Implantable medical device deployment system

Abstract

To provide a favorable medical device.SOLUTION: Various aspects of the present disclosure are directed toward apparatuses, systems (200) and methods for deploying a medical device (202). In certain instances, the medical device (202) may be a shunt device. In addition, the apparatuses, systems (200) and methods may include one or more constraining lines (212) arranged through a portion of the implantable medical device (202), and one or more release lines (216) configured to engage the one or more constraining lines (212).SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] Priority claim This application claims the benefit of Provisional Application No. 62 / 699,794, filed July 18, 2018, which is incorporated by reference in its entirety for all purposes.

[0002] Field FIELD OF THE DISCLOSURE This disclosure relates generally to the delivery of implantable medical devices, and more specifically, to methods, systems and apparatus for the delivery of implantable medical devices such as shunts and heart valves. [Background technology]

[0003] background Previous deployment methods for implantable medical devices, such as interatrial shunt devices, have difficulty in properly positioning the device. Furthermore, many of these systems lack the ability to recapture or reposition a deployed device if deployment is not desired. Thus, a need exists for a device delivery system that is robust enough to deliver, reposition, recapture, as needed, and release the device when properly deployed. Summary of the Invention

[0004] Abstract In one example ("Example 1"), a deployment system for an implantable medical device includes a catheter, one or more restraint lines disposed through one or more eyelets of an implantable medical device, where the one or more restraint lines are configured to collapse a portion of the implantable medical device toward the catheter, and one or more release lines configured to engage the one or more restraint lines and maintain contact between the implantable medical device and the one or more restraint lines during deployment.

[0005] In another example ("Example 2"), further to the system of Example 1, the one or more restraining lines are configured to engage an eyelet on at least a first side of the implantable medical device.

[0006] In another example ("Example 3"), in addition to the system of any one of Examples 1-2, the system also includes a sheath disposed around the catheter and configured to capture a folded implantable medical device.

[0007] In another example ("Example 4"), further to the system of Example 3, the sheath is configured to constrain the implantable medical device.

[0008] In another example ("Example 5"), further to the system of any one of Examples 1-4, the one or more release lines are configured to retract to release the one or more restraining lines.

[0009] In another example ("Example 6"), in addition to the system of Example 5, the one or more restraint lines include a restraint loop at a distal end of the one or more restraint lines, and the one or more release lines are disposed through the restraint loops of the one or more restraint lines to maintain contact between the implantable medical device and the one or more restraint lines during deployment.

[0010] In another example ("Example 7"), in addition to the system of any one of Examples 1-6, the one or more restraining lines are one or more restraining wires.

[0011] In another example ("Example 8"), in addition to the system of any one of Examples 1-7, the system also includes a stop disposed on the catheter configured to limit movement of the implantable medical device in a direction opposite to the direction in which tension is applied to the one or more restraint lines.

[0012] In another example ("Example 9"), in addition to the system of any one of Examples 1-7, the system also includes one or more stops positioned distally relative to the distal ends of the one or more restraint lines and configured to prevent the distal ends of the one or more restraint lines from being withdrawn from one or more eyelets of the implantable medical device prior to removal of the one or more release lines.

[0013] In another example ("Example 10"), in addition to the system of any one of Examples 1-9, the one or more release lines are configured to facilitate deployment and act as a ramp to guide the implantable medical device out of the sheath.

[0014] In another example ("Example 11"), in addition to the system of any one of Examples 1-10, the implantable medical device is one of a shunt device, a heart valve, or a valved conduit.

[0015] In one example ("Example 12"), a deployment system includes an implantable medical device, a sheath constructed and arranged to hold the implantable medical device in a collapsed configuration, one or more restraint lines disposed through a portion of the implantable medical device configured to collapse the portion of the implantable medical device toward a catheter in response to tension applied to the one or more restraint lines and to allow expansion of the implantable medical device in response to release of tension, and one or more release lines configured to engage the one or more restraint lines to maintain contact between the implantable medical device and the one or more restraint lines during deployment, and to retract to release the one or more restraint lines to deploy the implantable medical device to a deployed configuration.

[0016] In another example ("Example 13"), in addition to the system of Example 12, the implantable medical device includes an eyelet disposed about the periphery of the implantable medical device, and the one or more restraint lines are disposed through the eyelet.

[0017] In another example ("Example 14"), in addition to the system of Example 12, each of the one or more restraint lines includes a restraint loop at a distal end of the one or more restraint lines, and the one or more release lines are disposed through the restraint loops of the one or more restraint lines to maintain contact between the implantable medical device and the one or more restraint lines during deployment.

[0018] In another example ("Example 15"), in addition to the system of Example 12, at least one of the one or more restraint lines and the one or more release lines is coupled to the catheter near its distal end.

[0019] In another example ("Example 16"), in addition to the system of Example 15, the catheter includes a tip portion coupled to a distal end of the catheter, and at least one of the one or more restraint lines and the one or more release lines are coupled to the catheter adjacent the tip portion.

[0020] In another example ("Example 17"), a method of deploying an implantable medical device includes placing a catheter at a target location with an implantable medical device disposed in a folded configuration within a sheath, allowing expansion of at least a portion of the implantable medical device by releasing tension on one or more restraint lines disposed through one or more eyelets of the implantable medical device, and releasing the one or more restraint lines from the implantable medical device by removing one or more release lines engaged with the one or more restraint lines.

[0021] In another example ("Example 18"), in addition to the method of Example 17, the method also includes advancing the sheath to unfold a first side of the implantable medical device, and allowing expansion of a portion of the implantable medical device includes releasing tension on the one or more restraint lines to allow expansion of a second side of the implantable medical device.

[0022] In another example ("Example 19"), in addition to the method of Example 18, the method also includes reconstraining the implantable medical device by applying tension to the one or more restraint lines and retracting the implantable medical device into a delivery sheath.

[0023] In another example ("Example 20"), in addition to the method of Example 18, the method also includes deploying a second side of the implantable medical device by releasing the tension applied to the restraint line.

[0024] The above examples are merely examples and should not be read to limit or otherwise narrow the scope of any of the inventive concepts provided by this disclosure. While several examples have been 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 should be regarded as illustrative in nature and not as restrictive in nature. [Brief description of the drawings]

[0025] BRIEF DESCRIPTION OF THE DRAWINGS 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.

[0026] [Figure 1] FIG. 1 is an exemplary implantable medical device according to one embodiment.

[0027] [Diagram 2] FIG. 2 is an exemplary delivery system and shunt device according to one embodiment.

[0028] [Figure 3A] FIG. 3A is an exemplary delivery system and shunt device according to one embodiment.

[0029] [Figure 3B] FIG. 3B is a first close-up view of the delivery system and shunt device shown in FIG. 3A, according to one embodiment.

[0030] [Figure 3C] FIG. 3C is a second close-up view of the delivery system and shunt device shown in FIGS. 3A-B, according to one embodiment.

[0031] [Figure 4A] FIG. 4A is an exemplary delivery system and shunt device including a stop in a first configuration, according to one embodiment.

[0032] [Figure 4B] FIG. 4B shows the delivery system and shunt device shown in FIG. 4A in a second configuration, according to one embodiment.

[0033] [Diagram 5] FIG. 5 is another exemplary delivery system and shunt device including a stop, according to one embodiment.

[0034] [Figure 6] 6A-6C show a delivery system at various stages of deploying a shunt device according to one embodiment.

[0035] [Figure 7]FIG. 7 is another exemplary delivery system and implantable medical device, according to one embodiment.

[0036] [Figure 8] FIG. 8 is another exemplary delivery system and implantable medical device, according to one embodiment.

[0037] [Figure 9A] FIG. 9A is another exemplary delivery system and implantable medical device, according to one embodiment.

[0038] [Figure 9B] FIG. 9B is an enlarged view of a portion of the delivery system shown in FIG. 9A.

[0039] [Figure 10] FIG. 10A is another exemplary delivery system and implantable medical device, according to one embodiment.

[0040] FIG. 10B is an enlarged view of a portion of the delivery system shown in FIG. 10A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a limiting manner, for example, the terms used in this application should be read broadly with the meaning that terms of the art are ascribed to such terms.

[0042] With respect to the term imprecision, the terms "about" and "approximately" may be used interchangeably and refer to measurements including the stated measurement and including any measurement reasonably close to the stated measurement. A measurement reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount as would be understood and readily ascertained by one of ordinary skill in the relevant art. Such deviations may result from measurement errors, differences in calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, small adjustments made to optimize performance and / or construction parameters given differences in measurements relative to other components, specific implementation scenarios, imprecise adjustment and / or manipulation of objects by humans or machines, and / or the like. In cases where it is determined that the value of such reasonably small differences cannot be readily ascertained by one of ordinary skill in the relevant art, the terms "about" and "approximately" may be understood to mean ±10% of the stated value.

[0043]

[0044] Description of Various Embodiments Those skilled in the art will readily appreciate that the various aspects of the disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the disclosure, and in that regard, the drawings should not be construed as limiting.

[0045] FIG. 1 illustrates an exemplary implantable medical device 100 according to one embodiment. The implantable medical device 100 is shown implanted within a patient's heart H. The device 100 is shown positioned between the patient's left atrium LA and right atrium RA. In some examples, the device 100 can be used within the heart H, for example, between the left atrium and right atrium LA, RA. As shown, the device 100 generally includes a first frame component 110 positioned on a first side of the septum (e.g., in the right atrium RA), a second frame component 120 positioned on a second side of the septum (e.g., in the left atrium LA), and a conduit 130 extending through the septum. A needle can be used to create an opening in the septum. The implantable medical device 100 can be a shunt device, where the conduit 130 is a fluid flow lumen between the two sides of the implantable medical device 100.

[0046] 2 is an exemplary delivery system 200 and an implantable medical device 202, such as a shunt device, according to one embodiment. The implantable medical device 202 can include a first side 204 and a second side 206. Each side 204, 206 can include 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., for example, a first side of a septum). The first side 204 and the second side 206 can be separate and distinct components with a flexible interconnect connecting the two sides to decouple 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 can be free to move separately from one another in response to movements of the patient's anatomy. In this manner, a force acting on one of the first side 204 and the second side 206 is maintained within the other of the first side 204 and the second side 206. A force acting on one of the first side 204 and the second side 206 may be isolated to the frame component on which the force acts.

[0047] The delivery system 200 includes a catheter 208 configured for delivery through a patient's duct to a delivery site. In certain instances, the delivery system 200 includes a tip 210 disposed at a distal end of the catheter 208, which can be atraumatic and radiopaque. The delivery system 200 can also include one or more restraining lines 212 disposed through a portion of the implantable medical device 202. The one or more restraining lines 212 are configured to collapse the portion of the implantable medical device 202 toward the catheter 208. In certain instances, the implantable medical device 202 includes a series of lobes or radially expanding loops 210. The lobes or radially expanding loops 214 are formed by portions of the stent element 222 and the membrane component 224 and can be on each of the first side 204 and the second side 206. In certain instances, one or more constraint lines 212 are configured to fold lobes or radially expanding loops 214 on one or both sides 204 , 206 toward the catheter 208 .

[0048] The delivery system 200 may also include one or more release lines 216 configured to engage the one or more restraint lines 212 and maintain contact between the implantable medical device 202 and the one or more restraint lines 212 during deployment. In certain examples, the release lines 216 may be embedded or nested within the tip 210. In other examples, a skirt 228 may be disposed proximal to the tip 210. The release lines 216 may be tucked into the skirt 228.

[0049] Examples of materials for the restraining lines 212 or release lines 216 can be metals such as stainless steel, cobalt chrome alloys, and nitinol. The release lines can also be made from high strength polymeric 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 this disclosure. The restraining lines 212 or release lines 216 can also be made from films of Kapton, polymers (e.g., polyetheretherketone (PEEK), laser cut hypotubes or cut polymer tubes, etc.).

[0050] 3A illustrates features of a delivery system 200 and an implantable medical device 202 used in accordance with one embodiment. As shown in FIG. 3A, the implantable medical device 202 is in a partially folded or constrained configuration, with the second side 206 (e.g., the proximal side) folded or constrained. Additionally, the first side 204 and the second side 208 can include eyelets 318.

[0051] In certain instances, the eyelets 318 may be disposed at the ends of the lobes or radially expanding loops 210. In certain instances, each of the lobes or radially expanding loops 210 includes an eyelet 318, and in other instances, selected ones or pairs of the lobes or radially expanding loops 210 include an eyelet 318. Further, the lobes or radially expanding loops 214 on the second side 206 may include an eyelet and the lobes or radially expanding loops 214 on the first side 204 may not include an eyelet 318. In other instances, the lobes or radially expanding loops 210 on the first side 204 may include an eyelet and the lobes or radially expanding loops 214 on the second side 206 may not include an eyelet 318. Further, as shown, the lobes or radially expanding loops 214 on both sides 204, 206 include an eyelet 318.

[0052] In certain instances, as shown in further detail in FIGS. 3B-C , one or more restraint lines 212 are configured to engage with eyelets 318. The restraint lines 212 may be disposed through the eyelets 318. Further, the restraint lines 212 may only engage with (and be disposed through) eyelets 318 on the second (proximal) side 206 of the implantable medical device 202. In other instances, the restraint lines 212 may only engage with (and be disposed through) eyelets 318 on the first (distal) side 204 of the implantable medical device 202. Further, the restraint lines 212 may engage with (and be disposed through) 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 restraint lines 212 and release lines 216 may be disposed through the membrane component 224.

[0053] To release or deploy the implantable medical device 202, the one or more release lines 216 are retracted to release the one or more restraining lines 212. In certain instances, as shown with particular reference to FIG. 3, the one or more restraining lines 212 include a restraining loop 320 at a distal end of the one or more restraining lines 212. The one or more release lines 216 can be placed through the restraining loop 320 of the one or more restraining lines 212 to maintain contact between the implantable medical device 202 and the one or more restraining lines 212 during deployment. The one or more release lines 216 are retracted through the restraining loop 320 to release the one or more restraining lines 212. In certain instances, the implantable medical device 202 includes only a membrane material between the first side 202 and the second side 204. As shown, the release line 216 is configured to act as a ramp to facilitate deployment and guide the implantable medical device 202 out of the sheath. The release line 216 is configured to radially pull down the first side 204 of the implantable medical device 202 .

[0054] Tension is applied to the restraining lines 212 to collapse a portion of the implantable medical device 202 toward the catheter 208. More specifically, the lobes or radially extending loops 214 (radially projecting) on ​​one or both sides 204, 206 are collapsed. Tension on the implantable medical device 202 and the end of the restraining line 212 that is not deployed retracts the restraining line 212 into the catheter 208. In certain instances, a sheath 322 may be used to facilitate delivery and to constrain the implantable medical device 202. After the lobes or radially extending loops 214 on one or both sides 204, 206 are collapsed, the sheath 322 may be advanced to further constrain the lobes or radially extending loops 214 on one or both sides 204, 206. In certain instances, the lobes or radially expanding loops 214 on the second side 206 are collapsed and the sheath 322 is advanced to constrain the lobes or radially expanding loops 214 on the first side 204. The sheath 322 can be advanced to the tip 210. Once the restraining lines 212 are retracted into the catheter 208, the implantable medical device 202 can be collapsed within the sheath 322.

[0055] In one example of a deployment sequence, the above restraint sequence is reversed to deploy the implantable medical device 202. Once the tip 210 and catheter 208 have crossed the septum, the sheath 322 is retracted and the lobes or radially expanding loops 210 on the first side 204 are deployed. The sheath 322 can be pulled back so that the lobes or radially expanding loops 210 on the first side 204 apply tension to the septum. Prior to releasing the restraint lines 212 and release lines 216, the positioning of the implantable medical device 202 can be evaluated. If the positioning is not satisfactory or desired, the implantable medical device 202 can be reconstrained and repositioned. To reconstrain and reposition the implantable medical device 202, the above restraint sequence can be followed (e.g., tension can be applied to one or more restraint lines 212 and the implantable medical device 202 can be retracted into the sheath 322). The second side 206 of the implantable medical device 202 may be deployed by releasing the tension applied to the restraint line 212 .

[0056] After the implantable medical device 202 is positioned, the restraint lines 212 and release lines 216 are released to deploy the lobes or radially expanding loops 214 on the second side 206. The release lines 216 are then pulled back to release the restraint loops 320 of the one or more restraint lines 212 from the eyelets 318. The one or more restraint lines 212 and release lines 216 are coupled to separate tensioning mechanisms to apply tension to the restraint lines 212 and release lines 216. This can facilitate simultaneous manipulation of the restraint lines 212 and simultaneous manipulation of the release lines 216. The restraint lines 212 and release lines 216 can be released simultaneously or individually depending on the deployment to maintain stability of the implantable medical device 202 during deployment.

[0057] In certain instances, the restraining lines 212 are restraining wires (e.g., formed from a metal or metal-type material). In this manner, the restraining lines 212 may have sufficient strength and flexibility to restrain the implantable medical device 202. Using the system 200 as described herein may be beneficial as compared to more rigid systems because the deployment system 200 is configured to place the catheter 208 at a less acute angle relative to the septum.

[0058] 4A is a delivery system 200 including optional element stop 424 and implantable medical device 202 in a first configuration, according to one embodiment. During deployment and retraction of sheath 322, stop 424 pushes the device out of sheath 322 as the sheath is retracted.

[0059] In certain instances, the restraint lines 212 may be secured to the catheter 208. To restrain 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 expanding loops 210 on one or both sides 204, 206 onto itself, as shown in FIG. 4B. The stops 424 are configured to limit movement of the implantable medical device 202 in a direction opposite to the direction that tension is applied to the one or more restraint lines 202 or opposite to the movement of the sheath 322.

[0060] 5 is a delivery system 200 including an exemplary stop 526 and an implantable medical device 202, according to one embodiment. The stop 526 is shown disposed at a distal end of the restraint line 212. In certain instances, each of the one or more restraint lines 212 may include a stop 526. The stop 526 is configured to prevent the distal end of the one or more restraint lines 212 from being pulled out of the one or more eyelets 318 of the implantable medical device 202 prior to removal of the one or more release lines 216.

[0061] To release or deploy the implantable medical device 202, the one or more release lines 216 are withdrawn, releasing the one or more restraint lines 212. As shown in Figure 5, the one or more release lines 216 can be placed through restraint loops 320 of the one or more restraint lines 212 to maintain contact between the implantable medical device 202 and the one or more restraint lines 212 during deployment. The one or more restraint lines 216 are withdrawn through the restraint loops 320 to facilitate the release of the one or more restraint lines 212.

[0062] 6A-C show a delivery system 200 at various stages of deploying an implantable medical device 202, according to one 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 disposed within a sheath 322.

[0063] The implantable medical device 202 is shown in a partially deployed configuration in FIG. 6B. The implantable medical device 202 can 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 can be separate, distinct components with a flexible interconnect connecting the two sides to decouple 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 is retracted to release the constraint on the first side 204 of the implantable medical device 202.

[0064] The sheath 322 can be further retracted to fully deploy the first side 204 of the implantable medical device 202, as shown in Figure 6C. The delivery system 200 can also include one or more restraint lines 212 disposed through a portion of the implantable medical device 202. The one or more restraint lines 212 are configured to collapse a portion of the implantable medical device 202 (e.g., after the sheath 322 is retracted).

[0065] As described above, the delivery system 200 may also include one or more release lines 216 configured to engage the one or more restraint lines 212 and maintain contact between the implantable medical device 202 and the one or more restraint lines 212 during deployment. The restraint 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 restraint lines 212 and the release lines 216 may be configured to partially restrain the second side 206 of the implantable medical device 202. The restraint lines 212 and the release lines 216 may be configured to facilitate acting as a ramp to guide the implantable medical device 202 out of the sheath 322.

[0066] Figure 7 is another exemplary delivery system 200 and implantable medical device 202, according to one embodiment. The implantable medical device 202 as deployed with the delivery system 200 shown in Figure 7 can be a replacement heart valve, a shunt, a stent, a stent graft, a valved conduit, or other similar medical device. As shown in Figure 7, the implantable medical device 202 is a replacement heart valve. As shown, the implantable medical device 202 is implanted across a native valve 734.

[0067] The delivery system 200 includes a catheter 208 configured for delivery through a patient's duct to a delivery site. In certain instances, the delivery system 200 includes a tip 210, which can be atraumatic and radiopaque, disposed at a distal end of the catheter 208. The delivery system 200 can also include one or more restraining lines 212 disposed through a portion of the implantable medical device 202. As shown in FIG. 7, the implantable medical device 202 includes an eyelet 318 disposed about the periphery of the implantable medical device 202. In certain instances, the implantable medical device 202 includes an eyelet 318 disposed at a distal end of the implantable medical device 202, as shown. In other instances, the implantable medical device 202 includes an eyelet 318 disposed at a proximal end of the implantable medical device 202. Additionally, the implantable medical device 202 can include eyelets 318 disposed at both the distal and proximal ends of the implantable medical device 202. In instances where the implantable medical device 202 does not include eyelets 318 , the restraint lines 212 and release lines 216 may be disposed through a stent or membrane component of the implantable medical device 202 .

[0068] One or more restraining lines 212 may be disposed through the eyelets 318 and configured to collapse a portion of the implantable medical device 202 toward the catheter 208. The one or more restraining lines 212 may extend into or be attached to the catheter 208 distal to the eyelets 318. The restraining lines 212 may enter or be attached to the catheter 208 proximal to the tip 210. Application of tension to the ends (not shown) of the restraining 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 restraining lines 212 allow for recapture of the implantable medical device 200 after initial deployment. Recapture of the implantable medical device 200 using the restraining lines 212 allows for repositioning of the implantable medical device 200.

[0069] Additionally, the delivery system 200 may include a secondary restraint element 736 (e.g., a hoop, ring, or other element) that may be disposed about the implantable medical device 202. One or more of the restraint lines 212 may additionally or alternatively be disposed with or coupled to the secondary restraint element 736 (rather than the eyelet 318) to facilitate folding and expanding the implantable medical device 202. The delivery systems 200 discussed with reference to Figures 2-6 and 8-10 may also utilize the secondary restraint element 736.

[0070] Figure 8 is another exemplary delivery system 200 and implantable medical device 202, according to one embodiment. The implantable medical device 202 as deployed with the delivery system 200 shown in Figure 7 can be a replacement heart valve, a shunt, a stent, a stent graft, a valved conduit, or other similar medical device. As shown in Figure 8, the implantable medical device 202 is a replacement heart valve.

[0071] The delivery system 200 includes a catheter 208 configured for delivery through a patient's duct to a delivery site. In certain instances, the delivery system 200 includes a tip 210, which can be atraumatic and radiopaque, disposed at a distal end of the catheter 208. The delivery system 200 can also include one or more restraining lines 212 disposed about a portion of the implantable medical device 202. As shown in FIG. 8, the implantable medical device 202 includes an eyelet 318 disposed about a periphery of the implantable medical device 202. In certain instances, the implantable medical device 202 includes an eyelet 318 disposed at a distal end of the implantable medical device 202 as shown. In other instances, the implantable medical device 202 includes an eyelet 318 disposed at a proximal end of the implantable medical device 202. Additionally, the implantable medical device 202 can include eyelets 318 disposed at both the distal and proximal ends of the implantable medical device 202. In instances where the implantable medical device 202 does not include eyelets 318 , the restraint lines 212 and release lines 216 may be disposed through a stent or membrane component of the implantable medical device 202 .

[0072] One or more restraint lines 212 may be disposed through the eyelets 318 and configured to collapse a portion of the implantable medical device 202 toward the catheter 208. The one or more restraint lines 212 may be a single line extending around the implantable medical device 202. Application of tension to the ends (not shown) of the multiple restraint lines 212 or the single restraint line 212 causes the implantable medical device 202 to collapse 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 restraint lines 212 allow for recapture of the implantable medical device 200 after initial deployment. Recapture of the implantable medical device 200 using the restraint lines 212 allows for repositioning of the implantable medical device 200.

[0073] Figure 9A is another exemplary delivery system 200 and implantable medical device 202, according to one embodiment. The implantable medical device 202 as deployed with the delivery system 200 shown in Figure 9A can be a replacement heart valve, a shunt, a stent, a stent-graft, or other similar medical device. As shown in Figure 9A, the implantable medical device 202 is a replacement heart valve. As shown, the implantable medical device 202 is implanted across a native valve 734.

[0074] The delivery system 200 includes a catheter 208 configured for delivery through a patient's duct to a delivery site. In certain examples, the delivery system 200 includes a tip 210, which can be atraumatic and radiopaque, disposed at a distal end of the catheter 208. The delivery system 200 can also include one or more restraint lines 212 disposed through a portion of the implantable medical device 202.

[0075] As shown in FIG. 9A, the implantable medical device 202 includes eyelets 318 disposed about the periphery of the implantable medical device 202. In certain instances, the implantable medical device 202 includes eyelets 318 disposed at a proximal end of the implantable medical device 202. As shown in further detail with reference to FIG. 9B, one or more restraining lines 212 can be disposed through the eyelets 318. The one or more restraining lines 212 are configured to collapse a portion of the implantable medical device 202 toward the catheter 208. Application of tension to an end (not shown) of the restraining lines 212 collapses the implantable medical device 202 toward the catheter 208 for implantation. As discussed in detail above, the delivery system 200 can include a sheath (not shown) configured to hold the implantable medical device 200 in a collapsed configuration. The restraining lines 212 allow for recapture of the implantable medical device 200 after initial deployment. Recapture of the implantable medical device 200 using the restraint lines 212 allows for repositioning of the implantable medical device 200 .

[0076] The delivery system 200 may also include one or more release lines 216 configured to engage the one or more restraint lines 212 and maintain contact between the implantable medical device 202 and the one or more restraint lines 212 during deployment. To release or deploy the implantable medical device 202, the one or more release lines 216 are retracted and the one or more restraint lines 212 are released, as discussed in further detail above. The one or more release lines 216 may be disposed through or coupled to the one or more restraint lines 212 to maintain contact between the implantable medical device 202 and the one or more restraint lines 212 during deployment. The one or more release lines 216 are retracted and the one or more restraint lines 212 are released.

[0077] Tension is applied to the restraining line 212 to collapse a portion of the implantable medical device 202 towards the catheter 208. Tension on the end of the restraining line 212 that is not positioned with the implantable medical device 202 retracts the restraining line 212 into the catheter 208. In certain instances, a sheath (not shown) may be used to facilitate delivery and to constrain the implantable medical device 202. When the restraining line 212 is retracted into the catheter 208, the implantable medical device 202 may collapse into the sheath or catheter 208.

[0078] In one example of a deployment sequence, to deploy the implantable medical device 202, the catheter 208 is positioned across the native valve 734, and the catheter 208 or sheath can be retracted to expose a distal portion of the device 202. The catheter 208 can be further retracted to expose a proximal end of the device 202. Prior to releasing the restraint lines 212 and release lines 216, the positioning of the implantable medical device 202 can be evaluated. If the positioning is not satisfactory or desired, the implantable medical device 202 can be reconstrained and repositioned. To reconstrain and reposition the implantable medical device 202, the restraint sequence described above can be followed (e.g., tension can be applied to one or more of the restraint lines 212 and the implantable medical device 202 can be retracted into the sheath or catheter 208). After the implantable medical device 202 is positioned, the restraint lines 212 and release lines 216 are released.

[0079] In certain examples, the delivery system 200 can include a secondary restraint element 736 (e.g., a hoop, ring, or a restraining loop as shown) that can be disposed around the implantable medical device 202. The secondary restraint element 736 can be configured to collapse and expand a distal portion of the implantable medical device 202.

[0080] Figure 10A is another exemplary delivery system 200 and implantable medical device 202, according to one embodiment. The implantable medical device 202 as deployed with the delivery system 200 shown in Figure 10A can be a replacement heart valve, a shunt, a stent, a stent-graft, or other similar medical device. As shown in Figure 10A, the implantable medical device 202 is a replacement heart valve. As shown, the implantable medical device 202 is implanted across a native valve 734.

[0081] The delivery system 200 includes a catheter 208 configured for delivery through a patient's duct to a delivery site. In certain examples, the delivery system 200 includes a tip 210, which can be atraumatic and radiopaque, disposed at a distal end of the catheter 208. The delivery system 200 can also include one or more restraint lines 212 disposed through a portion of the implantable medical device 202.

[0082] 10A, the implantable medical device 202 includes eyelets 318 disposed about the implantable medical device 202. The eyelets 318 are disposed about a skirt portion 1056 of the implantable medical device 202 that extends from a valve framework structure of the heart valve. Additionally, as shown, the restraint lines 212 can be individually disposed through the eyelets 318 and also circumferentially disposed through the eyelets 318, as shown in FIG.

[0083] The delivery system 200 may also include one or more release lines 216 configured to engage the one or more restraint lines 212 and maintain contact between the implantable medical device 202 and the one or more restraint lines 212 during deployment. To release or deploy the implantable medical device 202, the one or more release lines 216 are retracted and the one or more restraint lines 212 are released, as discussed in further detail above. The one or more release lines 216 may be disposed through or coupled to the one or more restraint lines 212 to maintain contact between the implantable medical device 202 and the one or more restraint lines 212 during deployment. The one or more release lines 216 are retracted and the one or more restraint lines 212 are released.

[0084] Tension is applied to the restraining line 212 to collapse a portion of the implantable medical device 202 towards the catheter 208. Tension on the end of the restraining line 212 that is not positioned with the implantable medical device 202 retracts the restraining line 212 into the catheter 208. In certain instances, a sheath (not shown) may be used to facilitate delivery and to constrain the implantable medical device 202. Once the restraining line 212 is retracted into the catheter 208, the implantable medical device 202 may be collapsed into the sheath or catheter 208.

[0085] The invention of this application has been described above both generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the present disclosure. Therefore, the embodiments are intended to cover the modifications and variations of the present invention provided they fall within the scope of the appended claims and their equivalents. (Aspect) (Aspect 1) A catheter; one or more restraining lines disposed through one or more eyelets of the implantable medical device; one or more release lines configured to engage the one or more restraint lines and maintain contact between the implantable medical device and the one or more restraint lines during deployment; 1. A deployment system for an implantable medical device, comprising: A system for deploying an implantable medical device, wherein the one or more restraint lines are configured to collapse a portion of the implantable medical device toward the catheter. (Aspect 2) 2. The system of embodiment 1, wherein the one or more restraining lines are configured to engage with an eyelet on at least a first side of the implantable medical device. (Aspect 3) The system of any one of embodiments 1-2, further comprising a sheath disposed around the catheter and configured to capture the folded implantable medical device. (Aspect 4) 4. The system of embodiment 3, wherein the sheath is configured to constrain the implantable medical device. (Aspect 5) 5. The system of any one of aspects 1-4, wherein the one or more release lines are configured to retract to release the one or more restraining lines. (Aspect 6) The system of embodiment 5, wherein the one or more restraint lines include a restraint loop at a distal end of the one or more restraint lines, and the one or more release lines are positioned through the restraint loops of the one or more restraint lines to maintain contact between the implantable medical device and the one or more restraint lines during deployment. (Aspect 7) The system of any one of embodiments 1-6, wherein the one or more restraining lines are one or more restraining wires. (Aspect 8) The system of any one of aspects 1-7, further comprising a stop disposed on the catheter configured to limit movement of the implantable medical device in a direction opposite to the direction in which tension is applied to the one or more restraint lines. (Aspect 9) The system of any one of aspects 1-7, further comprising one or more stops positioned distal to the distal end of the one or more restraint lines and configured to prevent the distal end of the one or more restraint lines from being withdrawn from one or more eyelets of the implantable medical device prior to removal of the one or more release lines. (Aspect 10) The system of any one of embodiments 1-9, wherein the one or more release lines are configured to facilitate deployment and act as a ramp to guide the implantable medical device out of the sheath. (Aspect 11) The system of any one of aspects 1-10, wherein the implantable medical device is one of a shunt device, a heart valve, or a valved conduit. (Aspect 12) Implantable medical devices; a sheath constructed and arranged to hold the implantable medical device in a collapsed configuration; one or more restraint lines disposed through a portion of the implantable medical device configured to collapse the portion of the implantable medical device toward the catheter in response to tension applied to the one or more restraint lines and to allow expansion of the implantable medical device in response to release of tension; one or more release lines configured to engage the one or more restraint lines, maintain contact between the implantable medical device and the one or more restraint lines during deployment, and retract to release the one or more restraint lines to deploy the implantable medical device to a deployed configuration; A deployment system, including: (Aspect 13) 13. The deployment system of embodiment 12, wherein the implantable medical device includes an eyelet disposed about a periphery of the implantable medical device, the one or more restraint lines being disposed through the eyelet. (Aspect 14) The deployment system of embodiment 12, wherein each of the one or more restraint lines includes a restraint loop at a distal end of the one or more restraint lines, and the one or more release lines are positioned through the restraint loops of the one or more restraint lines to maintain contact between the implantable medical device and the one or more restraint lines during deployment. (Aspect 15) 13. The deployment system of claim 12, wherein at least one of the one or more restraint lines and the one or more release lines are coupled to the catheter near its distal end. (Aspect 16) The deployment system of aspect 15, wherein the catheter includes a tip portion coupled to a distal end of the catheter, and at least one of the one or more restraint lines and the one or more release lines are coupled to the catheter adjacent the tip portion. (Aspect 17) placing the catheter at the target location with the implantable medical device disposed in a folded configuration within the sheath; allowing expansion of at least a portion of the implantable medical device by releasing tension on one or more restraint lines disposed through one or more eyelets of the implantable medical device; releasing the one or more restraint lines from the implantable medical device by removing one or more release lines engaged with the one or more restraint lines; A method for deploying an implantable medical device comprising: (Aspect 18) The method of embodiment 17, further comprising advancing the sheath to unfold a first side of the implantable medical device, and allowing expansion of a portion of the implantable medical device comprises releasing tension on the one or more restraint lines to allow expansion of a second side of the implantable medical device. (Aspect 19) The method of embodiment 18, further comprising reconstraining the implantable medical device by applying tension to the one or more restraint lines and retracting the implantable medical device into a delivery sheath. (Aspect 20) The method of embodiment 18, further comprising deploying a second side of the implantable medical device by releasing tension applied to the restraint line.

Claims

1. A catheter; an implantable medical device disposed on the catheter, the medical device including one or more eyelets; one or more restraint lines disposed through the one or more eyelets of the implantable medical device; one or more stops disposed on the one or more tether lines and configured to limit withdrawal of the one or more tether lines from the one or more eyelets; one or more release lines configured to engage the one or more restraint lines and maintain contact between the implantable medical device and the one or more restraint lines during deployment; 1. A deployment system for an implantable medical device, comprising: the one or more constraint lines are configured to fold a portion of the implantable medical device toward the catheter; A system for deploying an implantable medical device, wherein the one or more release lines are configured to be tensioned and retracted to release the one or more restraint lines.

2. The system of claim 1 , wherein the one or more restraining lines include one or more restraining loops, and the one or more release lines are disposed through the one or more restraining loops.

3. The system of claim 2 , wherein the one or more release lines maintain contact between the implantable medical device and the one or more restraint lines during deployment.

4. The system of claim 3 , wherein the one or more release lines are configured to be retrieved through the one or more restraining loops to facilitate release of the one or more restraining lines.

5. The system of any one of claims 1 to 4, wherein the one or more release lines are configured to retract to release the one or more restraining lines.

6. The system of any one of claims 1 to 5, wherein the stop is positioned distal to a distal end of the one or more restraint lines and configured to prevent the distal end of the one or more restraint lines from being withdrawn from one or more eyelets of the implantable medical device prior to removal of the one or more release lines.

7. The system of any one of claims 1 to 6, wherein the one or more release lines are configured to facilitate deployment and act as a ramp to guide the implantable medical device out of a sheath.

8. The system of any one of claims 1 to 7, wherein the implantable medical device is one of a shunt device, a heart valve, or a valved conduit.

9. an implantable medical device defining a perimeter, the implantable medical device including eyelets disposed about the perimeter of the implantable medical device; a sheath constructed and arranged to hold the implantable medical device in a collapsed configuration; one or more restraint lines disposed through the eyelets of the implantable medical device, the one or more restraint lines configured to collapse a portion of the implantable medical device toward the catheter in response to tension applied to the one or more restraint lines and to allow expansion of the implantable medical device in response to release of tension; one or more release lines configured to engage the one or more restraint lines, maintain contact between the implantable medical device and the one or more restraint lines during deployment, and retract to release the one or more restraint lines to deploy the implantable medical device to a deployed configuration; one or more stops disposed on the one or more tether lines and configured to limit withdrawal of the one or more tether lines from the one or more eyelets; Including, the one or more release lines are configured to be tensioned and retracted to release the one or more restraining lines; the one or more release lines are at least partially nested within the distal end of the catheter; the one or more restraint lines include a restraint loop at a distal end of the one or more restraint lines, the one or more release lines being disposed through the restraint loop of the one or more restraint lines to maintain contact between the implantable medical device and the one or more restraint lines during deployment; A deployment system, wherein the implantable medical device further comprises a membrane and a frame, and the restraining loops of the one or more restraining lines are positioned through the one or more eyelets such that the one or more release lines are located only on the exterior of the frame.

10. The deployment system of claim 9 , wherein the eyelet is disposed at a proximal end of the implantable medical device.

11. 10. The deployment system of claim 9, wherein the one or more tether lines are disposed through the eyelets.

12. The deployment system of claim 1 or 9, wherein the one or more stops are disposed at a distal end of the one or more restraining lines.

13. The deployment system of claim 1 or 9, wherein the one or more stops are disposed around or about the one or more restraining lines.

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