Patent Description:
The present disclosure relates generally to implantable medical device delivery, and more specifically to methods, systems, and apparatuses for delivery of implantable medical devices such as shunts and heart valves.

Previously deployment methods for implantable medical devices such as interatrial shunt devices have difficulty properly positioning the devices. In addition, many of these systems do not have the ability to recapture or reposition a deployed device in instances where the deployment is not desirable. Therefore, a need exists for device delivery systems robust enough to deliver, reposition, recapture if needed and release the device when properly deployed.

<CIT> is directed to a prosthetic valve and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.

<CIT> is directed to a prosthetic heart valve and a heart valve delivery apparatus for delivery of the prosthetic heart valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic valve through the aorta for replacing a diseased native aortic valve. In one embodiment, a self-expanding valve comprises an expandable stent that is shaped to maintain the valve in the aortic annulus against axial without anchors or retaining devices that engage the surrounding tissue. A delivery apparatus for delivering s self-expanding prosthetic valve can be configured to allow controlled and precise deployment of the valve from a valve sheath so as to minimize or prevent jumping of the valve from the valve sheath.

<CIT> is directed to an apparatus for transcatheter detachment of a stent from a delivery device. A braided suture with an opening is inserted through a restraining hole in a glide (the opening is secured on one side by a knot or a series of knots ) and a release line is inserted through the braided suture opening. The braided suture is thus prevented from pulling through the restraining hole while the release line is through the opening. The braided suture is free to pass through the restraining hole after the release line is pulled out of the opening and thereafter pulled free of stent holes formed through a stent, thereby detaching the stent at a desired location.

<CIT> is directed to an axial pull wire tension mechanism for a self expanding stent including a delivery system composed of an inner tube, a middle tube and a lock wire, open wire knees and/or close wire eyelets at the both ends of the stent, and pull wires for tensioning the stent. The pull wires include at least one distal pull wire and at least one proximal pull wire. A pull wire ring is provided at the distal end of each of the pull wires. Each pull wire passes through an opening of the inner tubing head or the inner tube or the middle tube after the pull wire ring at its distal end is threaded through and locked temporarily by the lock wire, and travels between the open wire knees or the close wire eyelets at one end of the stent to constitute a temporary stent connection, thus forming the pull wire tension mechanism that can axially tension the stent. The present invention can locate the self-expanding stent in terms of its axial and rotational positions with great precision when in collaboration with the delivery system and the radially compression mechanism during the process of delivering the self-expanding stent into the patient's body, and is capable of either further adjustment should the position prove to be less ideal, or recycling should the stent prove to be incongruous after the expansion of the stent.

<CIT> discloses devices and methods to enhance the implantation, retreivability, or repositionability of a shunt device. Embodiments of shunt devices include pivotable sections providing the ability to maintain the device's engagement with a delivery system during implantation where the delivery system approaches an opening of the septum at an angle. Embodiments of devices also include configurations that allow for improved retrieval into a delivery system in the event that a malfunction or a problem with the patients physiology is detected.

In accordance with claim <NUM>, the implantable medical device is an implantable shunt device and a deployment system for an implantable shunt device includes an implantable shunt device, a catheter, a tip, one or more containing lines and one or more release lines. The implantable shunt device has a first side and a second side, each of the first and second sides including a stent element and a membrane component, each of the first and second sides including series of radially extending lobes and wherein the shunt device further includes a plurality of eyelets arranged on end portions of the lobes. The catheter has a proximal end and a distal end. The tip is arranged at the distal end of the catheter. The one or more constraining lines are arranged through the plurality of eyelets of the implantable shunt device, and are configured to collapse portions of the implantable shunt device toward the catheter. The one or more release lines are configured to engage the one or more constraining lines and maintain contact between the implantable medical device and the one or more constraining lines during deployment. The one or more release lines are partially nested in the tip.

The one or more constraining lines may be configured to engage eyelets on at least a first side of the implantable medical device.

The system may also include a sheath arranged about the catheter and configured to capture the collapsed implantable medical device.

The sheath may be configured to constrain the implantable medical device.

The one or more release lines may be configured to withdraw to release the one or more constraining lines.

The one or more constraining lines may include a constraining loop at a distal end of the one or more constraining lines, and the one or more release lines may be arranged through the constraining loop of the one or more constraining lines maintain contact between the implantable medical device and the one or more constraining lines during deployment.

The one or more constraining lines may be one or more constraining wires.

The system may also include a stop arranged on the catheter configured to limit movement of the implantable medical device in a direction opposite that of a direction tension is applied to the one or more constraining lines.

The system may also include one or more stops arranged distal to a distal end of the one or more constraining lines and configured to prevent the distal end of the one or more constraining lines from withdrawing from the one or more eyelets of the implantable medical device prior to removal of the one or more release lines.

The one or more release lines may be configured to facilitate deployment and act as a ramp to guide the implantable medical device from a sheath.

In examples not claimed, the implantable medical device may be a heart valve, or a valved conduit.

A deployment system may include a sheath arranged configured to hold the implantable medical device in a collapsed configuration; one or more constraining lines arranged through a portion of the implantable medical device and configured to collapse portions of the implantable medical device toward the catheter in response to tension applied to the one or more constraining lines and allow expansion of the implantable medical device in response to release of the tension; and one or more release lines configured to engage the one or more constraining lines and maintain contact between the implantable medical device and the one or more constraining lines during deployment and withdraw to release the one or more constraining lines to deploy the implantable medical device to a deployed configuration.

The eyelets of the medical device may be arranged about a circumference of the implantable medical device and the one or more constraining lines may be arranged through the eyelets.

Each of the one or more constraining lines may include a constraining loop at a distal end of the one or more constraining lines, and the one or more release lines may be arranged through the constraining loop of the one or more constraining lines maintain contact between the implantable medical device and the one or more constraining lines during deployment.

At least one of the one or more constraining lines and the one or more release lines may be coupled to the catheter near a distal end thereof.

The catheter includes a tip coupled to the distal end of the catheter, and at least one of the one or more constraining lines and the one or more release lines partially nested in the tip.

A method of deploying an implantable medical device not according to the invention may include arranging a catheter at a target location with the implantable medical device arranged within a collapsed configuration within a sheath; allowing expansion of at least a portion of the implantable medical device by releasing tension on one or more constraining lines arranged through one or more eyelets of the implantable medical device; and releasing the one or more constraining lines from the implantable medical device by removing one or more release lines engage with the one or more constraining lines.

The method may also include comprising advancing the sheath to deploy a first side of the implantable medical device and wherein allowing expansion of the portion of the implantable medical device includes allowing expansion of a second side of the implantable medical device by releasing tension on the one or more constraining lines.

The method may also include reconstraining the implantable medical device by applying tension to the one or more constraining lines and retracting the implantable medical device within the delivery sheath.

The method may also include deploying the second side of the implantable medical device by releasing tension applied to the constraining lines.

The foregoing Examples are just that, and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive in nature.

This disclosure is not meant to be read in a restrictive manner. For example, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology.

With respect to terminology of inexactitude, the terms "about" and "approximately" may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error, differences in measurement and/or manufacturing equipment calibration, human error in reading and/or setting measurements, minor adjustments made to optimize performance and/or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and/or manipulation of objects by a person or machine, and/or the like, for example. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms "about" and "approximately" can be understood to mean plus or minus <NUM>% of the stated value.

Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.

<FIG> illustrates an example implantable medical device <NUM> in accordance with an embodiment. The implantable medical device <NUM> is shown implanted within a heart H of a patient. The device <NUM> is shown arranged between the patient's left atrium LA and right atrium RA. In some instances, the device <NUM> may be used within the heart H, for example, between the left and right atriums LA, RA. As shown, the device <NUM> generally includes a first frame component <NUM> arranged on a first side of a septum (e.g., within the right atrium RA), a second frame component <NUM> arranged on a second side of the septum (e.g., within the left atrium LA), and a conduit <NUM> extending through the septum. A needle may be used to create an opening in the septum. The implantable medical device <NUM> may be a shunt device with the conduit <NUM> being a fluid flow lumen between the sides of the implantable medical device <NUM>.

<FIG> is an example delivery system <NUM> and implantable medical device <NUM> such as a shunt device in accordance with an embodiment. The implantable medical device <NUM> includes a first side <NUM> and a second side <NUM>. Each of the sides <NUM>, <NUM> includes a stent element <NUM> and a membrane component <NUM> as shown in <FIG>. The sides <NUM>, <NUM> are configured to conform to the patient's anatomy (i.e., the first side of the septum, for example). The first side <NUM> and the second side <NUM> may be separate and distinct components with a flexible interconnection that connects the two sides in a manner that decouples forces acting on the first side <NUM> from forces acting on the second side <NUM>. For example, the first side <NUM> and the second side <NUM> may be free to move, in response to movement of the patient's anatomy, separately from one another. In this manner, forces acting on one of the first side <NUM> and the second side <NUM> are maintained within the other of the first side <NUM> and the second side <NUM>. The forces acting on one of the first side <NUM> and the second side <NUM> may be isolated to the frame component to which the force is acted on.

The delivery system <NUM> includes a catheter <NUM> configured to delivery through a patient's vascular to a delivery site. The delivery system <NUM> includes a tip <NUM>, that may be atraumatic and may be radiopaque, arranged at a distal end of the catheter <NUM>. The delivery system <NUM> also includes one or more constraining lines <NUM> arranged through a portion of the implantable medical device <NUM>. The one or more constraining lines <NUM> are configured to collapse portions of the implantable medical device <NUM> toward the catheter <NUM>. The implantable medical device <NUM> includes a series of lobes or radially extending loops <NUM>. The lobes or radially extending loops <NUM> are formed by portions of the stent element <NUM> and the membrane component <NUM> and may be on each of the first side <NUM> and the second side <NUM>. In certain instances, the one or more constraining lines <NUM> are configured to collapse the lobes or radially extending loops <NUM> of one or both of the sides <NUM>, <NUM> toward the catheter <NUM>.

The delivery system <NUM> also includes one or more release lines <NUM> are configured to engage the one or more constraining lines <NUM> and to maintain contact between the implantable medical device <NUM> and the one or more constraining lines <NUM> during deployment. The release lines <NUM> partially embed or nest within the tip <NUM>.

Examples of materials for the constraining lines <NUM> or release lines <NUM> may be metals such as stainless steels, cobalt-chromium alloys and nitinol. The release lines can also be formed from high strength polymer fibers such as ultra-high molecular weight polyethylene fibers or aramid fibers. However, any material capable of providing sufficient tension is within the scope of the present disclosure. The constraining lines <NUM> or release lines <NUM> may also be formed from a film such as kapton, a polymer (e.g., Polyether ether ketone (Peek)), laser cut of a hypotube, or a cut polymer tube).

<FIG> illustrates features of delivery system <NUM> and implantable medical device <NUM> employed in accordance with an embodiment. As shown in <FIG>, the implantable medical device <NUM> is in a partially collapsed or constrained configuration with the second side <NUM> (e.g., a proximal side) being collapsed or constrained. In addition, the first side <NUM> and the second side <NUM> includes eyelets <NUM>.

In accordance with claim <NUM>, the eyelets <NUM> are arranged on end portions of the lobes or radially extending loops <NUM>. In certain instances, each of the lobes or radially extending loops <NUM> include an eyelet <NUM>, and in other instances, selected ones or pairs of the lobes or radially extending loops <NUM> include eyelets <NUM>. In addition, the lobes or radially extending loops <NUM> of the second side <NUM> may include eyelets <NUM> with the lobes or radially extending loops <NUM> of the first side <NUM> not including eyelets. In other instances, the lobes or radially extending loops <NUM> of the first side <NUM> may include eyelets <NUM> with the lobes or radially extending loops <NUM> of the second side <NUM> not including eyelets. Further and as shown, the lobes or radially extending loops <NUM> of both sides <NUM>, <NUM> include the eyelets <NUM>.

In certain instances and as shown in further detail in <FIG>, the one or more constraining lines <NUM> are configured to engage the eyelets <NUM>. The constraining lines <NUM> may be arranged through the eyelets <NUM>. In addition, the constraining lines <NUM> may engage (and be arrange through) only the eyelets <NUM> on the second (proximal) side <NUM> of the implantable medical device <NUM>. In other instances, the constraining lines <NUM> may engage (and be arrange through) only the eyelets <NUM> on the first (distal) side <NUM> of the implantable medical device <NUM>. Further, the constraining lines <NUM> may engage (and be arrange through) the eyelets <NUM> on both the first (distal) side <NUM> and the second (proximal) side <NUM> of the implantable medical device <NUM>. In instances where the implantable medical device <NUM> does not include eyelets <NUM>, the constraining lines <NUM> and release lines <NUM> may be arranged through membrane component <NUM>.

To release or deploy the implantable medical device <NUM>, the one or more release lines <NUM> are withdrawn to release the one or more constraining lines <NUM>. In certain instances and as shown in particular with reference to <FIG>, the one or more constraining lines <NUM> include a constraining loop <NUM> at a distal end of the one or more constraining lines <NUM>. The one or more release lines <NUM> may be arranged through the constraining loop <NUM> of the one or more constraining lines <NUM> and maintain contact between the implantable medical device <NUM> and the one or more constraining lines <NUM> during deployment. The one or more release lines <NUM> are withdrawn through the constraining loop <NUM> to release the one or more constraining lines <NUM>. In certain instances, the implantable medical device <NUM> includes only membrane material between the first side <NUM> and the second side <NUM>. As shown, the release lines <NUM> are configured to facilitate deployment and act as a ramp to guide the implantable medical device <NUM> from a sheath. The release lines <NUM> are configured to pull down the first side <NUM> of the implantable medical device <NUM> radially.

Tension applied to the constraining lines <NUM> to collapse portions of the implantable medical device <NUM> toward the catheter <NUM>. More specifically, the lobes or radially extending loops <NUM> (radially projecting) of one or both sides <NUM>, <NUM> are collapsed. Tension on an end of the constraining lines <NUM> not arranged with the implantable medical device <NUM> retracts the constraining lines <NUM> into the catheter <NUM>. In certain instances, the sheath <NUM> may also be used to facilitate delivery and constrain the implantable medical device <NUM>. After the lobes or radially extending loops <NUM> of one or both sides <NUM>, <NUM> are collapsed, the sheath <NUM> may be advanced to further constrain the lobes or radially extending loops <NUM> of one or both sides <NUM>, <NUM>. In certain instances, the lobes or radially extending loops <NUM> of the second side <NUM> are collapsed, and the sheath <NUM> is advanced to constrain the lobes or radially extending loops <NUM> of the first side <NUM>. The sheath <NUM> may be advanced to the tip <NUM>. As the he constraining lines <NUM> are retracted into the catheter <NUM>, the implantable medical device <NUM> may be collapsed within the sheath <NUM>.

In one example of a deployment sequence, to deploy the implantable medical device <NUM>, the above note constraining sequence is reversed. Once the tip <NUM> and catheter <NUM> is across the septum the sheath <NUM> is retracted and the lobes or radially extending loops <NUM> of the first side <NUM> are deployed. The sheath <NUM> may be pulled back so that the lobes or radially extending loops <NUM> of the first side <NUM> apply tension to the septum. Prior to release of the constraining lines <NUM> and the release lines <NUM>, the positioning of the implantable medical device <NUM> can be evaluated. If the positioning is not satisfactory or desirable, the implantable medical device <NUM> may be reconstrained and repositioned. To reconstrain and reposition the implantable medical device <NUM>, the constraining sequence described above may be followed (e.g., tension may be applied to the one or more constraining lines <NUM> and the implantable medical device <NUM> may be retracted within the sheath <NUM>). The second side <NUM> of the implantable medical device <NUM> may be deployed by releasing tension applied to the constraining lines <NUM>.

After the implantable medical device <NUM> is positioned, the constraining lines <NUM> and the release lines <NUM> are released so that the lobes or radially extending loops <NUM> of the second side <NUM> are deployed. The release lines <NUM> are then retracted back to release the constraining loop <NUM> of the one or more constraining lines <NUM> from the eyelets <NUM>. The one or more constraining lines <NUM> and the release lines <NUM> are coupled to separate pull mechanisms to apply tension to the constraining lines <NUM> and the release lines <NUM>. This may facilitate simultaneous manipulation of the constraining lines <NUM> and simultaneous manipulation of the release lines <NUM>. The constraining lines <NUM> and the release lines <NUM> can be released simultaneously or individually depending on the deployment to maintain stability of the implantable medical device <NUM> during deployment.

In certain instances, the constraining lines <NUM> are constraining wires (e.g., formed of a metal or metal-type material). In this manner, the constraining lines <NUM> may have sufficient strength and flexibility to constrain the implantable medical device <NUM>. Using the system <NUM> as described herein may be beneficial, as compared to a more rigid system, as the deployment system <NUM> is configured to allow the catheter <NUM> to be at a smaller acute angle to the septum.

<FIG> is a delivery system <NUM> including an optional stop <NUM> and implantable medical device <NUM> in a first configuration in accordance with an embodiment. During deployment and pull back of the sheath <NUM>, the stop <NUM> pushes the device out of the sheath <NUM> as the sheath is retracted.

In certain instances, the constraining lines <NUM> may be fixed to catheter <NUM>. To constrain the implantable medical device <NUM>, in these instances, the catheter <NUM> is pulled back relative to the outer sheath <NUM>. The sheath <NUM> pulls the lobes or radially extending loops <NUM> of one or both sides <NUM>, <NUM> onto itself as shown in <FIG>. The stop <NUM> is configured to limit movement of the implantable medical device <NUM> in a direction opposite that of a direction tension is applied to the one or more constraining lines <NUM> or in a direction opposite that of the sheath <NUM> movement.

<FIG> is a delivery system <NUM> including an example stop <NUM> and implantable medical device <NUM> in accordance with an embodiment. The stop <NUM> is shown arranged at a distal end of a constraining line <NUM>. In certain instances, each of the one or more constraining lines <NUM> may include the stop <NUM>. The stop <NUM> is configured to prevent the distal end of the one or more constraining lines <NUM> from withdrawing from the one or more eyelets <NUM> of the implantable medical device <NUM> prior to removal of the one or more release lines <NUM>.

To release or deploy the implantable medical device <NUM>, the one or more release lines <NUM> are withdrawn to release the one or more constraining lines <NUM>. As shown in <FIG>, the one or more release lines <NUM> may be arranged through the constraining loop <NUM> of the one or more constraining lines <NUM> and maintain contact between the implantable medical device <NUM> and the one or more constraining lines <NUM> during deployment. The one or more release lines <NUM> are withdrawn to through the constraining loop <NUM> to facilitate release the one or more constraining lines <NUM>.

<FIG> show a delivery system <NUM> in various stages of deploying an implantable medical device <NUM> in accordance with an embodiment. As shown in <FIG>, the implantable medical device <NUM> is shown in a delivery or fully collapsed configuration. As shown, the implantable medical device <NUM> is arranged within a sheath <NUM>.

The implantable medical device <NUM> is shown in a partially deployed configuration in <FIG>. The implantable medical device <NUM> may include a first side <NUM> and a second side <NUM>. The sides <NUM>, <NUM> are configured to conform to the patient's anatomy (i.e., the first side of the septum, for example). The first side <NUM> and the second side <NUM> may be separate and distinct components with a flexible interconnection that connects the two sides in a manner that decouples forces acting on the first side <NUM> from forces acting on the second side <NUM>. As shown in <FIG>, the first side <NUM> is partially deployed. The sheath <NUM> has been withdrawn to unconstrain the first side <NUM> of the implantable medical device <NUM>.

The sheath <NUM> may be further withdrawn to fully deploy the first side <NUM> of the implantable medical device <NUM> as shown in <FIG>. The delivery system <NUM> also includes one or more constraining lines <NUM> arranged through a portion of the implantable medical device <NUM>. The one or more constraining lines <NUM> are configured to collapse portions of the implantable medical device <NUM> (e.g., after the sheath <NUM> is withdrawn).

As noted above, the delivery system <NUM> also includes one or more release lines <NUM> configured to engage the one or more constraining lines <NUM> and maintain contact between the implantable medical device <NUM> and the one or more constraining lines <NUM> during deployment. The constraining lines <NUM> and the release lines <NUM> may facilitate controlled deployment of the second side <NUM> of the implantable medical device <NUM>. As shown in <FIG>, the constraining lines <NUM> and the release lines <NUM> may be configured to partially constrain the second side <NUM> of the implantable medical device <NUM>. The constraining lines <NUM> and the release lines <NUM> may be configured to facilitate act as a ramp to guide the implantable medical device <NUM> from the sheath <NUM>.

<FIG> is another example delivery system <NUM> and implantable medical device <NUM> in accordance with an embodiment. The implantable medical device <NUM> as deployed with the delivery system <NUM> shown in <FIG> may be a replacement heart valve, shunt, stent, stent-graft, or other similar medical device. As shown in <FIG>, the implantable medical device <NUM> is a replacement heart valve. As shown, the implantable medical device <NUM> is implanted across a native valve <NUM>.

The delivery system <NUM> includes a catheter <NUM> configured to delivery through a patient's vascular to a delivery site. The delivery system <NUM> includes a tip <NUM>, that may be atraumatic and may be radiopaque, arranged at a distal end of the catheter <NUM>. The delivery system <NUM> also includes one or more constraining lines <NUM> arranged through a portion of the implantable medical device <NUM>.

As shown in <FIG>, the implantable medical device <NUM> includes eyelets <NUM> arranged about a circumference of the implantable medical device <NUM>. In certain instances, the implantable medical device <NUM> includes eyelets <NUM> arranged at a proximal end of the implantable medical device <NUM>. As shown in further detail with reference to <FIG>, the one or more constraining lines <NUM> may be arranged through the eyelets <NUM>. The one or more constraining lines <NUM> are configured to collapse portions of the implantable medical device <NUM> toward the catheter <NUM>. Applying tension to an end (not shown) of the constraining lines <NUM> collapses the implantable medical device <NUM> toward the catheter <NUM> for implantation. As discussed in detail above, the delivery system <NUM> may include a sheath (not shown) configured to hold the implantable medical device <NUM> in a collapsed configuration. The constraining lines <NUM> enable recapture of the implantable medical device <NUM> after initial deployment. Recapture of the implantable medical device <NUM> using the constraining lines <NUM> allows for repositioning of the implantable medical device <NUM>.

The delivery system <NUM> also includes one or more release lines <NUM> configured to engage the one or more constraining lines <NUM> and maintain contact between the implantable medical device <NUM> and the one or more constraining lines <NUM> during deployment. To release or deploy the implantable medical device <NUM>, the one or more release lines <NUM> are withdrawn to release the one or more constraining lines <NUM> as discussed in further detail above. The one or more release lines <NUM> are arranged through or coupled to the one or more constraining lines <NUM> and maintain contact between the implantable medical device <NUM> and the one or more constraining lines <NUM> during deployment. The one or more release lines <NUM> are withdrawn to release the one or more constraining lines <NUM>.

Tension applied to the constraining lines <NUM> to collapse portions of the implantable medical device <NUM> toward the catheter <NUM>. Tension on an end of the constraining lines <NUM> not arranged with the implantable medical device <NUM> retracts the constraining lines <NUM> into the catheter <NUM>. In certain instances, the sheath (not shown) may also be used to facilitate delivery and constrain the implantable medical device <NUM>. As the constraining lines <NUM> are retracted into the catheter <NUM>, the implantable medical device <NUM> may be collapsed into the sheath or catheter <NUM>.

In one example of a deployment sequence, to deploy the implantable medical device <NUM>, the catheter <NUM> is positioned across the native valve <NUM>, the catheter <NUM> or a sheath may be retracted to expose a distal portion of the device <NUM>. The catheter <NUM> may further be retracted to expose the proximal end of the device <NUM>. Prior to release of the constraining lines <NUM> and the release lines <NUM>, the positioning of the implantable medical device <NUM> can be evaluated. If the positioning is not satisfactory or desirable, the implantable medical device <NUM> may be reconstrained and repositioned. To reconstrain and reposition the implantable medical device <NUM>, the constraining sequence described above may be followed (e.g., tension may be applied to the one or more constraining lines <NUM> and the implantable medical device <NUM> may be retracted within the sheath or catheter <NUM>). After the implantable medical device <NUM> is positioned, the constraining lines <NUM> and the release lines <NUM> are released.

In certain instances, the delivery system <NUM> may include a secondary constraining element <NUM> (e.g., a hoop, ring, or constraining loops as shown) that may be arranged about the implantable medical device <NUM>. The secondary constraining element <NUM> may be configured to collapse and expand a distal portion of the implantable medical device <NUM>.

As shown in <FIG>, the implantable medical device <NUM> includes eyelets <NUM> arranged about a circumference of the implantable medical device <NUM>. The eyelets <NUM> are arranged about a skirt portion <NUM> of the implantable medical device <NUM> that extends from the valve frame structure of the heart valve. In addition and as shown, the constraining liens <NUM> may be individually arranged through the eyelets <NUM> and also circumferentially through the eyelets <NUM> as shown in <FIG>.

The delivery system <NUM> also includes one or more release lines <NUM> are configured to engage the one or more constraining lines <NUM> and maintain contact between the implantable medical device <NUM> and the one or more constraining lines <NUM> during deployment. To release or deploy the implantable medical device <NUM>, the one or more release lines <NUM> are withdrawn to release the one or more constraining lines <NUM> as discussed in further detail above. The one or more release lines <NUM> are arranged through or coupled to the one or more constraining lines <NUM> and maintain contact between the implantable medical device <NUM> and the one or more constraining lines <NUM> during deployment. The one or more release lines <NUM> are withdrawn to release the one or more constraining lines <NUM>.

Claim 1:
A deployment system (<NUM>) for an implantable shunt device (<NUM>), the system comprising:
an implantable shunt device (<NUM>) having a first side (<NUM>) and a second side (<NUM>), each of the first and second sides including a stent element (<NUM>) and a membrane component (<NUM>), each of the first and second sides including series of radially extending lobes (<NUM>) formed by portions of the stent element (<NUM>) and the membrane component (<NUM>) and wherein the shunt device further includes a plurality of eyelets (<NUM>) arranged on end portions of the lobes;
a catheter (<NUM>) having a proximal end and a distal end;
a tip (<NUM>) arranged at the distal end of the catheter;
one or more constraining lines (<NUM>) arranged through the plurality of eyelets (<NUM>) of the implantable shunt device (<NUM>), the one or more constraining lines (<NUM>) being configured to collapse portions of the implantable shunt device (<NUM>) toward the catheter (<NUM>); and
one or more release lines (<NUM>) configured to engage the one or more constraining lines (<NUM>) and maintain contact between the implantable shunt device (<NUM>) and the one or more constraining lines (<NUM>) during deployment, the one or more release lines (<NUM>) being partially nested in the tip (<NUM>).