter the lock knob volume 3304F from the distal end through the O-ring retainer <NUM>. During preparation of the device, air can exit the device through a luer port in the lock knob volume lid 3304J. When de-airing is complete, a cap <NUM> can be placed on the luer port. The cap <NUM> can be a red cap <NUM>, which can be easily noticed by a user, however, any suitable cap shape and/or color can be used. As noted, O-rings (e.g., 3304P, <NUM>) and mandrel seal <NUM> can keep hemostasis throughout the procedure. Although fluid flushing and de-airing is described in a particular arrangement, any suitable arrangement can be used for flushing and de-airing.

In operation, the fixation device <NUM> can be delivered in a lock position (as described above). The lock knob 3310A can be in the lock position, which is shown for example, in <FIG> and <FIG>. In the lock position, the lock line <NUM> can have no (or relatively low) tension and the lock knob 3310A can point distally. Spring 3304N can bias distal U-lock 3304A and proximal U-lock 3304B in a distal direction and therefore bias pin 3304C to engage detent <NUM> of the lock knob insert 3310E (<FIG>). Although described in a particular arrangement, the lock position can include any suitable arrangement.

During a procedure, the user can turn the lock knob 3310A to the unlock position to apply tension (or relatively higher tension) to the lock line <NUM>. Turning the lock knob 3310A can overcome the engagement of the pin 3304C with detent <NUM>. For example, the lock knob 3310A can be rotated in a clockwise rotation (as viewed in <FIG>) such that the lock knob 3310A can point upwardly (<FIG>). In such a position, the lock knob 3310A itself can indicate to the user that the fixation device <NUM> is in the unlock position. Rotating the lock knob 3310A can cause spool 3304I to rotate (as described above) and can increase tension on the lock line <NUM> as the lock line <NUM> spools around the spool 3304I. As noted above, increasing tension on lock line <NUM> can apply a force on harness <NUM> which can unlock the fixation device <NUM>, as described above. Spring 3304N can bias distal U-lock 3304A and proximal U-lock 3304B in a distal direction and therefore bias pin 3304C to engage detent <NUM> of the lock knob insert 3310E (<FIG>) and bias the rail 3304T on the distal U-lock 3304A to engage the channel 3310I of the lock knob insert 3310E. The detents <NUM> (as well as labeling) can define the lock and unlock positions. A click sound can be made as the pin 3304C engages detent <NUM>. The detent <NUM> can also prevent the lock knob 3310A from returning to the lock position (until a user engages the lock knob 3310A). Although described in a particular arrangement, the unlock position can include any suitable arrangement. The user can lock the fixation device <NUM> by rotating the lock knob 3310A in the counterclockwise direction (as viewed in <FIG>) to return the lock knob to the lock position, unspool the lock line <NUM> from spool 3304I, and decrease tension on lock line <NUM>. A click sound can be made as the pin 3304C engages detent <NUM><NUM>. The rail 3304T can remain engaged with the channel <NUM> even as the handle moves between the lock, unlock, and third position. Although a particular method of operating the lock line handle is described, and suitable method of operating the lock line handle can be used to increase or decrease tension on lock line <NUM>.

The lock knob 3310A can be rotated beyond the unlock position (see e.g., <FIG>), to a third position, and to thereby further increase tension on the lock line <NUM>. This can be useful during certain procedures to ensure that the fixation device <NUM> properly locks. Additional detents <NUM> can be provided to engage the pin 3304C and hold the lock knob 3310A in the third position or further rotated positions. The rail 3304T can remain engaged with the channel <NUM> even as the handle moves between the lock, unlock, and third positions. Although described in a particular arrangement, the third position, and any further positions, can include any suitable arrangement.

Before the fixation device <NUM> can be deployed from the delivery device <NUM>, the lock line <NUM> must be decoupled from the fixation device <NUM>. To remove the lock line <NUM>, the user can ensure that the lock knob 3310A is in the lock position. The user can retract the release slider 3304E (i.e., the release slider can be pulled in the proximal direction). This can pull the proximal U-lock 3304B (for example via pin 3304R) and the distal U-lock 3304A in a proximal direction (<FIG>), which can disengage the rail 3304T of the distal U-lock 3304A from channel 3310I. The user can pull the lock line handle <NUM> off the handle <NUM> (<FIG>). Withdrawing the lock line handle <NUM> can release the second end portion 92B of lock line <NUM> from between the spool 3304I and lock knob shaft 3310D, while the first end portion 92A remains fixed to the lock line handle <NUM>. Accordingly, withdrawing the lock line handle <NUM> pulls one end portion of the lock line <NUM> (i.e., first end portion 92A), while the other end portion (i.e., the second end portion 92B) is free to travel distally along the length of the shaft <NUM>, through the fixation device <NUM>, and proximally along the length of the shaft <NUM>. Therefore, pulling the lock line handle <NUM> away from the handle <NUM> with withdraw the lock line from the delivery system <NUM> and fixation device <NUM>.

If the first end portion 92A of the lock line <NUM> becomes stuck, the user can disassemble the lock line handle <NUM> (<FIG>). For example, the user can remove hairpin clip 3310F and remove the lock knob 3310A and lock knob insert 3310E from the lock knob shaft 3310D. The user can then unscrew screw cap 3310C from the lock knob shaft 3310D. This can provide access the first end portion 92A. The user can pull the second end portion 92B of the lock line <NUM> to pull to free the "stuck" first end portion 92A. Although a particular method of disassembling the handle is described, any suitable method for disassembling the handle can be used.

In accordance with the disclosed subject matter, a variety of lock line handle designs can be used to operate, release, and retract the lock line <NUM>. For example, and with reference to <FIG> for purpose of illustration and not limitation, handle <NUM> can have any of the features described herein above related to handles. For example, handle <NUM> can include main body <NUM>, lock line handle <NUM>, gripping element line handle <NUM>, and actuator rod handle <NUM>. Lock line handle <NUM> can include slider <NUM>, which can be, for example, a thumb slide. Lock line <NUM> (not shown) can extend from slider <NUM> to the harness <NUM> of fixation device <NUM>. The slider <NUM> can be moveable between a lock (e.g., forward, distal) position (<FIG>) and an unlock (e.g., retracted, proximal) position (<FIG>). Slider <NUM> can be slidable between the lock and unlock positions (<FIG>). Moving slider <NUM> from the lock position toward the unlock position can increase tension on the lock line <NUM>, and therefore apply a force on harness <NUM> which unlocks the fixation device <NUM>, as described above. Moving slider <NUM> from the unlock position toward the lock position can reduce tension on the lock line <NUM>, and therefore reduce the force on harness <NUM> which locks the fixation device <NUM>, as described above. Slider <NUM> can include a lock assembly, for example, a latch-detent lock, to audibly and/or tactically indicate to the user that the slider <NUM> has reached the lock or unlock position. For example, slider <NUM> can include latch <NUM>, which can be received in detent 2332A in the lock position and detent 2332B in the unlock position. Spring <NUM> can ensure that latch <NUM> engages detents 2332A, 2332B as slider <NUM> slides relative the lock and unlock positions. Slider <NUM> can include an ergonomic shape for receiving a user's thumb or finger to push slider <NUM> and release latch <NUM> from detents 2332A, 2332B. Additionally, slider <NUM> can include an override mechanism to selectively prevent actuation of the slider <NUM> from the unlock position to a third position. Actuating the slider <NUM> from the unlock position to the third position can increase tension on the lock line <NUM> beyond the tension on the lock line <NUM> when the lock line handle <NUM> is in the unlock position. This third position can be useful during troubleshooting. The override mechanism can be a latch-detent lock, pin, push button, slide or the like.

Referring to <FIG>, for purpose of illustration and not limitation, slider <NUM> can be releasably coupled to the main body <NUM>. The lock line <NUM> can include a first portion fixedly coupled to the slider <NUM> and a second portion releasably coupled to the slider <NUM>. The lock line <NUM> can further have an intermediate portion that extends to and is releasably coupled to the harness <NUM> of fixation device <NUM> disposed proximate the distal end of the shaft <NUM>. Accordingly, to release the harness <NUM>, the second portion of lock line <NUM> can be released from the slider <NUM>, and the slider <NUM> can be released and pulled away from handle <NUM>, thereby withdrawing the lock line <NUM>. As shown in <FIG>, slider 2330A slides away from handle <NUM> to deploy. Slider 2330A can include release assembly 2340A to prevent unwanted release. Release assembly 2340A can include, for example, a slide 2342A and catch 2341A. As shown in <FIG>, slider 2330B rotates off handle <NUM> to deploy. Slider 2330B can include release assembly 2340B to prevent unwanted release. Release assembly 2340B can include, for example, a catch 2341B. As shown in <FIG>, slider 2330C is released by pinch button release assembly 2340C. Pinch button release assembly <NUM> can move catch 2341C and thereby release slider 2330C. The process of releasing the slider <NUM> (e.g., 2330A, 2330B, 2330C) can simultaneously release the second portion of the lock line <NUM>. The slider <NUM> (e.g., 2330A, 2330B, 2330C) can then be withdrawn, and can likewise withdraw lock line <NUM> because the first portion remains coupled to the slider <NUM> (e.g., 2330A, 2330B, 2330C).

Although particular lock line handles are described herein, this disclosure contemplates any suitable lock line handle. For example, and with reference to <FIG> for purpose of illustration and not limitation, handle <NUM> can have any of the features described herein above related to handles. For example, handle <NUM> can include the lock line handle <NUM>. Lock line handle <NUM> can have a T-shape, or similar shape for ergonomic grasping. Although shown as a T-shape, any ergonomic shape which can allow a user to easily apply a significant amount of proximal force on handle <NUM> is suitable. Lock line handle <NUM> can be in a distal position (<FIG>) to lock the fixation device <NUM>, and lock line handle <NUM> can slide relative handle <NUM>, for example, proximally, to lock the fixation device. With reference to <FIG> for purpose of illustration and not limitation, handle <NUM> can have any of the features described herein above related to handles. For example, lock line handle <NUM> can be configured to pivot relative the handle to actuate between the lock position and the unlock position. For example, lock line handle can be in a distal position (not shown) to lock the fixation device <NUM> and can rotated relative handle <NUM> to a proximal position to unlock the fixation device <NUM> (<FIG>). Referring to <FIG> for purpose of illustration and not limitation, handle <NUM> can have any of the features described herein above related to handles. Lock line handle <NUM> can have a pear shape, as described above. <FIG> show the lock line handle <NUM> in the lock position and unlock position, respectively. As noted above, the lock line handle can act as a flag in the unlock position to indicate to a user that the fixation device <NUM> is unlocked. <FIG> show the lock line handle in the unlock position and the third position, respectively.

Although particular release assemblies for the lock line handle are described herein, this disclosure contemplates any suitable release assembly for the lock line handle. For example, and with refence to <FIG>, the release assembly can be a push-button release. <FIG> shows the lock line handle <NUM> with the push button 6310A pressed and the lock line handle <NUM> ready for removal from the handle <NUM>. <FIG> shows the lock line handle <NUM> removed from the handle <NUM>. <FIG> shows a cut-away view of the push-button release 6310A in the locked position (i.e., preventing release of the lock line handle <NUM>). <FIG> shows a cut-away view of the push-button release 6310A in the unlock position (i.e., allowing release of the lock line handle). As shown, when push bottom release 6310A is pressed downwardly (arrow 6310C), flaps 6310B can extend outwardly (arrows 6310D), and release lock line handle <NUM> from handle <NUM>.

Although described particularly above, in accordance with the disclosed subject matter, the lock line can be coupled to the lock line handle in any suitable manner. For example, and with reference to <FIG>, the lock line handle <NUM> can include a spool 6310E for receiving the lock line <NUM>. When the lock line handle is rotated, the lock line <NUM> can rotate around the spool 6310E. A first end portion of the lock line <NUM> can extend through a slot <NUM> and can be attached to the shaft <NUM>. A second end portion of the lock line can loop around spool 6310E, go through a hole 6310I in the spool 6310E, and can be trapped by the shaft <NUM>. This loop can ensure the line does not slip during tensioning. During deployment, the shaft <NUM> can be removed, as described above, which can free the second end portion of the lock line <NUM>. Continuing to pull the shaft <NUM> can pull the entire length of the lock line <NUM> out of the delivery system <NUM>. With reference to <FIG>, for purpose of illustration and not limitation, the first portion of the lock line can be fixedly coupled to the lock line handle <NUM> by a swivel head set screw 6310J.

Although particular lock assemblies for the lock line handle are described herein, this disclosure contemplates any suitable lock assembly. Referring to <FIG> for purpose of illustration and not limitation, an exemplary lock line handle <NUM> is provided. The lock line handle <NUM> can include a lock assembly, for example, including activation lever 7310A for actuating a latch-detent lock. The latch-detent lock can prevent movement of the lock line handle between the lock and unlock positions unless the activation lever is actuated. The lock assembly can also prevent (or allow) movement between the unlock position and the third position. For example, the latch-detent lock can include a pin 7310B and detent 7310C disposed in track 7310D. The pin 7310B can engage the beginning or end of track (see e.g., <FIG>) or detent 7310B (see e.g., <FIG>). The lever of the lock assembly can control a latch-detent lock. <FIG> shows the lock line handle in the locked position with a latch-detent lock engaged. <FIG> shows the lock line handle in the unlock position with a latch-detent lock engaged. <FIG> shows a latch-detent lock disengaged to permit movement of the lock line handle <NUM>. Although the lock assembly includes a lever 7310A, the lock assembly can include any suitable activation feature, such as a button or switch. The lock line handle <NUM> can also include a safety feature, for example a pin 7310E, to prevent premature actuation of the release assembly. <FIG> shows a pin 7310E that needs to be removed before the push-button release 7310F can be pressed to release the lock line handle <NUM>.

Referring to <FIG>, for purpose of illustration and not limitation, medical delivery system <NUM> including a steerable guide system <NUM> is provided. The steerable guide system <NUM> can include multiple steerable catheter components. For example, and not limitation, steerable guide system <NUM> can include an outer guide catheter <NUM>, having a proximal end <NUM> and a distal end <NUM>, and an inner guide catheter <NUM>, having a proximal end <NUM> and a distal end <NUM>, wherein the inner guide catheter <NUM> is positioned coaxially within the outer guide catheter <NUM>, as shown. In addition, a hemostatic valve <NUM> can be disposed within handle <NUM> or external to handle <NUM> as shown to provide leak-free sealing with or without the inner guide catheter <NUM> in place. The distal ends <NUM>, <NUM> of catheter <NUM>, <NUM>, respectively, are sized to be passable to a body cavity, typically through a body lumen such as a vascular lumen.

Manipulation of the guide catheter <NUM>, <NUM> can be achieved with the use of handles <NUM>, <NUM> attached to the proximal ends of the catheter <NUM>, <NUM>. As shown, handle <NUM> is attached to the proximal end <NUM> of outer guide catheter <NUM> and handle <NUM> is attached to the proximal end <NUM> of inner guide catheter <NUM>. Inner guide catheter <NUM> is inserted through handle <NUM> and is positioned coaxially within outer guide catheter <NUM>.

The delivery catheter <NUM> can be inserted though handle <NUM> and can be positioned coaxially within inner guide catheter <NUM> and outer guide catheter <NUM>. The delivery catheter <NUM> includes a shaft <NUM>, having a proximal end <NUM> and a distal end <NUM>, and a handle <NUM> attached to the proximal end <NUM>. A fixation device <NUM> can be removably coupled to the distal end <NUM> for deliver to a site within the patient.

The outer guide catheter <NUM> and/or the inner guide catheter <NUM> can be precurved and/or have steering mechanisms to position the distal ends <NUM>, <NUM> in desired directions. Precurvature or steering of the outer guide catheter <NUM> can direct the distal end <NUM> in a first direction to create a primary curve while precurvature and/or steering of the inner guide catheter <NUM> can direct distal end <NUM> in a second direction, different from the first, to create a secondary curve. Together, the primary and secondary curves can form a compound curve. Furthermore, advancement of the entire interventional system <NUM> or the inner guide catheter <NUM> (relative to the outer guide catheter <NUM>) can further direct the distal end <NUM> of the inner guide catheter <NUM> toward a desired position. Advancement of the delivery catheter <NUM> through the coaxial guide catheters <NUM>, <NUM> can guide the delivery catheter <NUM> through the compound curve toward a desired direction, usually in a direction which will position the fixation device <NUM> in a desired location in the body.

<FIG> is an enlarged view of the controls of a medical delivery system <NUM> in accordance with the disclosed subject matter. Handles <NUM>, <NUM> of the steerable guide system <NUM> are shown. Each handle <NUM>, <NUM> includes a set of steering knobs 1300a, 1300b, as shown. Manipulation of guide catheter <NUM> and <NUM> can be achieved with the use of the steering knobs 1300a, 1300b attached to the proximal ends of the catheters <NUM>, <NUM>. Further details of exemplary delivery systems are disclosed in the patents and published applications incorporated by reference herein. Alternative handles and/or controls likewise are contemplated in accordance with the disclosed subject matter.

While the embodiments disclosed herein utilize a push-to-open, pull-to-close mechanism for opening and closing arms it should be understood that other suitable mechanisms can be used, such as a pull-to-open, push-to-close mechanism. A closure bias can be included, for example using a compliant mechanism such as a linear spring, helical spring, or leaf spring. Other actuation elements can be used for deployment of the gripper elements.

While the disclosed subject matter is described herein in terms of certain preferred embodiments for purpose of illustration and not limitation, those skilled in the art will recognize that various modifications and improvements can be made to the disclosed subject matter without departing from the scope thereof. Moreover, although individual features of one embodiment of the disclosed subject matter can be discussed herein or shown in the drawings of one embodiment and not in other embodiments, it should be readily apparent that individual features of one embodiment can be combined with one or more features of another embodiment or features from a plurality of embodiments.

In addition to the specific embodiments claimed below, the disclosed subject matter is also directed to other embodiments having any other possible combination of the dependent features claimed below and those disclosed above. As such, the particular features presented in the dependent claims and disclosed above can be combined with each other in other possible combinations. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosed subject matter to those embodiments disclosed.

Claim 1:
A medical device delivery system for delivering a medical implant, comprising:
a catheter (<NUM>) having a proximal end portion (<NUM>) and a distal end portion (<NUM>);
a handle (<NUM>) coupled to the proximal end portion (<NUM>) of the catheter (<NUM>);
a lock line handle (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) releasably coupled to the handle (<NUM>);
a release assembly configured to releasably couple the lock line handle (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) to the handle (<NUM>); and
a lock line (<NUM>) having a first end portion (92A) fixedly coupled to the lock line handle (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>), a second end portion (92B) releasably coupled to the lock line handle (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>);
wherein the second end portion (92B) is configured to be released from the lock line handle (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) by release of the lock line handle (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) from the handle (<NUM>) via operation of the release assembly.