Constraint mechanism for selective deployment and associated methods

Abstract

Aspects of the present disclosure relate to medical device deployment apparatuses, systems, and methods. The apparatus, system, and method can include at least one first restraint fiber and at least one second restraint fiber. The at least one first restraint fiber is arranged as a series of multiple loops so as to form a warp knitted fabric around a medical device in a constrained configuration. The at least one second restraint fiber is arranged together with the at least one first restraint fiber and has at least one loop arranged in a non-warp knitted pattern.

Description

Technical Field

[0001] The present disclosure relates to devices, systems, and methods that include restraints for the delivery of implantable medical devices. More specifically, the present disclosure relates to devices, systems, and methods that include restraints for the selective deployment of expandable devices during device delivery. Background Art

[0002] Stents and stent grafts or other implantable medical devices can be used to radially support various tubular passageways within the body, including arteries, veins, airways, the gastrointestinal tract, and the biliary tract. The preferred method of placing these devices is to use a dedicated delivery system to precisely place and deploy the device at the site to be treated. These delivery systems allow practitioners to minimize the trauma and technical difficulty associated with device placement. Attributes of the delivery system include: low profile; the ability to introduce a sheath; the ability to pass smoothly and atraumatically through tortuous vasculature; protection of the constrained device; and the ability to precisely position and deploy the device.

[0003] A stent or stent graft can be deployed and plastically deformed, for example, by using an inflatable balloon or self-expansion, such as by elastically returning from a collapsed or constrained delivery diameter to an expanded and deployed diameter. Some stents are designed to elastically return by being made of a material having elastic return properties at their functional diameter and then being radially compressed for mounting on a delivery catheter.

[0004] These stent and stent graft devices can be held, compressed, or constrained in a delivery configuration before and during delivery to a target location. Summary of the Invention

[0005] According to one example (“Example 1”), a medical device deployment apparatus includes at least one first restraint fiber arranged as a series of multiple loops to form a knitted fabric around a medical device in a constrained configuration, the knitted fabric configured to separate and be removed to deploy the medical device; and at least one second restraint fiber arranged with the at least one first restraint fiber, the at least one second restraint fiber having at least one loop arranged in a non-knitted fabric pattern.

[0006] According to yet another example (“Example 2”) further to the apparatus of Example 1, the at least one first restraint fiber includes multiple fibers woven together.

[0007] According to yet another example (“Example 3”) further to the apparatus of any of Examples 1-2, the first restraint fiber and the at least one second restraint fiber form a restraint, and at least one loop arranged in a non-woven fabric pattern is arranged at a distal end of the restraint.

[0008] According to yet another example for the device of Example 3 (“Example 4”), at least one loop arranged in a non-woven fabric pattern is arranged in a chain stitch.

[0009] According to yet another example for the device of Example 4 (“Example 5”), at least one first restraint fiber is intertwined with at least one second restraint fiber to form a restraint member, wherein each of the at least one first restraint fiber and the at least one second restraint fiber forms a row of knots (knots in a row).

[0010] According to yet another example for the device of Example 5 (“Example 6”), the first row of the row of knots is formed by at least one first restraint fiber in a woven fabric pattern, and the second row of the row of knots is formed by at least one second restraint fiber in a non-woven fabric pattern.

[0011] According to yet another example for the device of Example 6 (“Example 7”), the non-woven fabric pattern of the second row includes a chain stitch.

[0012] According to yet another example for the device of any one of Examples 1-6 (“Example 8”), at least one first restraint fiber includes a first restraint fiber and a third restraint fiber, and at least one second restraint fiber includes a second restraint fiber and a fourth restraint fiber, wherein the first restraint fiber, the second restraint fiber, the third restraint fiber, and the fourth restraint fiber are intertwined to form a restraint member.

[0013] According to yet another example for the device of Example 8 (“Example 9”), the restraint member includes a plurality of rows of knots, the plurality of rows of knots including a first row of knots formed by the intertwining of the first restraint fiber and the second restraint fiber, a second row of knots formed by the intertwining of the second restraint fiber and the third restraint fiber, a third row of knots formed by the intertwining of the third restraint fiber and the fourth restraint fiber, and a fourth row of knots formed by the intertwining of the fourth restraint fiber and the first restraint fiber.

[0014] According to yet another example for the device of Example 9 (“Example 10”), at least one of the plurality of knots forms a woven fabric around a medical device in a constrained configuration, and another of the plurality of knots forms a non-woven fabric around the medical device in a constrained configuration.

[0015] According to yet another example for the device of any one of Examples 1-10 (“Example 11”), at least one first restraint fiber and at least one second restraint fiber combine to form a deployment line.

[0016] According to another example, further to the device for any one of Examples 1-11 (“Example 12”), the braided fabric is configured to separate and be removed to deploy the medical device, and the braided fabric is arranged with a non-braided fabric pattern that interrupts the braided fabric.

[0017] According to one example (“Example 13”), a method of deploying a constrained medical device includes arranging the medical device in a restraint that includes at least one first restraint fiber arranged as a series of a plurality of loops to form a braided fabric around the medical device in a constrained configuration, the braided fabric being configured to separate and be removed to deploy the medical device, and at least one second restraint fiber arranged with the at least one first restraint fiber, the at least one second restraint fiber having at least one loop arranged in a non-braided fabric pattern; and unwinding the restraint by applying tension to an end of the at least one second restraint fiber.

[0018] According to another example, further to the method of Example 13 (“Example 14”), at least one loop arranged in a non-braided fabric pattern is arranged in a chain stitch.

[0019] According to another example, further to the method of Example 13 (“Example 15”), a first row of a knot row is formed by at least one first restraint fiber in a braided fabric pattern, and a second row of the knot row is formed by at least one second restraint fiber in a non-braided fabric pattern.

[0020] According to one example (“Example 16”), a medical device deployment device includes an implantable medical device; a restraint configured to releasably constrain the implantable medical device in a constrained configuration, the restraint including: a first knot row formed by interweaving a first restraint fiber and a second restraint fiber to form a braided fabric around the medical device in a constrained configuration, and a second knot row formed by interweaving the second restraint fiber and a third restraint fiber to form a non-braided fabric around the medical device in a constrained configuration; and a deployment line coupled to the restraint and configured to untie the restraint and deploy the implantable medical device from the constrained configuration.

[0021] According to another example, further to the device of Example 16 (“Example 17”), the device further includes a third restraint fiber and a fourth restraint fiber, and wherein a third knot row formed by interweaving the third restraint fiber and the fourth restraint fiber, and a fourth knot row formed by interweaving the fourth restraint fiber and the first restraint fiber.

[0022] According to yet another example (“Example 18”) further to the device of Example 17, at least one of the third and fourth rows forms a knitted fabric around a medical device in a constrained configuration, and the other of the third and fourth rows forms a non-knitted fabric around a medical device in a constrained configuration.

[0023] According to yet another example (“Example 19”) further to the device of Example 16, the end of the first restraining fiber is joined to the end of the second restraining fiber to form a deployment line.

[0024] According to yet another example (“Example 20”) further to the device of Example 16, the restraint is circumferentially arranged around an implantable medical device, and the deployment line is configured to axially interrupt the restraint to release the second restraining fiber.

[0025] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any inventive concept provided by the present disclosure in other ways. Although multiple examples are disclosed, other examples will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples of the invention. Accordingly, the drawings and the detailed description should be regarded as illustrative in nature and not restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The drawings are provided to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description are used to explain the principles of the present disclosure.

[0027] Figure 1 is a top view of a delivery system according to an embodiment, the delivery system including a catheter having a restraint;

[0028] Figure 2 is a side view of an implantable medical device including a restraint according to an embodiment;

[0029] Figure 3 is an illustration of a first restraining fiber and a second restraining fiber according to an embodiment;

[0030] Figure 4A is an illustration of a restraint in a first arrangement according to an embodiment;

[0031] Figure 4B is a restraint in a second arrangement according to an embodiment Figure 4A as shown in;

[0032] Figure 4C is a restraint in a third arrangement according to an embodiment Figure 4A -B as shown in;

[0033] Figure 4D is an illustration of a restraint as shown in -C in a fourth arrangement according to one embodiment; Figure 4A -C;

[0034] Figure 5A is an image of a delivery system in a delivery configuration according to one embodiment; and

[0035] Figure 5B is an image of the delivery system as shown in a semi-deployed configuration according to one embodiment Figure 5A shown. DETAILED DESCRIPTION

[0036] Definitions and Terms

[0037] As used herein with respect to ranges of measurements, the terms "about" and "approximately" are used interchangeably to refer to a measurement of any measurement value that includes the stated measurement value and also includes any measurement value that is reasonably close to the stated measurement value but may vary by a relatively small amount, such relatively small amount being, as would be understood and readily determined by a person of ordinary skill in the relevant art, attributable to measurement error, differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, optimization of performance and / or adjustment of structural parameters in consideration of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and / or manipulation of objects by persons or machines, etc.

[0038] The present disclosure is not intended to be read in a limiting manner. For example, the terms used in this application should be read broadly in the context of the meanings that would be attributed to such terms by a person of ordinary skill in the art.

[0039] With respect to imprecise terms, the terms "about" and "approximately" are used interchangeably to refer to a measurement value that includes the stated measurement value and also includes any measurement value that is reasonably close to the stated measurement value. As would be understood and readily determined by a person of ordinary skill in the relevant art, the measurement value that is reasonably close to the stated measurement value deviates from the stated measurement value by a relatively small amount. For example, such deviation may be attributable to measurement error or minor adjustments made for optimization of performance. If it is determined that a person of ordinary skill in the relevant art would not readily determine the value of such relatively small difference, the terms "about" and "approximately" may be understood to be plus or minus 10% of the stated value.

[0040] Certain terms are used in this document for convenience only. For example, words such as "top", "bottom", "upper", "lower", "left", "right", "horizontal", "vertical", "upward", and "downward" merely describe the orientation of the structures or components shown in the figures in their installed positions. In reality, the components being referred to can be oriented in any direction. Similarly, throughout the disclosure, if a process or method is shown or described, the method can be performed in any order or simultaneously, unless it is clear from the context that the method depends on certain operations being performed first.

[0041] A coordinate system is presented in the figures and referred to in the description, where the "Y" axis corresponds to the vertical direction, the "X" axis corresponds to the horizontal or lateral direction, and the "Z" axis corresponds to the internal / external direction.

[0042] Description of Various Embodiments

[0043] Those skilled in the art will readily understand that various aspects of the present disclosure can be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the figures referenced herein are not necessarily drawn to scale and may be enlarged to illustrate various aspects of the present disclosure, and in this regard, the figures should not be construed as limiting.

[0044] Various aspects of the present disclosure relate to devices, systems, and methods for forming or fabricating a restraint. The restraint mechanism is configured to hold, compress, or restrain an implantable medical device (e.g., a stent, stent graft, balloon, filter, or any other expandable medical device) in a delivery configuration before and during delivery to a target location. In some cases, the restraint can include one or more fibers arranged together. The fibers can be intertwined, sutured, or otherwise interlocked circumferentially around the device. To remove the restraint, one or more fibers can be untied or disconnected from the other fibers in the restraint.

[0045] The restrained device can store energy by being constrained in a diameter smaller than its natural or deployed diameter. Thus, the device can exhibit a radial displacement force against a closure member (a pull cord). During deployment of the restrained device, the radial force can cause the restraint to untie without user participation, such that the restraint unties itself. However, aspects of the present disclosure eliminate such accelerated deployment. As discussed in more detail below, the restraint can include a pattern or knot structure that reduces accelerated deployment.

[0046] Figure 1 is a top plan view of a catheter 100 having a restraint 102 according to some embodiments. As Figure 1As shown, the restraint 102 is configured to restrain the implantable medical device 104 into a delivery configuration. The restraint 102 may include one or more fibers 106 disposed around the implantable medical device 104 to maintain the restraint 102 in a constrained configuration.

[0047] The restraint 102 is disposed along the length of the implantable medical device 104. The restraint 102 is also disposed circumferentially around the implantable medical device 104 and may substantially cover the implantable medical device 104 for delivery. One or more fibers 106 may be disposed within the lumen (not shown) of the catheter 100 and extend toward the proximal end of the catheter 100 disposed outside the patient during delivery of the implantable medical device 104. One or more fibers 106 include a proximal end 108 to which a user may apply tension to release the restraint 102 and deploy the implantable medical device 104.

[0048] In some cases, one or more fibers 106 are released similar to a pull cord such that the interlocking portions (e.g., overlapping fibers or knots) are sequentially released along the length of the implantable medical device 104. As explained in more detail below, the restraint 102 is formed by directly interlocking one or more fibers 106 together on the implantable medical device 104. Compared to existing multiple fiber restraints that are woven together and then subsequently disposed around the constrained device, the restraint 102 is formed directly on the implantable medical device 104. The expandable medical device 104 may be a stent, a stent graft, a balloon, or a similar device.

[0049] Figure 2 is a side view of the device 104 including the restraint 102 according to one embodiment. As shown, the device 104 includes a delivery diameter D1 and an expanded diameter D2 (not shown) that is greater than the delivery diameter D1. The removable restraint 102 is attached to the device 104 at the delivery diameter D1. As shown, the restraint 102 includes at least one restraint fiber in the form of a woven fabric. For example, the restraint 102 may include a first restraint fiber 110 and a second restraint fiber 112. The first restraint fiber 110 and / or the second restraint fiber 112 may operate, for example, as a deployment line 120 that is configured to release the restraint 102 and convert the device 104 from the delivery diameter D1 to the expanded diameter D2 in response to a force applied to the deployment line 120 (which may be coupled to one or more knot rows 114, as discussed in more detail below).

[0050] Device 104 may have a desired deployed diameter D2, such as about 5 mm - 15 mm, or 6 mm - 9 mm, or 6 mm - 12 mm, 10 mm - 20 mm, 15 mm - 30 mm, 25 mm - 45 mm, and a delivery diameter D1 that is less than the deployed diameter D2. For example, in some cases, the ratio of the delivery diameter D1 of device 104 to the deployed diameter D2 (not shown) of 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. For reference, the term "diameter" does not mean that a circular cross-section is required, but is broadly understood to refer to the maximum cross-sectional dimension of device 104 across its width.

[0051] Figure 3 is an illustration of a first restraint fiber 110 and a second restraint fiber 112 according to an embodiment. The first restraint fiber 110 and the second restraint fiber 112 each include a series of loops 220, 222, respectively. A single loop in the series of loops 220, 222 is highlighted in Figure 3 for purposes of illustration. In some cases, the first restraint fiber 110 and the second restraint fiber 112 may form a medical device deployment apparatus. In some cases, the first restraint fiber 110 and the second restraint fiber 112 are formed from a single restraint fiber that loops back on itself to form two strands 110, 112.

[0052] In addition, the loops 220 of the first restraint fiber 110 may form a braid that surrounds a medical device in a constrained configuration, as Figure 3 shown. As discussed in more detail below with reference to Figure 4A -D, the first restraint fiber 110 that forms the braid may be one of a group of fibers that form the braid in one or more rows of the restraint 102. The loops 222 of the second restraint fiber 112 may be arranged with the first restraint fiber 110 such that the second restraint fiber 112 has at least one loop 224 arranged in a non-braid pattern. As Figure 3 shown, the at least one loop 224 is the outermost loop of the plurality of loops 222. In some cases, each loop 22 of the second restraint fiber 112 may include a non-braid pattern. As described above, the first restraint fiber 110 and the second restraint fiber 112 may form the restraint 102. In some cases, the loop 224 having a non-braid pattern is arranged at the distal end of the restraint 102. In some cases, the loop 224 may be arranged in a chain stitch. The at least one loop 224 arranged in a non-braid pattern is arranged with the non-braid pattern and interrupts the braid.

[0053] The first restraining fiber 110 can be interwoven with the second restraining fiber 112 to form a restraint 102, wherein each of the first restraining fiber 100 and the second restraining fiber 122 forms a row of knots. As Figure 3 shown, the first restraining fiber 110 and the second restraining fiber 112 are interwoven to form a single row of knots 226. As discussed and Figure 4A -B shows, the restraint 102 can include additional rows of knots 226.

[0054] The restraint 102 can be deployed by applying tension to the deployment line to break the row of knots 226. In some cases, the first restraining fiber 110 and the second restraining fiber 112 can be combined to form the deployment line.

[0055] The row of knots 226 can be one of a plurality of rows formed in the restraint 102. In some cases, the first restraining fiber 110 can include multiple fibers woven together. The first restraining fiber 110 can be a group or type of fibers forming a pattern. Similarly, the second restraining fiber 112 can be a group or type of fibers forming a pattern. For example, the first row of the row of knots formed by the first restraining fiber 110 (group) can be a warp knitted fabric pattern, and the second row of the row of knots is formed by the second restraining fiber 112 (group) of a non-warp knitted fabric pattern. In some cases, the non-warp knitted fabric pattern of the second row includes a chain stitch. In these cases, at least one first restraining fiber 110 includes the first restraining fiber 110 and a third restraining fiber, and at least one second restraining fiber 112 includes the second restraining fiber 112 and a fourth restraining fiber, wherein the first restraining fiber, the second restraining fiber, the third restraining fiber, and the fourth restraining fiber are interwoven to form the restraint 102, as discussed with reference to Figure 4A -D.

[0056] The non-warp knitted fabric pattern, knot, or stitch used in the restraint 102, including one or more additional rows of knots (these rows are formed as a knitted fabric or a warp knitted fabric), reduces the chance of the restraint 102 deploying itself. In some cases, the chain stitch formed by one loop 224 in the row 226 or all of the loops in the row of the restraint 102, including one or more additional rows of knots (these rows are formed as a knitted fabric or a warp knitted fabric), helps with the controlled deployment of the restraint 102.

[0057] Figure 4A is an illustration of the restraint 102 in a first arrangement according to an embodiment. The restraint 102 is shown as a sheet of interwoven fibers, however, the restraint 102 can be circumferentially arranged around an implantable medical device. The restraint 102 can include the first restraining fiber 110 and the second restraining fiber 112 as described above with reference to Figure 3 forming a plurality of rows of knots. For example and as Figure 4AAs shown, the restraint member 102 includes a first restraint fiber 110, a second restraint fiber 112, a third restraint fiber 338, and a fourth restraint fiber 340. The restraint fibers 110, 112, 338, 340 can be arranged together to form a plurality of knot rows 342, 344, 346, 348. In some cases, the number of restraint fibers 110, 112, 338, 340 can be equal to the number of knot rows 342, 344, 346, 348. Additionally, the restraint fibers 110, 112, 338, 340 can be intertwined or interlocked with each other to form the knot rows 342, 344, 346, 348.

[0058] In some cases, the first knot row 342 of the restraint member 102 can be formed by the first restraint fiber 110 being intertwined with the second restraint fiber 112. As shown, the first restraint fiber 110 is intertwined with the second restraint fiber 112 to form the knot row 342 in the warp knitted fabric. When the restraint member 102 is around a medical device in a constrained configuration, the knot row 342 can be a warp knitted fabric.

[0059] Furthermore, the second knot row 344 can be formed by the second restraint fiber 112 being intertwined with the third restraint fiber 338. The second restraint fiber 112 can be intertwined with the third restraint fiber 338 to form a non - warp knitted fabric with the knot row 344. When the restraint member 102 is around a medical device in a constrained configuration, the knot row 344 can be a warp knitted fabric.

[0060] As Figure 4A shown, the restraint member 102 includes a plurality of knot rows 342, 344, 346, 348, where the first knot row 342 is formed by the first restraint fiber 110 being intertwined with the second restraint fiber 112, the second knot row 344 is formed by the second restraint fiber 112 being intertwined with the third restraint fiber 388, the third knot row 346 is formed by the third restraint fiber 348 being intertwined with the fourth restraint fiber 340, and the fourth knot row 348 is formed by the fourth restraint fiber 340 being intertwined with the first restraint fiber 110.

[0061] In some cases, one or more of the rows 342, 344, 346, 348 form a knitted or warp knitted fabric pattern with loops of the restraint fibers 110, 112, 338, 340, and another one or more of the rows 342, 344, 346, 348 form a knitted or warp knitted fabric pattern with one or more loops of the restraint fibers 110, 112, 338, 340 (e.g., refer to Figure 3The distal loop) forms a non-woven or non-warp knitted pattern. In some cases, at least one of the third row 346 and the fourth row 348 forms a warp knitted fabric around the medical device in a constrained configuration, and the other of the third row 346 and the fourth row 348 forms a non-warp knitted fabric around the medical device in a constrained configuration. The restraint 102 may include three rows 342, 344, 346, 348 in the form of warp yarns and one of the rows 342, 344, 346, 348 in the form of non-warp yarns. One or more of the rows 342, 344, 346, 348 in the form of non-warp yarns include a single knot arranged in a non-warp stitch (e.g., a chain stitch), two or more of the knots in one or more of the rows 342, 344, 346, 348 are non-warp stitches, a plurality of the knots in one or more of the rows 342, 344, 346, 348 are non-warp stitches, alternating knots in one or more of the rows 342, 344, 346, 348 are non-warp stitches, two or more or all of the knots in one or more of the rows 342, 344, 346, 348 are non-warp stitches.

[0062] The non-warp pattern of one or more of the rows 342, 344, 346, 348 may reduce the chance of accelerated or undesired deployment of the restraint 102. Different non-warp patterns of one or more of the rows 342, 344, 346, 348 disrupt the pattern of the restraint 102.

[0063] The deployment line 350 may be coupled to the end of the second restraint fiber 112 (e.g., a fiber having one or more non-warp knitted knots) to force the deployment of the restraint 102. The end of the first restraint fiber 110 is joined to the end of the second restraint fiber 112, and they may be combined to form the deployment line 350. In other cases, the deployment line 350 is the second restraint fiber 112 or a separate line or wire. In some cases, the deployment line 350 is configured to untie the second restraint fiber 112 and deploy the implantable medical device from the constrained configuration. As described above, the restraint 102 may be circumferentially arranged around the implantable medical device, and the deployment line 350 may be configured to axially interrupt the restraint 102 to untie the second restraint fiber 112, as Figure 4B shown in -C.

[0064] Figure 4B -C is Figure 4A an illustration of the restraint shown in, at different steps of untying the restraint 102. As Figure 4A shown in -D, A-H are position indicators for portions or segments of the second restraint fiber 112. In comparing Figure 4A and Figure 4BWhen the second restraining fiber 112 in it is arranged, the loop or chain stitch D has been axially pulled. Pulling the section A of the second restraining fiber 112 further removes the slack residue from the loop D section of the second restraining fiber 112, and shows that the warp knitting rows 342, 346, 348 hold the restraint 102 together (for example, as Figure 4B shown in -C).

[0065] In some cases, the second restraining fiber 112 may include a warp knitted fabric in the knot row 344 after the loop or chain stitch D. Pulling the second restraining fiber 112 or the deployment thread 350 will also loosen the section E of the warp knitted fabric of the second restraining fiber 112. Figure 4C The loop E of the second restraining thread 112 pulled out from row 344 is shown. The next knot in row 344 can be a chain stitch, which requires an axial load to be applied to the second restraining fiber 112 or the deployment thread 350. Since the sections of the second restraining fiber 112 are removed from the knot row 344, these sections become part of the deployment thread 350. The remaining sections of the second restraining fiber 112 can be warp knitted knots or non-warp knitted knots.

[0066] Figure 5A is an image of the delivery system 10 in a delivery configuration according to an embodiment. Figure 5B is an image of the delivery system 10 in a semi-deployed configuration according to an embodiment. As shown, breaking (interrupting) one of the restraining fibers of the knot row (for example, the second restraining fiber 112) causes at least a part of the restraint 102 to start to unwind, as Figure 5B shown.

[0067] The inventive concept of the present application has been generally described above and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and changes can be made to the embodiments without departing from the scope of the present disclosure. Therefore, it is intended that the embodiments cover modifications and variations of the inventive concept as long as they fall within the scope of the appended claims and their equivalents.

Claims

1. A medical device deployment device, the device comprising: at least one first restraint fiber, the at least one first restraint fiber being arranged as a series of multiple loops to form a warp knitted fabric around a medical device in a constrained configuration, the warp knitted fabric being configured to separate from the medical device at a knit row of the warp knitted fabric and being removed to deploy the medical device; and at least one second restraint fiber, the at least one second restraint fiber being arranged together with the at least one first restraint fiber to form the knit row of the warp knitted fabric, the at least one second restraint fiber having at least one distal loop that interrupts the warp knitted fabric in a non-warp knitted pattern.

2. The device according to claim 1, wherein, the at least one first restraint fiber comprises a plurality of fibers woven together.

3. The device according to any one of claims 1-2, wherein, the first restraint fiber and the at least one second restraint fiber form a restraint member, and the at least one loop arranged in the non-warp knitted pattern is arranged at a distal end of the restraint member.

4. The device according to claim 3, wherein, the at least one loop arranged in the non-warp knitted pattern is arranged in a chain stitch.

5. The device according to claim 4, wherein, the at least one first restraint fiber is intertwined with the at least one second restraint fiber to form a restraint member, wherein each of the at least one first restraint fiber and the at least one second restraint fiber forms a knit row.

6. The device according to claim 5, wherein, the first row of the knit row is formed by the at least one first restraint fiber in the warp knitted pattern, and the second row of the knit row is formed by the at least one second restraint fiber in the non-warp knitted pattern.

7. The device according to claim 6, wherein, the non-warp knitted pattern of the second row includes a chain stitch.

8. The device according to claim 1, wherein, the at least one first restraint fiber comprises the first restraint fiber and a third restraint fiber, and the at least one second restraint fiber comprises a second restraint fiber and a fourth restraint fiber, wherein the first restraint fiber, the second restraint fiber, the third restraint fiber and the fourth restraint fiber are intertwined to form a restraint member.

9. The device according to claim 8, wherein, the restraint member includes a plurality of knit rows, the plurality of knit rows including a first knit row formed by the first restraint fiber intertwined with the second restraint fiber, a second knit row formed by the second restraint fiber intertwined with the third restraint fiber, a third knit row formed by the third restraint fiber intertwined with the fourth restraint fiber, and a fourth knit row formed by the fourth restraint fiber intertwined with the first restraint fiber.

10. The device according to claim 9, wherein, at least one of the plurality of knots forms a warp knitted fabric around the medical device in the constrained configuration, and another of the plurality of knots forms a non-warp knitted fabric around the medical device in the constrained configuration.

11. The device according to claim 1, Characterized in that, The at least one first restraining fiber and the at least one second restraining fiber are combined to form a deployment line.

12. The device according to claim 1, Characterized in that, The warp knitted fabric is configured to separate and be removed to deploy the medical device, and the warp knitted fabric is arranged such that the non-warp knitted pattern interrupts the warp knitted fabric.

13. A medical device deployment device, the device Comprises: An implantable medical device; A restraint configured to releasably restrain the implantable medical device in a restrained configuration, the restraint comprising: A first row of knots formed by interweaving a first restraining fiber and a second restraining fiber to form a warp knitted fabric around the medical device in the restrained configuration, and A second row of knots formed by interweaving the second restraining fiber and a third restraining fiber, wherein the second row of knots forms a non-woven pattern with at least one loop of the second restraining fiber and the third restraining fiber, and wherein the at least one loop arranged in the non-woven pattern is arranged together with the non-woven pattern and interrupts the warp knitted fabric; and A deployment line coupled to the restraint and configured to interrupt the restraint when tensioned to release the second restraining fiber, thereby deploying the implantable medical device from the restrained configuration.

14. The device according to claim 13, Characterized in that, It further comprises a third restraining fiber and a fourth restraining fiber, and wherein, a third row of knots formed by interweaving the third restraining fiber and the fourth restraining fiber, and a fourth row of knots formed by interweaving the fourth restraining fiber and the first restraining fiber.

15. The device according to claim 14, Characterized in that, At least one of the third row and the fourth row forms a warp knitted fabric around the medical device in the restrained configuration, and the other of the third row and the fourth row forms a non-warp knitted fabric around the medical device in the restrained configuration.

16. The device according to claim 13, Characterized in that, The ends of the first restraining fiber and the ends of the second restraining fiber are joined to form the deployment line.

17. The device according to claim 13, Characterized in that, The restraint is circumferentially arranged around the implantable medical device, and the deployment line is configured to axially interrupt the restraint to release the second restraining fiber.

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