Constraining systems and associated methods

Abstract

To provide an excellent system to deliver an implantable medical device.SOLUTION: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that may include an implantable medical device and a removable constraint 102. The removable constraint may be arranged about and configured to releasably constrain the implantable medical device with the removable constraint including at least two interlocking strands 110, 112 having different strand properties.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 62 / 741,937, filed October 5, 2018, and also claims the benefit of Provisional Application No. 62 / 737,040, filed September 26, 2018, both of which are incorporated herein by reference in their entireties for all purposes.

[0002] Field FIELD OF THE DISCLOSURE The present disclosure relates generally to apparatus, systems and methods including a cover for use in the delivery of an implantable medical device, and more particularly, to apparatus, systems and methods including a cover for constraining an expandable implantable medical device during delivery of the device. [Background technology]

[0003] background Stents and stent grafts can be utilized to provide radial support to a variety of tubular passageways within the body, including arteries, veins, airways, gastrointestinal tracts, and biliary tracts. The preferred method for placing these devices uses specialized delivery systems to precisely position and deploy the device at the treatment site. 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 vascular systems, protection of constrained devices, and ability to precisely position and deploy the device.

[0004] The stent or stent graft may be deployed and plastically deformed by using an inflatable balloon (e.g., a balloon-expandable stent) or to self-expand and elastically recover from a collapsed or constrained delivery diameter to an expanded and deployed diameter (e.g., a self-expandable stent).

[0005] 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. Summary of the Invention

[0006] Abstract In one example ("Example 1"), a delivery system includes an implantable medical device and a removable restraint configured to be positioned around and releasably restrain the implantable medical device, the removable restraint including at least two interlocking strands including a first interlocking strand having different strand characteristics than a second interlocking strand, the first interlocking strand including a deployment line configured to release the removable restraint in response to a force applied to the deployment line.

[0007] In another example ("Example 2"), further to the delivery system of Example 1, the ratio of the delivery diameter of the implantable medical device to the deployed diameter is less than 0.3.

[0008] In another example ("Example 3"), in addition to the delivery system of any one of Examples 1-2, the different strand characteristics include strand thickness.

[0009] In another example ("Example 4"), in addition to the delivery system of any one of Examples 1-2, the different strand properties include strand denier.

[0010] In another example ("Example 5"), in addition to the delivery system of any one of Examples 1-2, the different strand property includes a strand coefficient of friction.

[0011] In another example ("Example 6"), in addition to the delivery system of any one of Examples 1-2, the different strand properties include strand material.

[0012] In another example ("Example 7"), in addition to the delivery system of any one of Examples 1-2, the different strand properties include strand stiffness.

[0013] In another example ("Example 8"), further to the delivery system of any one of Examples 1-7, the implantable medical device has a radial force at a delivery diameter of the implantable medical device, the two interlocking strands are adapted to be detached by a knit force applied to the deployment line, and the ratio of the radial force to the knit force is about 100 to about 500.

[0014] In another example ("Example 9"), further to the delivery system of Example 8, the ratio of the radial force to the knit force is from about 170 to about 475.

[0015] In another example ("Example 10"), further to the delivery system of Example 8, the ratio of the radial force to the knit force is from about 225 to about 450.

[0016] In another example ("Example 11"), further to the delivery system of Example 8, the ratio of the radial force to the knit force is from about 200 to about 425.

[0017] In another example ("Example 12"), a delivery system includes an implantable medical device and a removable restraint configured to be positioned around and releasably restrain the implantable medical device, the removable restraint including at least two interlocking strands, the at least two interlocking strands including a first interlocking strand and a second interlocking strand, the first interlocking strand and the second interlocking strand differ from each other in at least one strand characteristic.

[0018] In another example ("Example 13"), further to the delivery system of Example 12, the first interlocking strand has a different strand characteristic than the second of the at least two interlocking strands.

[0019] In another example ("Example 14"), in addition to the delivery system of any one of Examples 12-13, the first interlocking strand is a deployment line configured to release the removable restraint in response to a force applied to the deployment line.

[0020] In another example ("Example 15"), an expandable medical device includes an implantable medical device having a delivery diameter, a deployment diameter, and a radial force at the delivery diameter; a removable constraint attached to the implantable medical device at the delivery diameter, the removable constraint including a plurality of interlocking strands in a warp knit form, the removable constraint configured to be remotely released when a deployment force is applied to a deployment line, the plurality of interlocking strands including a first strand and a second strand, the first strand and the second strand differ from one another in at least one strand property, and a ratio of the radial force to the deployment force is from about 150 to about 500.

[0021] In another example ("Example 16"), in addition to the delivery system of Example 15, the different strand properties include at least one of strand thickness, strand denier, strand coefficient of friction, strand material, and strand stiffness.

[0022] In another example ("Example 17"), in addition to the delivery system of Example 16, the different strand characteristic is a strand thickness, where the difference between the cross-sectional diameter of the first strand and the cross-sectional diameter of the second strand is about 0.0025 square inches.

[0023] In another example ("Example 18"), in addition to the delivery system of Example 16, the different strand characteristic is strand thickness, and the strand thickness of the first strand and the second strand differs by about 0.0005 inches to about 0.008 inches.

[0024] In another example ("Example 19"), further to the delivery system of any one of Examples 15-18, the ratio of the delivery diameter of the implantable medical device to the deployed diameter is about 0.3.

[0025] In another example ("Example 20"), further to the delivery system of any one of Examples 15-19, the ratio of the radial force to the knit force is less than about 450. [Brief description of the drawings]

[0026] 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.

[0027] [Figure 1] FIG. 1 is a top view of a delivery system including a catheter with a removable restraint, according to an embodiment.

[0028] [Diagram 2] FIG. 2 is a side view of an implantable medical device including a removable constraint, according to an embodiment.

[0029] [Diagram 3] FIG. 3 is a schematic diagram of an interlocking strand, according to an embodiment.

[0030] [Figure 4] FIG. 4 is an end view of a removable restraint showing an exemplary knot row, according to an embodiment.

[0031] [Diagram 5] FIG. 5 is an end view of a removable restraint showing an exemplary knot row, according to an embodiment.

[0032] [Figure 6] 6A-6B are images of a delivery system in a delivery configuration and a semi-deployed configuration, respectively, according to an embodiment.

[0033] [Figure 7] FIG. 7 is a graph comparing knitting forces for deployment of implantable medical devices. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] As used herein in relation to ranges of measurements, "about" and "approximately" are used interchangeably to refer to measurements that include the stated measurements and can include measurements that are reasonably close to the stated measurements, but can differ by a reasonably small amount as understood and readily ascertained by one of ordinary skill in the art that may result from measurement errors, differences in calibration of measuring and / or manufacturing equipment, human errors in reading and / or setting measurements, adjustments made to optimize performance and / or structural parameters given differences in measurements relative to other components, specific implementation scenarios, imprecise adjustment and / or manipulation of objects by humans or machines, etc.

[0035] The foregoing examples are exemplary only and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by this disclosure. While multiple 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 are to be regarded as illustrative in nature and not as restrictive.

[0036] Detailed Description 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.

[0037] 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.

[0038] 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 woven, sewn or interlocked to form the restraining mechanism. Thus, one or more fibers are woven, sewn or interlocked together around or around the implantable medical device. As described above, the implantable medical device is contracted, collapsed or restrained to a contracted (delivery) diameter 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 contracted diameter).

[0039] Figure 1 is a top view of a delivery system 10 including a catheter 100 with a removable restraint 102, according to some embodiments. As shown in Figure 1, the removable restraint 102 is configured to restrain an implantable medical device 104 in a delivery configuration. The removable restraint 102 can include one or more fibers 106 disposed about the device 104 to maintain the removable restraint 102 in the restrained configuration.

[0040] The removable restraint 102 is disposed along the length of the device 104. The removable restraint 102 may also be disposed circumferentially around the device 104 to substantially cover the device 104 for delivery. The one or more fibers 106 may 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 the patient during delivery of the device 104. The one or more fibers 106 include a proximal end 108 to which a user may apply tension to release the removable restraint 102 and deploy the device 104.

[0041] In certain instances, the one or more fibers 106 release similar to a ripcord such that interlocking portions (e.g., overlapping fibers or knots) are released sequentially along the length of the device 104. As described in more detail below, a removable restraint 102 is formed by interlocking one or more fibers 106 directly on the device 104. The device 104 can be a stent, stent graft, balloon, or similar device.

[0042] 2 is a side view of a device 104 including a removable restraint 102, according to an embodiment. As shown, the device 104 includes a delivery diameter D1 and a deployed diameter D2 (not shown) that is larger than the delivery diameter D1. The removable restraint 102 is disposed about the device 104 at the delivery diameter D1. As shown, the removable restraint 102 includes at least two interlocking strands in the form of a warp knit. For example, the removable restraint 102 can include a first interlocking strand 110 and a second interlocking strand 112. The first interlocking strand 110, 112 can act as, for example, a deployment line 120 that is configured to release the removable restraint 102 and release the device 104 from the delivery diameter D1 to the deployed diameter D2 in response to a knitting force applied to the deployment line 120.

[0043] The device 104 can have a desired deployed diameter D2, for example, between about 5 mm and 15 mm, or between 6 mm and 9 mm, or between 6 mm and 12 mm, and a delivery diameter D1 that is smaller than the deployed diameter D2. For example, in some instances, the ratio of the delivery diameter D1 of the device 104 to the deployed diameter D2 (not shown) of the device 104 is less than about 0.3, less than about 0.29, less than about 0.28, less than about 0.27, or less than about 0.26.

[0044] In some examples, the first interlocking strands 110 have at least one strand characteristic that is different from the second interlocking strands 112, which can affect the amount of knitting force required to release the removable restraint 102. Examples of different strand characteristics include strand thickness, strand denier, strand coefficient of friction, strand material, and / or strand stiffness.

[0045] For example, the first interlocking strand 110 can have a first diameter or thickness and the second interlocking strand 112 can have a second diameter or thickness that is greater than the first diameter. In various examples, using a larger diameter or thickness for the second interlocking strand 112 helps to increase friction between the first and second interlocking strands 110, 112, which in turn helps to maintain the device 104 in the delivery configuration. In some examples where the different strand characteristic is strand diameter or thickness, the first and second interlocking strands 110, 112 can have cross-sectional diameters or thicknesses that vary by about 0.0015 cm (0.0006 inches). In other examples, the cross-sectional diameter may vary from about 0.0008 cm, 0.0009 cm, 0.0010 cm, 0.0011 cm, 0.0012 cm, 0.0013 cm, 0.0014 cm, 0.0015 cm, 0.0016 cm, 0.0017 cm, 0.0018 cm, 0.0019 cm, 0.0020 cm, 0.0021 cm, 0.0022 cm, or any value therebetween. Additionally, the difference in diameter between the first interlocking strands 110, 122 and the second interlocking strands 110, 122 may be from about 0.0005 inches to about 0.008 inches. For reference, the term "diameter" is not intended to require a circular cross-section, but instead should be understood broadly to refer to the maximum cross-sectional dimension or effective diameter of the strands.

[0046] For reference, the term "diameter" is not intended to require a circular cross-section, but instead should be understood broadly to refer to the maximum cross-sectional dimension of the strand.

[0047] In various examples, the first interlocking strands 110 can include a first material and the second interlocking strands 112 can include a second material that is different from the first material (e.g., as an alternative or additional feature to different diameters between the strands). The first interlocking strands 110 can, in certain cases, include a material that has a different (e.g., higher or lower) tensile strength compared to the tensile strength of the material of the second interlocking strands 112. Additionally or alternatively, the first interlocking strands 110 can include a material that has a different (e.g., higher or lower) surface roughness compared to the surface roughness of the material of the second interlocking strands 112. Furthermore, the first interlocking strands 110 can include a material that has a different (e.g., higher or lower) adhesion or stickiness to other materials compared to the adhesion or stickiness of the material of the second interlocking strands 112. In various examples, the first and second strands 110, 112 exhibit different static and / or kinetic coefficients of friction, with the second strand 112, for example, exhibiting a relatively higher static and / or kinetic coefficient of friction than the first strand 110. From the above, it should be understood that the strands 110, 112 can include a number of different properties. For example, the first interlocking strand 110 can have a different (e.g., higher or lower) tensile strength and a different (e.g., higher or lower) surface roughness as compared to the second interlocking strand 112.

[0048] Potential materials for the strands 110, 112 discussed herein include, for example, fluoropolymers such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, perfluoroelastomers, polytetrafluoroethylene, silicone, urethane, ultra-high molecular weight polyethylene, aramid fibers, and combinations thereof. Other embodiments for the strands 110, 112 can include high strength polymer fibers such as ultra-high molecular weight polyethylene fibers (e.g., Spetra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). In general, any of the above-mentioned properties can be evaluated using ASTM or other recognized measurement techniques and standards, as will be appreciated by those skilled in the art.

[0049] In certain instances, the first and second interlocking strands 110, 112 can comprise the same material, but in other aspects can be different. For example, one of the strands can comprise a filler or core material, can be surface treated by etching, deposition or crown or other plasma treatment, among others, including being coated with a suitable coating material. Using different strand materials for the strands 110, 112, as well as different diameters, can increase friction between the first and second interlocking strands 110, 112, helping to maintain the device 104 in the delivery configuration.

[0050] The device 104 has a radial force at the delivery diameter D1. The radial force generally refers to a force caused by the device 104 acting against the removable restraint 102 at any point during the deployment of the device 104. As described above, the interlocking strands 110, 112 are adapted to be detached upon application of a deployment force to the deployment line 120. In some examples, the ratio of this radial force of the device 104 to the knitting force applied to the deployment line 120 is less than about 500. In other examples, the ratio of this radial force of the device 104 to the knitting force applied to the deployment line 120 is less than about 475. Furthermore, the ratio of this radial force of the device 104 to the knitting force applied to the deployment line 120 can be less than about 450. Furthermore, the ratio of this radial force of the device 104 to the knitting force applied to the deployment line 120 is less than about 425 in other examples. Further, the ratio of radial force to knit force can be, for example, from about 10, 20, 30, 40, 50, 100, 200, 300, 400 (or any number in between) to about 500, from about 10, 20, 30, 40, 50, 100, 200, 300, 400 (or any number in between) to about 475, from about 10, 20, 30, 40, 50, 100, 200, 300, 400 (or any number in between) to about 450, or from about 10, 20, 30, 40, 50, 100, 200, 300, 400 (or any number in between) to 425.

[0051] 3 is a schematic diagram of the interlocking strands of the removable restraint 102 (FIGS. 1-2), according to an embodiment. The interlocking strands (e.g., as shown, first and second interlocking strands 110, 112) are generally interwoven with one another to form at least one knot row 114. As shown, the knot row 114 is formed from interlocking loops formed from the first and second interlocking strands 110, 112. For example, a first interlocking loop 116 is formed from the first interlocking strand 110 and interwoven with a second interlocking loop 118 formed from the second interlocking strand 112. This interlocked loop configuration allows for release of the removable restraint 102 (FIGS. 1-2) by applying a deployment force to the deployment line 120 (releasing the knitting force).

[0052] In general, the knot rows 114 may be located at any location around the circumference of the removable restraint 102. In certain instances, the interlocking strands may form more than one knot row. FIG. 4 is an end view of the removable restraint 102 illustrating an exemplary knot row 114, according to an embodiment. As shown, the first and second interlocking strands 110, 112 may form a first and second knot row 122, 124 that are located at different locations around the circumference of the removable restraint 102. For example, the knot rows may be spaced approximately 180 degrees apart from one another, approximately 90 degrees apart from one another, approximately 60 degrees apart from one another, or any other distance as desired.

[0053] 5 is an end view of the removable restraint 102 showing an exemplary knot row 114, according to an embodiment. As shown, in some examples, the removable restraint 102 can include more than two interlocking strands. For example, the removable restraint 102 can include, for example, a first interlocking strand 130, a second interlocking strand 132, a third interlocking strand 134, and a fourth interlocking strand 136. In these examples, the removable restraint 102 can also include a first knot row 140, a second knot row 142, a third knot row 144, and a fourth knot row 146 corresponding to the first interlocking strand 130-136, respectively. Applying a force to one of the first interlocking strand 130-136 can initiate the unraveling of the corresponding knot row, thus allowing for selective deployment of various portions of the removable restraint 102.

[0054] In some instances, at least one of the interlocking strands can have a different strand characteristic than the remaining interlocking strands. For example, the first, second and third strands 130, 132, 134 can have the same strand characteristic while the fourth strand 136 has a different strand characteristic. In other instances, two of the interlocking strands can have one strand characteristic while the remaining strands have a second strand characteristic that is different from the first strand characteristic, etc. In some instances, each of the interlocking strands can have different strand characteristics to facilitate selective deployment of various portions of the removable restraint 102, as desired. In certain instances, one of the interlocking strands 130, 132, 134, 136 has a different characteristic than an adjacent one of the interlocking strands 130, 132, 134, 136.

[0055] As noted above, the knot rows can be placed anywhere around the circumference of the removable restraint 102. Although Figure 5 shows the knot rows spaced approximately 90 degrees apart from one another, the knot rows can be spaced any amount apart as desired. For example, the knot rows can be spaced 60 degrees apart from one another, 45 degrees apart from one another, or less than that to achieve a desired deployed length ratio.

[0056] In some instances, having interlocking strands with different properties can reduce the tilt of device 104 before it is released. For example, the interlocking strands can reduce the tilt (deployment angle) of device 104 before the knots of knot row 114 are sequentially released. The tilt of device 104 can lead to an advanced or pre-deployment of device 104 before the intended deployment.

[0057] 6A-6B are images of a delivery system in a delivery configuration and a semi-deployed configuration, respectively, according to an embodiment. As shown in FIG. 6A, a removable restraint 102 is attached to the device 104 at its delivery diameter D1. During deployment, a knitting force is applied to the deployment line 120 to release the removable restraint 102 by undoing the knot row 114, as shown in FIG. 5B. Once the removable restraint 102 is released, the device 104 is released to a deployed diameter D2.

[0058] Interlocking strands 110, 112 having different properties can reduce the tilt of device 104 before being released. For example, interlocking strands 110, 112 can reduce the tilt (or deployment angle) of device 104 before the knots of knot train 114 are sequentially released. Device 104 begins to expand to a larger diameter after release of restraining mechanism 102. Device 104 can have an angle A between the portion held by restraining mechanism 102 and the portion that has expanded or is beginning to expand. Due to angle A and device 104 expending force to deploy to deployed diameter D2, the previous restraint can shift due to the tilt or expansion of portions of device 104. However, different strand properties can reduce the tilt of device 104 by maintaining the position of each knot relative to device 104 as the knots are sequentially released, reducing unwanted deployment (e.g., accelerated deployment or pre-deployment) of device 104, as described in detail above.

[0059] FIG. 7 is a graph comparing knit forces for deployment of implantable medical devices as discussed herein. Knit force is the force applied to the deployment line to remove the knit loop from within the enclosing knit loop and to remove accelerated deployment. As shown in FIG. 7, as knit force increases, accelerated deployment (AD) decreases. Described herein is a method to achieve increased knit force. This is evident when the constrained diameter / expanded diameter ratio is less than 0.3 or for larger nominal diameter devices (9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, and larger, including 25mm, 30mm, 40mm, and 50mm).

[0060] The invention of the present 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 as long as they come within the scope of the appended claims and their equivalents.

Claims

1. Implantable medical devices, and a removable restraint configured to be disposed about and releasably restrain said implantable medical device; A delivery system comprising: A delivery system, wherein the removable restraint includes at least two interlocking strands including a first interlocking strand having different strand characteristics than a second interlocking strand, the first interlocking strand including a deployment line configured to release the removable restraint in response to a force applied to the deployment line.

2. 10. The delivery system of claim 1, wherein the ratio of the delivery diameter to the deployed diameter of the implantable medical device is less than 0.

3.

3. The delivery system of any one of claims 1 to 2, wherein the different strand characteristics include strand thickness.

4. The delivery system of any one of claims 1 to 2, wherein the different strand properties include strand denier.

5. The delivery system of any one of claims 1 to 2, wherein the different strand properties include strand coefficient of friction.

6. The delivery system of any one of claims 1 to 2, wherein the different strand properties include strand material.

7. The delivery system of claim 1 , wherein the different strand properties include strand stiffness.

8. 8. The delivery system of claim 1, wherein the implantable medical device has a radial force at a delivery diameter of the implantable medical device, the at least two interlocking strands are adapted to be detached by a knitting force applied to the deployment line, and the ratio of the radial force to the knitting force is from about 100 to about 500.

9. The delivery system of claim 8 , wherein the ratio of said radial force to said knit force is from about 170 to about 475.

10. The delivery system of claim 8 , wherein the ratio of said radial force to said knit force is from about 225 to about 450.

11. The delivery system of claim 8 , wherein the ratio of said radial force to said knit force is from about 200 to about 425.

12. Implantable medical devices, and a removable restraint configured to be disposed about and releasably restrain said implantable medical device; A delivery system comprising: A delivery system, wherein the removable restraint comprises at least two interlocking strands, the at least two interlocking strands comprising a first interlocking strand and a second interlocking strand, the first interlocking strand and the second interlocking strand differing from each other in at least one strand characteristic.

13. The delivery system of claim 12 , wherein the first interlocking strand has a different strand characteristic than a second of the at least two interlocking strands.

14. The delivery system of any one of claims 12 to 13, wherein the first interlocking strand is a deployment line configured to release the removable restraint in response to a force applied to the deployment line.

15. an implantable medical device having a delivery diameter, a deployment diameter, and a radial force at the delivery diameter; a removable constraint attached to said implantable medical device at its delivery diameter; 1. An expandable medical device comprising: the removable restraint includes a plurality of interlocking strands in a warp knit configuration, the removable restraint configured to be remotely released when a deployment force is applied to a deployment line; the plurality of interlocking strands includes first strands and second strands, the first strands and the second strands differing from one another in at least one strand characteristic; The ratio of said radial force to said deployment force is from about 150 to about 500.

16. 16. The expandable medical device of claim 15, wherein the different strand properties include at least one of strand thickness, strand denier, strand coefficient of friction, strand material, and strand stiffness.

17. 17. The expandable medical device of claim 16, wherein the different strand characteristic is strand thickness, where the difference between the cross-sectional diameter of the first strand and the cross-sectional diameter of the second strand is about 0.0025 square inches.

18. 17. The expandable medical device of claim 16, wherein the different strand characteristic is a strand thickness, and the strand thickness of the first strand and the second strand differs by about 0.0005 inches to about 0.008 inches.

19. The expandable medical device of any one of claims 15 to 18, wherein the ratio of the delivery diameter of the implantable medical device to the deployed diameter is about 0.

3.

20. The expandable medical device of any one of claims 15-19, wherein the radial force to knit force ratio is less than about 450.

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