System for delivering an implantable medical device

Description

PRIORITY CLAIM

[0001] This application claims the benefit of Provisional Application No. 62 / 699,794, filed July 18, 2018.FIELD

[0002] 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.BACKGROUND

[0003] 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.

[0004] US 2014 / 343670 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.

[0005] US 2010 / 049313 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.

[0006] WO 2015 / 109027 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.

[0007] US 2009 / 099640 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.

[0008] US2014 / 012368 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.SUMMARY

[0009] The invention is defined by the appended claims.

[0010] In accordance with claim 1, 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.

[0011] The one or more constraining lines may be configured to engage eyelets on at least a first side of the implantable medical device.

[0012] The system may also include a sheath arranged about the catheter and configured to capture the collapsed implantable medical device.

[0013] The sheath may be configured to constrain the implantable medical device.

[0014] The one or more release lines may be configured to withdraw to release the one or more constraining lines.

[0015] 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.

[0016] The one or more constraining lines may be one or more constraining wires.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] In examples not claimed, the implantable medical device may be a heart valve, or a valved conduit.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] The method may also include deploying the second side of the implantable medical device by releasing tension applied to the constraining lines.

[0030] 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.BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure. FIG. 1 is an example implantable medical device in accordance with an embodiment. FIG. 2 is an example delivery system and shunt device in accordance with an embodiment. FIG. 3A is an example delivery system and shunt device in accordance with an embodiment. FIG. 3B is first close-up view of the delivery system and shunt device, shown in FIG. 3A, in accordance with an embodiment. FIG. 3C is second close-up view of the delivery system and shunt device, shown in FIGS. 3A-3B, in accordance with an embodiment. FIG. 4A is an example delivery system including a stop and shunt device in a first configuration in accordance with an embodiment. FIG. 4B is the delivery system and shunt device, shown in FIG. 4A, in a second configuration in accordance with an embodiment. FIG. 5 is another example delivery system including a stop and shunt device in accordance with an embodiment. FIGS. 6A-6C show a delivery system in various stages of deploying a shunt device in accordance with an embodiment. FIG. 7A is another example delivery system and implantable medical device in accordance with an embodiment. FIG. 7B is a close-up view of a portion of the delivery system shown in FIG. 9A. FIG. 8A is another example delivery system and implantable medical device in accordance with an embodiment. FIG. 8B is a close-up view of a portion of the delivery system shown in FIG. 8A. DETAILED DESCRIPTIONDefinitions and Terminology

[0032] 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.

[0033] 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 10% of the stated value.Description of Various Embodiments

[0034] 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.

[0035] FIG. 1 illustrates an example implantable medical device 100 in accordance with an embodiment. The implantable medical device 100 is shown implanted within a heart H of a patient. The device 100 is shown arranged between the patient's left atrium LA and right atrium RA. In some instances, the device 100 may be used within the heart H, for example, between the left and right atriums LA, RA. As shown, the device 100 generally includes a first frame component 110 arranged on a first side of a septum (e.g., within the right atrium RA), a second frame component 120 arranged on a second side of the septum (e.g., within the left atrium LA), and a conduit 130 extending through the septum. A needle may be used to create an opening in the septum. The implantable medical device 100 may be a shunt device with the conduit 130 being a fluid flow lumen between the sides of the implantable medical device 100.

[0036] FIG. 2 is an example delivery system 200 and implantable medical device 202 such as a shunt device in accordance with an embodiment. The implantable medical device 202 includes a first side 204 and a second side 206. Each of the sides 204, 206 includes a stent element 222 and a membrane component 224 as shown in FIG. 2. The sides 204, 206 are configured to conform to the patient's anatomy (i.e., the first side of the septum, for example). The first side 204 and the second side 206 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 204 from forces acting on the second side 206. For example, the first side 204 and the second side 206 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 204 and the second side 206 are maintained within the other of the first side 204 and the second side 206. The forces acting on one of the first side 204 and the second side 206 may be isolated to the frame component to which the force is acted on.

[0037] The delivery system 200 includes a catheter 208 configured to delivery through a patient's vascular to a delivery site. The delivery system 200 includes a tip 210, that may be atraumatic and may be radiopaque, arranged at a distal end of the catheter 208. The delivery system 200 also includes one or more constraining lines 212 arranged through a portion of the implantable medical device 202. The one or more constraining lines 212 are configured to collapse portions of the implantable medical device 202 toward the catheter 208. The implantable medical device 202 includes a series of lobes or radially extending loops 214. The lobes or radially extending loops 214 are formed by portions of the stent element 222 and the membrane component 224 and may be on each of the first side 204 and the second side 206. In certain instances, the one or more constraining lines 212 are configured to collapse the lobes or radially extending loops 214 of one or both of the sides 204, 206 toward the catheter 208.

[0038] The delivery system 200 also includes one or more release lines 216 are configured to engage the one or more constraining lines 212 and to maintain contact between the implantable medical device 202 and the one or more constraining lines 212 during deployment. The release lines 216 partially embed or nest within the tip 210.

[0039] Examples of materials for the constraining lines 212 or release lines 216 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 212 or release lines 216 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).

[0040] FIG. 3A illustrates features of delivery system 200 and implantable medical device 202 employed in accordance with an embodiment. As shown in FIG. 3A, the implantable medical device 202 is in a partially collapsed or constrained configuration with the second side 206 (e.g., a proximal side) being collapsed or constrained. In addition, the first side 204 and the second side 208 includes eyelets 318.

[0041] In accordance with claim 1, the eyelets 318 are arranged on end portions of the lobes or radially extending loops 214. In certain instances, each of the lobes or radially extending loops 214 include an eyelet 318, and in other instances, selected ones or pairs of the lobes or radially extending loops 214 include eyelets 318. In addition, the lobes or radially extending loops 214 of the second side 206 may include eyelets 318 with the lobes or radially extending loops 214 of the first side 204 not including eyelets. In other instances, the lobes or radially extending loops 214 of the first side 204 may include eyelets 318 with the lobes or radially extending loops 214 of the second side 206 not including eyelets. Further and as shown, the lobes or radially extending loops 214 of both sides 204, 206 include the eyelets 318.

[0042] In certain instances and as shown in further detail in FIGS. 3B-C, the one or more constraining lines 212 are configured to engage the eyelets 318. The constraining lines 212 may be arranged through the eyelets 318. In addition, the constraining lines 212 may engage (and be arrange through) only the eyelets 318 on the second (proximal) side 206 of the implantable medical device 202. In other instances, the constraining lines 212 may engage (and be arrange through) only the eyelets 318 on the first (distal) side 204 of the implantable medical device 202. Further, the constraining lines 212 may engage (and be arrange through) the eyelets 318 on both the first (distal) side 204 and the second (proximal) side 206 of the implantable medical device 202. In instances where the implantable medical device 202 does not include eyelets 318, the constraining lines 212 and release lines 216 may be arranged through membrane component 224.

[0043] To release or deploy the implantable medical device 202, the one or more release lines 216 are withdrawn to release the one or more constraining lines 212. In certain instances and as shown in particular with reference to FIG. 3, the one or more constraining lines 212 include a constraining loop 320 at a distal end of the one or more constraining lines 212. The one or more release lines 216 may be arranged through the constraining loop 320 of the one or more constraining lines 212 and maintain contact between the implantable medical device 202 and the one or more constraining lines 212 during deployment. The one or more release lines 216 are withdrawn through the constraining loop 320 to release the one or more constraining lines 212. In certain instances, the implantable medical device 202 includes only membrane material between the first side 202 and the second side 204. As shown, the release lines 216 are configured to facilitate deployment and act as a ramp to guide the implantable medical device 202 from a sheath. The release lines 216 are configured to pull down the first side 204 of the implantable medical device 202 radially.

[0044] Tension applied to the constraining lines 212 to collapse portions of the implantable medical device 202 toward the catheter 208. More specifically, the lobes or radially extending loops 214 (radially projecting) of one or both sides 204, 206 are collapsed. Tension on an end of the constraining lines 212 not arranged with the implantable medical device 202 retracts the constraining lines 212 into the catheter 208. In certain instances, the sheath 322 may also be used to facilitate delivery and constrain the implantable medical device 202. After the lobes or radially extending loops 214 of one or both sides 204, 206 are collapsed, the sheath 322 may be advanced to further constrain the lobes or radially extending loops 214 of one or both sides 204, 206. In certain instances, the lobes or radially extending loops 214 of the second side 206 are collapsed, and the sheath 322 is advanced to constrain the lobes or radially extending loops 214 of the first side 204. The sheath 322 may be advanced to the tip 210. As the he constraining lines 212 are retracted into the catheter 208, the implantable medical device 202 may be collapsed within the sheath 322.

[0045] In one example of a deployment sequence, to deploy the implantable medical device 202, the above note constraining sequence is reversed. Once the tip 210 and catheter 208 is across the septum the sheath 322 is retracted and the lobes or radially extending loops 214 of the first side 204 are deployed. The sheath 322 may be pulled back so that the lobes or radially extending loops 214 of the first side 204 apply tension to the septum. Prior to release of the constraining lines 212 and the release lines 216, the positioning of the implantable medical device 202 can be evaluated. If the positioning is not satisfactory or desirable, the implantable medical device 202 may be reconstrained and repositioned. To reconstrain and reposition the implantable medical device 202, the constraining sequence described above may be followed (e.g., tension may be applied to the one or more constraining lines 212 and the implantable medical device 202 may be retracted within the sheath 322). The second side 206 of the implantable medical device 202 may be deployed by releasing tension applied to the constraining lines 212.

[0046] After the implantable medical device 202 is positioned, the constraining lines 212 and the release lines 216 are released so that the lobes or radially extending loops 214 of the second side 206 are deployed. The release lines 216 are then retracted back to release the constraining loop 320 of the one or more constraining lines 212 from the eyelets 318. The one or more constraining lines 212 and the release lines 216 are coupled to separate pull mechanisms to apply tension to the constraining lines 212 and the release lines 216. This may facilitate simultaneous manipulation of the constraining lines 212 and simultaneous manipulation of the release lines 216. The constraining lines 212 and the release lines 216 can be released simultaneously or individually depending on the deployment to maintain stability of the implantable medical device 202 during deployment.

[0047] In certain instances, the constraining lines 212 are constraining wires (e.g., formed of a metal or metal-type material). In this manner, the constraining lines 212 may have sufficient strength and flexibility to constrain the implantable medical device 202. Using the system 200 as described herein may be beneficial, as compared to a more rigid system, as the deployment system 200 is configured to allow the catheter 208 to be at a smaller acute angle to the septum.

[0048] FIG. 4A is a delivery system 200 including an optional stop 424 and implantable medical device 202 in a first configuration in accordance with an embodiment. During deployment and pull back of the sheath 322, the stop 424 pushes the device out of the sheath 322 as the sheath is retracted.

[0049] In certain instances, the constraining lines 212 may be fixed to catheter 208. To constrain the implantable medical device 202, in these instances, the catheter 208 is pulled back relative to the outer sheath 322. The sheath 322 pulls the lobes or radially extending loops 214 of one or both sides 204, 206 onto itself as shown in FIG. 4B. The stop 424 is configured to limit movement of the implantable medical device 202 in a direction opposite that of a direction tension is applied to the one or more constraining lines 202 or in a direction opposite that of the sheath 322 movement.

[0050] FIG. 5 is a delivery system 200 including an example stop 526 and implantable medical device 202 in accordance with an embodiment. The stop 526 is shown arranged at a distal end of a constraining line 212. In certain instances, each of the one or more constraining lines 212 may include the stop 526. The stop 526 is configured to prevent the distal end of the one or more constraining lines 212 from withdrawing from the one or more eyelets 318 of the implantable medical device 202 prior to removal of the one or more release lines 216.

[0051] To release or deploy the implantable medical device 202, the one or more release lines 216 are withdrawn to release the one or more constraining lines 212. As shown in FIG. 5, the one or more release lines 216 may be arranged through the constraining loop 320 of the one or more constraining lines 212 and maintain contact between the implantable medical device 202 and the one or more constraining lines 212 during deployment. The one or more release lines 216 are withdrawn to through the constraining loop 320 to facilitate release the one or more constraining lines 212.

[0052] FIGS. 6A-C show a delivery system 200 in various stages of deploying an implantable medical device 202 in accordance with an embodiment. As shown in FIG. 6A, the implantable medical device 202 is shown in a delivery or fully collapsed configuration. As shown, the implantable medical device 202 is arranged within a sheath 322.

[0053] The implantable medical device 202 is shown in a partially deployed configuration in FIG. 6B. The implantable medical device 202 may include a first side 204 and a second side 206. The sides 204, 206 are configured to conform to the patient's anatomy (i.e., the first side of the septum, for example). The first side 204 and the second side 206 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 204 from forces acting on the second side 206. As shown in FIG. 6B, the first side 204 is partially deployed. The sheath 322 has been withdrawn to unconstrain the first side 204 of the implantable medical device 202.

[0054] The sheath 322 may be further withdrawn to fully deploy the first side 204 of the implantable medical device 202 as shown in FIG. 6C. The delivery system 200 also includes one or more constraining lines 212 arranged through a portion of the implantable medical device 202. The one or more constraining lines 212 are configured to collapse portions of the implantable medical device 202 (e.g., after the sheath 322 is withdrawn).

[0055] As noted above, the delivery system 200 also includes one or more release lines 216 configured to engage the one or more constraining lines 212 and maintain contact between the implantable medical device 202 and the one or more constraining lines 212 during deployment. The constraining lines 212 and the release lines 216 may facilitate controlled deployment of the second side 206 of the implantable medical device 202. As shown in FIG. 6C, the constraining lines 212 and the release lines 216 may be configured to partially constrain the second side 206 of the implantable medical device 202. The constraining lines 212 and the release lines 216 may be configured to facilitate act as a ramp to guide the implantable medical device 202 from the sheath 322.

[0056] FIG. 7A is another example delivery system 200 and implantable medical device 202 in accordance with an embodiment. The implantable medical device 202 as deployed with the delivery system 200 shown in FIG. 7A may be a replacement heart valve, shunt, stent, stent-graft, or other similar medical device. As shown in FIG. 7A, the implantable medical device 202 is a replacement heart valve. As shown, the implantable medical device 202 is implanted across a native valve 734.

[0057] The delivery system 200 includes a catheter 208 configured to delivery through a patient's vascular to a delivery site. The delivery system 200 includes a tip 210, that may be atraumatic and may be radiopaque, arranged at a distal end of the catheter 208. The delivery system 200 also includes one or more constraining lines 212 arranged through a portion of the implantable medical device 202.

[0058] As shown in FIG. 7A, the implantable medical device 202 includes eyelets 318 arranged about a circumference of the implantable medical device 202. In certain instances, the implantable medical device 202 includes eyelets 318 arranged at a proximal end of the implantable medical device 202. As shown in further detail with reference to FIG. 7B, the one or more constraining lines 212 may be arranged through the eyelets 318. The one or more constraining lines 212 are configured to collapse portions of the implantable medical device 202 toward the catheter 208. Applying tension to an end (not shown) of the constraining lines 212 collapses the implantable medical device 202 toward the catheter 208 for implantation. As discussed in detail above, the delivery system 200 may include a sheath (not shown) configured to hold the implantable medical device 200 in a collapsed configuration. The constraining lines 212 enable recapture of the implantable medical device 200 after initial deployment. Recapture of the implantable medical device 200 using the constraining lines 212 allows for repositioning of the implantable medical device 200.

[0059] The delivery system 200 also includes one or more release lines 216 configured to engage the one or more constraining lines 212 and maintain contact between the implantable medical device 202 and the one or more constraining lines 212 during deployment. To release or deploy the implantable medical device 202, the one or more release lines 216 are withdrawn to release the one or more constraining lines 212 as discussed in further detail above. The one or more release lines 216 are arranged through or coupled to the one or more constraining lines 212 and maintain contact between the implantable medical device 202 and the one or more constraining lines 212 during deployment. The one or more release lines 216 are withdrawn to release the one or more constraining lines 212.

[0060] Tension applied to the constraining lines 212 to collapse portions of the implantable medical device 202 toward the catheter 208. Tension on an end of the constraining lines 212 not arranged with the implantable medical device 202 retracts the constraining lines 212 into the catheter 208. In certain instances, the sheath (not shown) may also be used to facilitate delivery and constrain the implantable medical device 202. As the constraining lines 212 are retracted into the catheter 208, the implantable medical device 202 may be collapsed into the sheath or catheter 208.

[0061] In one example of a deployment sequence, to deploy the implantable medical device 202, the catheter 208 is positioned across the native valve 734, the catheter 208 or a sheath may be retracted to expose a distal portion of the device 202. The catheter 208 may further be retracted to expose the proximal end of the device 202. Prior to release of the constraining lines 212 and the release lines 216, the positioning of the implantable medical device 202 can be evaluated. If the positioning is not satisfactory or desirable, the implantable medical device 202 may be reconstrained and repositioned. To reconstrain and reposition the implantable medical device 202, the constraining sequence described above may be followed (e.g., tension may be applied to the one or more constraining lines 212 and the implantable medical device 202 may be retracted within the sheath or catheter 208). After the implantable medical device 202 is positioned, the constraining lines 212 and the release lines 216 are released.

[0062] In certain instances, the delivery system 200 may include a secondary constraining element 736 (e.g., a hoop, ring, or constraining loops as shown) that may be arranged about the implantable medical device 202. The secondary constraining element 736 may be configured to collapse and expand a distal portion of the implantable medical device 202.

[0063] FIG. 8A is another example delivery system 200 and implantable medical device 202 in accordance with an embodiment. The implantable medical device 202 as deployed with the delivery system 200 shown in FIG. 8A may be a replacement heart valve, shunt, stent, stent-graft, or other similar medical device. As shown in FIG. 8A, the implantable medical device 202 is a replacement heart valve. As shown, the implantable medical device 202 is implanted across a native valve 734.

[0064] The delivery system 200 includes a catheter 208 configured to delivery through a patient's vascular to a delivery site. The delivery system 200 includes a tip 210, that may be atraumatic and may be radiopaque, arranged at a distal end of the catheter 208. The delivery system 200 also includes one or more constraining lines 212 arranged through a portion of the implantable medical device 202.

[0065] As shown in FIG. 8A, the implantable medical device 202 includes eyelets 318 arranged about a circumference of the implantable medical device 202. The eyelets 318 are arranged about a skirt portion 1056 of the implantable medical device 202 that extends from the valve frame structure of the heart valve. In addition and as shown, the constraining liens 212 may be individually arranged through the eyelets 318 and also circumferentially through the eyelets 318 as shown in FIG. 8A.

[0066] The delivery system 200 also includes one or more release lines 216 are configured to engage the one or more constraining lines 212 and maintain contact between the implantable medical device 202 and the one or more constraining lines 212 during deployment. To release or deploy the implantable medical device 202, the one or more release lines 216 are withdrawn to release the one or more constraining lines 212 as discussed in further detail above. The one or more release lines 216 are arranged through or coupled to the one or more constraining lines 212 and maintain contact between the implantable medical device 202 and the one or more constraining lines 212 during deployment. The one or more release lines 216 are withdrawn to release the one or more constraining lines 212.

[0067] Tension applied to the constraining lines 212 to collapse portions of the implantable medical device 202 toward the catheter 208. Tension on an end of the constraining lines 212 not arranged with the implantable medical device 202 retracts the constraining lines 212 into the catheter 208. In certain instances, the sheath (not shown) may also be used to facilitate delivery and constrain the implantable medical device 202. As the constraining lines 212 are retracted into the catheter 208, the implantable medical device 202 may be collapsed into the sheath or catheter 208.

Claims

1. A deployment system (200) for an implantable shunt device (202), the system comprising: an implantable shunt device (202) having a first side (204) and a second side (206), each of the first and second sides including a stent element (222) and a membrane component (224), each of the first and second sides including series of radially extending lobes (214) formed by portions of the stent element (222) and the membrane component (224) and wherein the shunt device further includes a plurality of eyelets (318) arranged on end portions of the lobes; a catheter (208) having a proximal end and a distal end; a tip (210) arranged at the distal end of the catheter; one or more constraining lines (212) arranged through the plurality of eyelets (318) of the implantable shunt device (202), the one or more constraining lines (212) being configured to collapse portions of the implantable shunt device (202) toward the catheter (208); and one or more release lines (216) configured to engage the one or more constraining lines (212) and maintain contact between the implantable shunt device (202) and the one or more constraining lines (212) during deployment, the one or more release lines (216) being partially nested in the tip (210).

2. The system (200) of claim 1, wherein the one or more constraining lines (212) are configured to engage the eyelets (318) on at least a first side (204) of the implantable shunt device (202).

3. The system (200) of any one of claims 1-2, further comprising a sheath (322) arranged about the catheter (208) and configured to capture the implantable shunt device (202) when it is in a collapsed configuration.

4. The system (200) of claim 3, wherein the sheath (322) is configured to constrain the implantable shunt device (202).

5. The system (200) of any one of claims 1-4, wherein the one or more release lines (216) are configured to withdraw to release the one or more constraining lines (212).

6. The system (200) of claim 5, wherein the one or more constraining lines (212) include a constraining loop (320) at a distal end of the one or more constraining lines (212), and the one or more release lines (216) are arranged through the constraining loop (320) of the one or more constraining lines (212) to maintain contact between the implantable shunt device (202) and the one or more constraining lines (212) during deployment.

7. The system (200) of any one of claims 1-6, wherein the one or more constraining lines (212) are one or more constraining wires.

8. The system (200) of any one of claims 1-7, further comprising a stop (424) arranged on the catheter (208) configured to limit movement of the implantable shunt device (202) in a direction opposite that of a direction tension is applied to the one or more constraining lines (212).

9. The system (200) of any one of claims 1-7, further comprising one or more stops (424, 526) arranged at a distal end of the one or more constraining lines (212) and configured to prevent the distal end of the one or more constraining lines (212) from withdrawing from the one or more eyelets (318) of the implantable shunt device (202) prior to removal of the one or more release lines (216).

10. The system (200) of any one of claims 3 or 4 or any one of claims 5-9 when dependent on any one of claims 3 or 4, wherein the one or more release lines (216) are configured to facilitate deployment and act as a ramp to guide the implantable shunt device (202) from the sheath (322).

11. The system (200) of claim 1 comprising: a sheath (322) configured to hold the implantable shunt device (202) in a collapsed configuration; wherein the one or more constraining lines (212) are configured to collapse portions of the implantable shunt device (202) toward the catheter (208) in response to tension applied to the one or more constraining lines (212) and allow expansion of the implantable shunt device (202) in response to release of the tension; and wherein the one or more release lines (216) are further configured to withdraw to release the one or more constraining lines (212) to deploy the implantable shunt device (202) to a deployed configuration, wherein the one or more release lines (216) are coupled to the catheter (208) adjacent the tip (210).

12. The deployment system (200) of claim 11, wherein the eyelets (318) of the implantable shunt device (202) are arranged about a circumference of the implantable shunt device (202).

13. The deployment system (200) of claim 11, wherein each of the one or more constraining lines (212) include a constraining loop (320) at a distal end of the one or more constraining lines (212), and the one or more release lines (216) are arranged through the constraining loop (320) of the one or more constraining lines (212) to maintain contact between the implantable shunt device (202) and the one or more constraining lines (212) during deployment.

14. The deployment system (200) of claim 11, wherein at least one of the one or more constraining lines (212) and the one or more release lines (216) are coupled to the catheter (208) near a distal end thereof.