Systems and methods for constructing constraint mechanisms on devices

Abstract

To provide a system that forms a good restraint mechanism. Various aspects of the present disclosure are directed to devices, systems, and methods that include forming a restraining mechanism for delivery of an implantable medical device, the devices, systems, and methods can include reducing the diameter of the implantable medical device from a deployed diameter to a reduced diameter and interlocking one or more fibers along a length of the implantable medical device while the implantable medical device is at the reduced diameter to form the restraining mechanism.

Description

[Technical field]

[0001] Field The present disclosure relates to apparatus, systems and methods that include constructing a covering for use in the delivery of an implantable medical device, and more particularly, the present disclosure relates to apparatus, systems and methods that include constructing a covering for constraining an expandable device during delivery of the device. [Background technology]

[0002] background Stents and stent grafts may be utilized to provide radial support to various tubular passageways within the body, including arteries, veins, airways, gastrointestinal tracts, and biliary tracts. The preferred method for placing these devices has been to precisely position and deploy the device at the treatment site using specialized delivery systems. These delivery systems allow the practitioner to minimize the trauma and technical difficulties associated with device placement. Attributes of the delivery systems include low profile, ability to pass through introducer sheaths, ability to navigate smoothly and atraumatically through tortuous ductal systems, protection of constrained devices, and ability to precisely position and deploy the device.

[0003] A stent or stent-graft may be deployed and plastically deformed by using an inflatable balloon (e.g., a balloon-expandable stent) or by self-expanding and elastically recovering from a collapsed or constrained delivery diameter to an expanded and deployed diameter (e.g., a "self-expandable" stent). Some stents are designed to be manufactured at a functional diameter from a material with elastic recovery properties and then elastically recover by being radially compressed and mounted on a delivery catheter.

[0004] These stent and stent-graft devices may be held, compressed or restrained in a delivery configuration prior to and during delivery to the target location. The devices may be held in this compressed state for extended periods of time (e.g., after manufacture and before use). Different mechanisms or devices may be used to hold the stent and stent-graft devices in the delivery state and release them to allow expansion of the stent and stent-graft devices at the target location. Summary of the Invention

[0005] Abstract According to one example ("Example 1"), a method of forming a restraining mechanism for delivery of an implantable medical device includes reducing a diameter of an implantable medical device from a deployed diameter to a reduced diameter, circumferentially wrapping one or more fibers around the implantable medical device, and interlocking the one or more fibers along a length of the implantable medical device while the implantable medical device is at the reduced diameter to form a restraining mechanism.

[0006] According to another example ("Example 2"), further to Example 1, interlocking the one or more fibers along a length of the implantable medical device includes braiding the one or more fibers to form a restraining mechanism.

[0007] According to another example ("Example 3"), in addition to any one of Examples 1-2, interlocking the one or more fibers along a length of the implantable medical device includes forming a knot by braiding the one or more fibers.

[0008] According to another example ("Example 4"), in addition to any one of Examples 1-3, interlocking the one or more fibers includes braiding the one or more fibers together while the one or more fibers are in direct contact with the implantable medical device.

[0009] According to another example ("Example 5"), in addition to any one of Examples 1-4, reducing the diameter of the implantable medical device includes forcing the implantable medical device through a funnel having an inner surface with a reducing diameter.

[0010] According to another example ("Example 6"), further to Example 5, interlocking the one or more fibers includes disposing one or more fibers along the implantable medical device as the implantable medical device exits the funnel at a reduced diameter.

[0011] According to another example ("Example 7"), in addition to any one of Examples 5-6, the funnel includes an inner surface that reduces an inner diameter of the funnel and a braided zone having a length approximately equal to a length of the implantable medical device.

[0012] According to another example ("Example 8"), in addition to any one of Examples 5-7, the method further includes disposing one or more fibers around an outer surface of the funnel and dragging the one or more fibers along the outer surface of the funnel toward an end of the funnel, where the implantable medical device exits the funnel at a reduced diameter and engages with the implantable medical device.

[0013] According to another example ("Example 9"), any one of Examples 1-7, further comprising interlocking one or more fibers in a first direction along a length of the implantable medical device to form a first layer of a restraining mechanism, and interlocking the one or more fibers back over the first layer in a second direction along the length of the implantable medical device to form a second layer of a restraining mechanism.

[0014] According to another example ("Example 10"), in addition to any one of Examples 1-8, interlocking the one or more fibers includes braiding the one or more fibers together using a braider.

[0015] According to another example ("Example 11"), further to Example 9, the braider includes one or more needles, the one or more needles equal one or more fibers, and interlocking the one or more fibers includes braiding the one or more fibers together with the one or more needles.

[0016] According to one example ("Example 12"), a system for forming a restraining mechanism for delivery of an implantable medical device includes a funnel configured to reduce a diameter of the implantable medical device from a deployed diameter to a reduced diameter, and a braider configured to interlock one or more fibers along a length of the implantable medical device while the implantable medical device is at the reduced diameter to form a restraining mechanism.

[0017] According to another example ("Example 13"), further to Example 12, the funnel includes an inner surface that reduces an inner diameter of the funnel and a braided zone having a length approximately equal to a length of the implantable medical device.

[0018] According to another example ("Example 14"), in addition to any one of Examples 12-13, the braider includes one or more needles, the one or more needles being equal to the one or more fibers, and interlocking the one or more fibers includes braiding the one or more fibers together by the one or more needles.

[0019] According to another example ("Example 15"), in addition to any one of Examples 12-14, the funnel is configured to facilitate placement of one or more fibers on the implantable medical device to interlock the one or more fibers.

[0020] According to one example ("Example 16"), a method includes loading an implantable medical device into a funnel having an inner surface and a braided zone that reduces the inner diameter of the funnel, reducing a diameter of the implantable medical device by forcing the implantable medical device through the inner surface that reduces the inner diameter of the funnel, and applying one or more fibers to the implantable medical device as it exits the braided zone of the funnel to maintain the implantable medical device at the reduced diameter.

[0021] According to another example ("Example 17"), in addition to Example 16, applying the one or more fibers includes tying a single fiber together to form a restraining mechanism.

[0022] According to another example ("Example 18"), in addition to Example 16, applying the one or more fibers includes braiding two or more fibers together to form the restraining mechanism.

[0023] According to another example ("Example 19"), further to Example 16, the method includes disposing one or more fibers around an outer surface of the funnel and dragging the one or more fibers along the outer surface of the funnel toward an end of the funnel, where the implantable medical device exits the funnel with a reduced diameter to engage the implantable medical device.

[0024] According to another example ("Example 20"), further to Example 16, applying the one or more fibers includes interlocking the one or more fibers in a first direction along a length of the implantable medical device to form a first layer of a restraining mechanism, and further includes interlocking the one or more fibers back over the first layer in a second direction along the length of the implantable medical device to form a second layer of a restraining mechanism. [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 a top view of a catheter with a restraining mechanism, according to some embodiments.

[0027] [Figure 2A] FIG. 2A is a side view of an exemplary funnel for reducing an implantable medical device to a reduced diameter, according to some embodiments.

[0028] [Figure 2B] FIG. 2B is a partial cross-sectional view of the funnel shown in FIG. 2A.

[0029] [Figure 3A] FIG. 3A is an exemplary blader and implantable medical device, according to some embodiments.

[0030] [Figure 3B] FIG. 3B is another exemplary braider and implantable medical device, according to some embodiments.

[0031] [Figure 4] FIG. 4 is an exemplary single fiber restraint mechanism, according to some embodiments.

[0032] [Diagram 5] FIG. 5 is an exemplary multi-fiber restraining mechanism, according to some embodiments.

[0033] 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. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] Detailed Description Those skilled in the art will readily appreciate that the various aspects of the present 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 present disclosure, and in that regard, the drawings should not be construed as limiting.

[0035] Various aspects of the present disclosure are directed to apparatus, systems, and methods that include forming or manufacturing a restraining mechanism configured to hold, compress, or restrain an implantable medical device (e.g., a stent, stent graft, balloon, or other expandable medical device) in a delivery configuration prior to and during delivery to a target location. In certain instances, the restraining mechanism includes one or more fibers.

[0036] The restraining mechanism according to various aspects of the present disclosure can be formed or manufactured directly on the implantable medical device. One or more fibers are braided, sewn or interlocked to form the restraining mechanism. Thus, one or more fibers are braided, sewn or interlocked together around or around the implantable medical device. As described above, the implantable medical device is reduced to a reduced (delivery) diameter and folded or restrained by the restraining mechanism for delivery to a target location in a patient where it is deployed or expanded to a deployed diameter (larger than the reduced diameter). As a result, in certain instances, one or more fibers are interlocked, braided or sewn on the implantable medical device while the device is at the reduced (delivery) diameter.

[0037] Certain prior restraint mechanisms that use fibers are braided or interlocked prior to being applied to or disposed around the implantable medical device. Prior restraint mechanisms are formed as separate components and added as a separate step in the manufacturing process. In comparison to these prior restraint mechanisms, for example, processing steps are eliminated by forming the fiber restraint mechanism directly on the implantable medical device. Eliminating steps in the process can reduce the opportunity for error or failure in the loading process, such as improper restraint mechanism placement or damage to the implantable medical device (e.g., bending of stent struts, breakage of stent struts, entanglement of fibers, improper length of restraint mechanism such as fiber length, improper layering of fibers).

[0038] Figure 1 is a top view of a catheter 100 with a restraining mechanism 102, according to some embodiments. As shown in Figure 1, the restraining mechanism 102 is configured to restrain an expandable medical device 104 in a delivery configuration. The restraining mechanism 102 can include one or more fibers 106 disposed about the expandable medical device 104 to maintain the restraining mechanism 102 in the restrained configuration.

[0039] The restraining mechanism 102 is disposed along the length of the expandable medical device 104. The restraining mechanism 102 can also be disposed circumferentially around the expandable medical device 104 to substantially cover the expandable medical device 104 for delivery. The one or more fibers 106 can be disposed within a lumen (not shown) of the catheter 100 and extend toward a proximal end of the catheter 100 that is disposed outside of the patient during delivery of the expandable medical device 104. The one or more fibers 106 include a proximal end 108 to which a user can apply tension to release the restraining mechanism 102 and deploy the expandable medical device 104.

[0040] In certain instances, one or more fibers 106 are released similar to a ripcord, such that interlocking portions (e.g., overlapping fibers or knots) are released sequentially along the length of the expandable medical device 104. As described in more detail below, the restraining mechanism 102 is formed by interlocking one or more fibers 106 together directly on the expandable medical device 104. In comparison to previous multi-fiber restraining mechanisms that are woven together and then placed around a constrained device, the restraining mechanism 102 is formed directly on the expandable medical device 104. The expandable medical device 104 can be a stent, stent graft, balloon, or similar device.

[0041] FIG. 2A is an exemplary funnel 200 for reducing an implantable medical device 104 to a reduced diameter, according to some embodiments. The funnel 200 is configured to reduce the diameter of the implantable medical device 104 from a deployed (or expanded) diameter to a reduced diameter. As shown in FIG. 2B, the funnel 200 includes an inner surface 204 that reduces the inner diameter of the funnel 200 and a braided zone 206. The implantable medical device 104 is shown with a portion of the expanded diameter (between the inner surface 204 that reduces the inner diameter of the funnel 200) and a portion of the reduced diameter (between the inner surfaces of the braided zone 206). The braided zone 206 is described as a landing point for one or more fibers 304 when forming the restraining mechanism 102, and may consist of an extension of the funnel 200, as shown in FIG. 3A. The braided zone 206 may also consist of only the restrained device 104 as it passes through the exit point 212 of the funnel 200. The braided zones can be different lengths, for example, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 110%, 120%, 130%, 140%, 150% or any length in between of the length of the implantable medical device.

[0042] In certain cases, the inner surface 204 of the funnel 200, which is reduced in diameter, can be tapered. Moreover, the tapered inner surface 204 leads directly into the braided zone 206 of the funnel 200. The inner surface 204 of the braided zone 206 of the funnel 200 can be substantially linear. The implantable medical device 104 can be loaded into the funnel 200 at an entry point 210. Upon being loaded into the funnel 200 through the entry point 210 of the funnel 200, the tapered inner surface 204 forces the implantable medical device 104 into a constrained configuration, where the implantable medical device 104 is reduced in diameter. The implantable medical device 104 is forced through the braided zone 206 of the funnel 200 and extrudes out of the exit point 212 of the funnel 200.

[0043] 2A-B, the exterior surface 208 of the funnel 200 includes a taper similar to the interior surface 204 of the funnel. However, the exterior surface 208 of the funnel 200 in the braided zone 206 may also include a taper that is less than the taper of the remainder of the exterior surface 208 of the funnel 200. The exterior surface 208 of the funnel 200 tapers until an inflection point 214. At the inflection point 214, the exterior surface 208 may transition from a greater taper to a lesser taper, or the exterior surface 208 may transition from a taper to a substantially linear surface.

[0044] In certain instances, the funnel 200 is configured to facilitate placement of one or more fibers (forming a restraining mechanism) on the implantable medical device 104 to interlock the one or more fibers, as discussed below with reference to FIG. 3. The inflection point 214 can serve as a landing point for one or more fibers, which can slide down the exterior surface 208 toward an exit point 212 of the funnel 200. As the implantable medical device 104 is forced through the exit point 212 of the funnel 200, the one or more fibers slide off the exterior surface 208 and engage with the implantable medical device 104. In certain instances, the one or more fibers engage the implantable medical device 104 under tension to maintain the implantable medical device 104 at a reduced diameter.

[0045] 3A-B show an exemplary funnel 200, restraining mechanism 102, and implantable medical device 104, according to some embodiments. One or more fibers 304 may be disposed at the exit point 212 of the funnel 200, as described in detail above with reference to FIG. 2. As shown in FIGS. 3A-3B, the implantable medical device 104 is in a reduced diameter or restrained configuration upon exiting the funnel 200. The funnel 200 may include a tapered outer profile at the distal end (e.g., as shown in FIG. 3A) or may not include an outer taper (e.g., as shown in FIG. 3B). As shown by comparing FIGS. 3A and 3B, the funnel 200 shown in FIG. 3A includes an inflection point 214 and a braided zone 206, as discussed in more detail above with reference to FIGS. 2A-B, while the funnel 200 shown in FIG. 3B does not include these aspects.

[0046] The braider 300 and funnel 200 can form a system for forming a restraining mechanism for delivery of an implantable medical device. In certain instances, the braider 300 is configured to interlock one or more fibers 304 along the length of the implantable medical device 104 while the implantable medical device 104 is at a reduced diameter to form a restraining mechanism. Additionally, the one or more fibers 304 can be wrapped circumferentially around the implantable medical device 104.

[0047] In certain instances, one or more fibers 304 are interlocked using one or more needles 306 (or other similar braiding structures such as elongate elements or tools). The number of needles 306 can be equal to the number of fibers 304 used by the braider 300. Furthermore, the one or more fibers 304 interlocked together form a restraining mechanism 102. The restraining mechanism 102 as shown in FIG. 3 holds the implantable medical device 104 in a collapsed configuration.

[0048] Certain prior restraining mechanisms using fibers are braided or formed prior to being applied to or disposed around the implantable medical device. The prior restraining mechanism is formed as a separate component and added as a separate step in the manufacturing process. Forming the restraining mechanism 102 in this manner allows for tighter restraint, in addition to reducing manufacturing steps by the braider 300 (and funnel 200) interlocking one or more fibers 304 directly onto the implantable medical device 104 while the implantable medical device 104 is at a reduced diameter. A prior restraining mechanism applied to the implantable medical device 104 at a reduced diameter after formation may expand the implantable medical device while the prior restraining mechanism is disposed around the implantable medical device. By interlocking one or more fibers 304 directly onto the implantable medical device 104, the chance of expansion from the reduced diameter is minimized. The braider 300 and funnel 200 capture and restrain the implantable medical device 104 in its reduced diameter state. In certain instances, the device can exit the funnel 200 at an intermediate diameter, and the application of one or more fibers 304 can reduce the diameter to the target profile.

[0049] In certain examples, interlocking one or more fibers 304 along the length of the implantable medical device 104 includes forming a knot by braiding one or more fibers 304 (e.g., as shown in FIG. 4). In other examples, interlocking one or more fibers 304 along the length of the implantable medical device 104 includes braiding one or more fibers 304 to form the restraining mechanism 102 (e.g., as shown in FIG. 5). The needle (or fiber applicator) 306 can be automatically actuated to create a desired pattern for the restraining mechanism 102. The needle 306 can be moved axially and / or rotated around the implantable medical device 104 to create circumferentially offset knots, seams or braids, or the needle 306 can be maintained in a single position to create aligned knots, seams or braids (e.g., as shown in FIG. 4).

[0050] Additionally, the braider can interlock one or more fibers 304 in two directions. For example, the braider can interlock one or more fibers 304 in a first direction 308 to form a first layer of the restraining mechanism 102. The implantable medical device 104 can be forced from the funnel 200 into the braider in the first direction 308 to form the first layer of the restraining mechanism 102 (as shown in FIGS. 3A and 3B ). Additionally, the one or more fibers 304 can be wrapped circumferentially around the implantable medical device 104 after or while the one or more fibers 304 are interlocked. The braider 300 can interlock one or more fibers 304 in a second direction 310 to form a second layer of the restraining mechanism 102. To form the second layer of the restraining mechanism 102, the implantable medical device 104 or the braider 300 is moved in the second direction 310.

[0051] In certain instances, one or more fibers 304 can be interlocked together while tensioning the fibers 304. The braider 300 can mechanically hold the one or more fibers 304 in tension during interlocking.

[0052] After the restraining mechanism 102 is formed, the implantable medical device 104 is maintained at a reduced diameter for delivery as described above. Deployment of the implantable medical device 104 is accomplished by pulling on the ends of one or more of the fibers 304 (as shown above with reference to FIG. 1) to release or unweave the restraining mechanism 102.

[0053] FIG. 4 is an exemplary single fiber restraining mechanism according to some embodiments. The restraining mechanism 102 may comprise a portion of a delivery system (e.g., a catheter and an expandable medical device as shown in FIG. 1). FIG. 4 illustrates the restraining mechanism 102 in a restrained configuration in which an expandable medical device (not shown) is held at a diameter smaller than a deployed, expanded, or actuated diameter. The restraining mechanism 102 is configured to restrain the expandable medical device in the delivery configuration. Additionally, the restraining mechanism 102 includes a single fiber 106 arranged with a plurality of knots 408 to maintain the restraining mechanism 102 in the restrained configuration. The plurality of knots 408 are constructed and arranged such that at least two of the plurality of knots 408 are in contact in the restrained configuration.

[0054] In certain instances, the single fiber 106 forms a plurality of loops 410 circumferentially disposed about the expandable medical device. Further, as shown in FIG. 4, the plurality of loops 410 are densely packed such that at least two of the plurality of loops 410 are in physical contact. The loops 410 are unknotted portions of the single fiber 102 between the knots of the plurality of knots 408.

[0055] The restraining mechanism 102 is disposed along the length of the expandable medical device. The restraining mechanism 102 can also be disposed circumferentially around the expandable medical device to substantially cover the expandable medical device 104 for delivery. A single fiber 106 can be disposed within a lumen of the catheter (not shown) and extend toward a proximal end of the catheter 100 that is disposed outside the patient during delivery of the expandable medical device. The one or more fibers 106 include a proximal end 108 to which a user can apply tension to release the restraining mechanism 102 and deploy the expandable medical device.

[0056] 5 is an exemplary multi-fiber restraining feature 102 according to some embodiments. The multi-fiber restraining feature 102 can be formed by interlocking multiple fibers together as discussed above with reference to Figures 2-3. Starting with two fibers, any desired and appropriate number of fibers can be combined in this manner, and the multi-fiber restraining feature 102 is formed by interlocking the fibers together.

[0057] The restraining mechanism 102 is disposed along the length of the expandable medical device 104. The restraining mechanism 102 can also be disposed circumferentially around the expandable medical device 104 to substantially cover the expandable medical device 104 for delivery. A single fiber 106 can be disposed within a lumen of the catheter (not shown) and extend toward a proximal end of the catheter 100 that is disposed outside the patient during delivery of the expandable medical device 104. The one or more fibers 106 include a proximal end 108 to which a user can apply tension to release the restraining mechanism 102 and deploy the expandable medical device 104.

[0058] The materials used to make one or more fibers of the present invention are similarly open to modification and customization for a given application. For most applications discussed herein, the one or more fibers used to form the restraining mechanism 102 can include thermoplastic threads such as polytetrafluoroethylene (PTFE), expanded PTFE, silk, polypropylene, polyamide (nylon), various plastic or metal materials (e.g., stainless steel or nickel-titanium (nitinol) alloys), and bioabsorbable materials such as PLA or PGA. Particularly preferred for use in coverings of implantable medical devices are polytetrafluoroethylene (PTFE) threads, particularly expanded PTFE threads, such as threads available under the trademark RASTEX® from WL Gore & Associates, Inc. of Elkton, Md., or sutures available under the trademark GORE-TEX® from WL Gore & Associates, Inc. of Flagstaff, Ariz.

[0059] 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) 1. A method of forming a restraining mechanism for implantable medical device delivery, comprising: reducing a diameter of the implantable medical device from a deployed diameter to a reduced diameter; and circumferentially wrapping one or more fibers around the implantable medical device; and interlocking the one or more fibers along a length of the implantable medical device while the implantable medical device is at the reduced diameter to form a restraining mechanism; A method comprising: (Aspect 2) The method of embodiment 1, wherein interlocking the one or more fibers along the length of the implantable medical device comprises braiding the one or more fibers to form a restraining mechanism. (Aspect 3) The method of any one of embodiments 1-2, wherein interlocking the one or more fibers along a length of the implantable medical device comprises forming a knot by braiding the one or more fibers. (Aspect 4) 4. The method of any one of embodiments 1-3, wherein interlocking the one or more fibers comprises knitting the one or more fibers together while the one or more fibers are in direct contact with the implantable medical device. (Aspect 5) The method of any one of embodiments 1-4, wherein reducing the diameter of the implantable medical device comprises forcing the implantable medical device through a funnel having an inner surface of a reducing diameter. (Aspect 6) The method of embodiment 5, wherein interlocking the one or more fibers comprises positioning the one or more fibers along the implantable medical device as it exits the funnel at a reduced diameter. (Aspect 7) The method of any one of embodiments 5-6, wherein the funnel comprises an inner surface that reduces an inner diameter of the funnel and a braided zone having a length approximately equal to a length of the implantable medical device. (Aspect 8) The method of any one of aspects 5-7, further comprising disposing one or more fibers around an exterior surface of the funnel and dragging the one or more fibers along the exterior surface of the funnel toward an end of the funnel, wherein the implantable medical device exits the funnel at a reduced diameter and engages the implantable medical device. (Aspect 9) The method of any one of embodiments 1-7, wherein interlocking the one or more fibers comprises interlocking in a first direction along a length of the implantable medical device to form a first layer of a restraining feature, and further interlocking the one or more fibers back over the first layer in a second direction along the length of the implantable medical device to form a second layer of a restraining feature. (Aspect 10)

[0023] The method of any one of the preceding embodiments, wherein interlocking the one or more fibers comprises braiding the one or more fibers together using a braider. (Aspect 11) 10. The method of claim 9, wherein the braider comprises one or more needles, the one or more needles being equal to the one or more fibers, and interlocking the one or more fibers comprises braiding the one or more fibers together with the one or more needles. (Aspect 12) 1. A system for forming a restraining mechanism for implantable medical device delivery, comprising: The system comprises: a funnel configured to reduce a diameter of the implantable medical device from a deployed diameter to a reduced diameter; and a braider configured to interlock one or more fibers along a length of the implantable medical device to form a restraining mechanism while the implantable medical device is at the reduced diameter; Including, the system. (Aspect 13) 13. The system of embodiment 12, wherein the funnel comprises an inner surface that reduces an inner diameter of the funnel and a braided zone having a length approximately equal to a length of the implantable medical device. (Aspect 14) 14. The system of any one of aspects 12-13, wherein the braider comprises one or more needles, the one or more needles equal to one or more fibers, and interlocking the one or more fibers comprises braiding the one or more fibers together by the one or more needles. (Aspect 15) 15. The system of any one of aspects 12-14, wherein the funnel is configured to facilitate placement of the one or more fibers on the implantable medical device to interlock the one or more fibers. (Aspect 16) loading an implantable medical device into a funnel having an inner surface and a braided zone that reduces an inner diameter of the funnel; reducing a diameter of the implantable medical device by forcing the implantable medical device through an inner surface of the funnel that reduces the inner diameter of the funnel; and applying one or more fibers to the implantable medical device as it exits the braided zone of the funnel to maintain the implantable medical device at a reduced diameter; A method comprising: (Aspect 17) 17. The method of embodiment 16, wherein applying the one or more fibers comprises tying single fibers together to form a restraining feature. (Aspect 18) 17. The method of embodiment 16, wherein applying the one or more fibers comprises braiding two or more fibers together to form a restraining mechanism. (Aspect 19) The method of embodiment 16, further comprising placing one or more fibers around an outer surface of the funnel and dragging the one or more fibers along the outer surface of the funnel toward an end of the funnel, where the implantable medical device exits the funnel with a reduced diameter, engaging the implantable medical device. (Aspect 20) The method of embodiment 16, wherein applying the one or more fibers comprises interlocking the one or more fibers in a first direction along a length of the implantable medical device to form a first layer of a restraining mechanism, and further comprises interlocking the one or more fibers back over the first layer in a second direction along the length of the implantable medical device to form a second layer of a restraining mechanism.

Claims

1. 1. A system for forming a restraining mechanism for an implantable medical device, comprising: The system comprises: a funnel configured to reduce a diameter of the implantable medical device from a deployed diameter to a reduced diameter; and a braider configured to braid along a length of the implantable medical device while the implantable medical device is at the reduced diameter to interlock one or more fibers to form a restraining mechanism; Including, the funnel includes an outer surface and an inner surface, the inner surface reducing an inner diameter of the funnel, the inner surface including a taper, and the outer surface including an inflection point where the outer surface transitions from a first taper to a second taper; the one or more fibers are wrapped circumferentially around the implantable medical device and the funnel; The system, wherein the funnel includes a braiding zone in which the one or more fibers are braided.

2. The system of claim 1 , wherein the funnel includes a braided zone having a length approximately equal to a length of the implantable medical device.

3. 3. The system of claim 1, wherein the braider comprises one or more needles, a number of the one or more needles being equal to a number of the one or more fibers, and interlocking the one or more fibers comprises braiding the one or more fibers with the one or more needles.

4. The system of any one of claims 1 to 3, wherein the funnel is configured to facilitate placement of the one or more fibers on the implantable medical device to interlock the one or more fibers.

5. The system of any one of claims 1 to 4, wherein the funnel defines an exit point for the implantable medical device, and the braided zone is defined at the exit point.

6. The system of any one of claims 1 to 4, wherein the funnel includes an extension that is the braided zone.

7. The system of any one of claims 1 to 6, wherein the inner surface is tapered.

8. The system of claim 7 , wherein the funnel includes an outer surface that is tapered.

9. The system of claim 8 , wherein the exterior surface of the funnel includes an inflection point such that the exterior surface transitions from a greater taper to a lesser taper.

10. The system of any one of claims 1 to 9, wherein the braiding zone is a landing point for the one or more fibers.

11. The system of claim 1 , wherein the braided zone has a length that is between 20% and 150% of a length of the implantable medical device.

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