Constraint mechanism for selective deployment and associated methods

Abstract

Aspects of the present disclosure relate to apparatus, systems, and methods for deploying medical devices. The apparatus, systems, and methods can include at least one restraint fiber disposed about a periphery of a medical device and a braided fabric configured to separate to deploy the medical device to at least one intermediate restrained configuration and to a fully deployed configuration.

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 staged deployment of expandable devices during device delivery. Background Art

[0002] Stents and stent grafts can be used to radially support various tubular passages 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: a 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 recovering from a collapsed or constrained delivery diameter to an expanded and deployed diameter. Some stents are designed to elastically recover by being made of a material with elastic recovery 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 restraint fiber disposed about a periphery of the medical device and including a series of multiple loops that are intertwined at a first position to form a knitted fabric, at least one of the multiple loops being disposed at least partially about the periphery of the medical device and joined together at a second position, the knitted fabric being configured to separate to deploy the medical device to at least one intermediate constrained configuration and a fully deployed configuration.

[0006] According to another example ("Example 2") further to the apparatus of Example 1, the at least one restraint fiber includes multiple restraint fibers that are intertwined to form a series of multiple loops.

[0007] According to another example ("Example 3") further to the apparatus of Example 2, the series of multiple loops forms a row of knots at the first position, and the loop-forming portions of the multiple loops extend at least partially about the periphery of the medical device and are joined together at the second position.

[0008] According to yet another example, further to the device of Example 3 (“Example 4”), the device further includes a removable restraint that is arranged to pass through the looping portions of a plurality of loops to join the looping portions together at a second position.

[0009] According to yet another example, further to the device of Example 4 (“Example 5”), the removable restraint is configured to be withdrawn from the looping portions of the plurality of loops to deploy the medical device to at least one intermediate restrained configuration.

[0010] According to yet another example, further to the device of any one of Examples 2-5 (“Example 6”), the at least one intermediate restrained configuration includes a first intermediate restrained configuration and a second intermediate restrained configuration, a plurality of restraint fibers are joined at a second position and at a third position, and the plurality of restraint fibers are configured to separate at the third position to deploy the medical device to the second intermediate restrained configuration, and to separate at the second position to deploy the medical device to the first intermediate restrained configuration.

[0011] According to yet another example, further to the device of Example 6 (“Example 7”), the device further includes a second removable restraint that is configured to join the plurality of restraint fibers at the third position, and wherein the removable restraint is configured to join the plurality of restraint fibers at a second position.

[0012] According to yet another example, further to the device of Example 7 (“Example 8”), the second removable restraint is arranged to pass through the looping portions of the plurality of loops, and the second removable restraint is configured to be withdrawn from the looping portions to separate the plurality of restraint fibers at the third position to deploy the medical device to the second intermediate restrained configuration.

[0013] According to yet another example, further to the device of any one of Examples 6-8 (“Example 9”), the plurality of restraint fibers are configured to deploy to the first intermediate restrained configuration and arrange at least a portion of the medical device at a first intermediate diameter, and to deploy to the second intermediate restrained configuration to arrange at least a portion of the medical device at a second intermediate diameter.

[0014] According to yet another example, further to the device of Example 9 (“Example 10”), the plurality of restraint fibers are configured to deploy to the first intermediate restrained configuration and arrange an end portion of the medical device at the first intermediate diameter, and to hold an intermediate portion of the medical device in the restrained configuration.

[0015] According to yet another example, further to the device of any one of Examples 4-10 (“Example 11”), the removable restraint includes a pawl.

[0016] According to yet another example (“Example 12”) further to the apparatus according to any one of Examples 4 - 10, the removable restraint includes fibers.

[0017] According to one example (“Example 13”), a method of forming a restraint for a medical device deployment apparatus includes: arranging restraint fibers around a medical device to form a restraint, and placing the medical device in a constrained configuration, the restraint including restraint fibers arranged around a periphery of the medical device and intertwined at a first location to form a row of knots; forming a plurality of loops in series with the restraint fibers after forming the row of knots, wherein the plurality of loops are arranged at least partially around the periphery of the medical device starting from the row of knots; and arranging a removable restraint, the removable restraint being arranged to pass through the plurality of loops to hold the plurality of loops.

[0018] According to yet another example (“Example 14”) further to the method according to Example 13, arranging restraint fibers around a medical device includes forming a warp knitted fabric including a row of knots.

[0019] According to yet another example (“Example 15”) further to the method according to the example, arranging restraint fibers around a medical device in the row of knots includes placing the medical device at a first diameter, and forming a plurality of loops in series includes placing the medical device at a second diameter smaller than the first diameter.

[0020] According to one example (“Example 16”), a medical device deployment apparatus includes: an implantable medical device; a restraint arranged around a periphery of the implantable medical device and configured to releasably constrain the implantable medical device in a constrained configuration, the restraint including: restraint fibers arranged around the periphery of the medical device and intertwined at a first location to form a row of knots, and a plurality of loops in series arranged at least partially around the periphery of the medical device starting from the row of knots; and a removable restraint arranged to pass through the plurality of loops and configured to be withdrawn from the plurality of loops to release the restraint and the implantable medical device to an intermediate configuration.

[0021] According to yet another example (“Example 17”) further to the apparatus according to Example 16, the row of knots is configured to hold at least a portion of the medical device at a first diameter, and the plurality of loops in the series includes placing the medical device at a second diameter smaller than the first diameter.

[0022] According to yet another example (“Example 18”) further to the apparatus according to Example 17, the row of knots is configured to hold an end portion of the medical device at a first diameter, and the plurality of loops in the series is configured to hold a length of the medical device in the constrained configuration.

[0023] According to another example (“Example 19”) further to the device of Example 17, a plurality of rings in series are arranged 180 degrees around the periphery of the medical device starting from the knot row, and the first diameter is approximately 50% larger than the second diameter.

[0024] According to another example (“Example 20”) further to the device of Example 16, the knot row is configured to untie to deploy the implantable medical device to a fully deployed configuration.

[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 a plurality of 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 present 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 used 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 an example restraint according to an embodiment;

[0030] Figure 4 is an illustration of another example restraint according to an embodiment;

[0031] Figure 5 is an illustration of another example restraint according to an embodiment;

[0032] Figure 6 is an illustration of another example restraint according to an embodiment;

[0033] Figure 7A -C shows an illustration of a deployment stage of an implantable medical device using a restraint according to an embodiment; and

[0034] Figure 8A -C shows an illustration of a deployment stage of an implantable medical device using a restraint according to an embodiment. DETAILED DESCRIPTION

[0035] Definitions and Terms

[0036] As used herein with respect to ranges of measured values, the terms "about" and "approximately" are used interchangeably to refer to a measured value that includes the stated measured value and also includes any measured value that is reasonably close to the stated measured value but may vary by a reasonably small amount, such as may be attributable to measurement error, differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, adjustment of optimized performance and / or 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., as would be understood and readily determined by one of ordinary skill in the relevant art.

[0037] This disclosure is not intended to be read in a limiting sense. For example, terms used in this application should be read broadly in the context of the meanings that one of ordinary skill in the art would ascribe to such terms.

[0038] With respect to imprecise terms, the terms "about" and "approximately" are used interchangeably to refer to a measured value that includes the stated measured value and also includes any measured value that is reasonably close to the stated measured value. As would be understood and readily determined by one of ordinary skill in the relevant art, a measured value that is reasonably close to the stated measured value deviates from the stated measured value by a reasonably small amount. For example, such deviation may be attributable to measurement error or minor adjustment for optimized performance. If it is determined that one of ordinary skill in the relevant art would not readily determine the value of such a reasonably small difference, the terms "about" and "approximately" may be understood to be plus or minus 10% of the stated value.

[0039] Certain terms are used herein solely for convenience. 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 fact, the components being referred to may be oriented in any direction. Similarly, throughout the disclosure, if a process or method is shown or described, the method may be performed in any order or simultaneously, unless it is clear from the context that the method depends on certain operations being performed first.

[0040] 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.

[0041] Description of Various Embodiments

[0042] Those skilled in the art will readily appreciate that aspects of the present disclosure can be implemented by any number of methods and apparatuses configured to perform the desired functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be enlarged to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting.

[0043] Aspects of the present disclosure relate to devices, systems, and methods including 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 may include one or more fibers arranged together. The fibers may be intertwined, sutured, or otherwise interlocked circumferentially around the device. To remove the restraint, one or more fibers may be untied or disconnected from the other fibers in the restraint.

[0044] Aspects of the present disclosure relate to using a restraint to control the deployment of a medical device. In some cases, it may be beneficial to deploy at least a portion of the medical device to an intermediate diameter greater than the constrained diameter. For example, a doctor may deploy the medical device to the intermediate diameter and visualize the position of the medical device within the patient. The doctor may adjust the position or angle of the medical device at the intermediate diameter and then deploy the medical device to another, not fully deployed, diameter or fully deploy the device. As discussed in further detail below, the restraint may be formed of one or more restraint fibers that may be arranged to form a restraint that allows for staged deployment of the implantable device.

[0045] Figure 1 is a top plan view of a catheter 100 having a restraint 102 according to some embodiments. As Figure 1 shown, the restraint 102 is configured to restrain an 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.

[0046] 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 proximally 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.

[0047] 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 interlocking one or more fibers 106 that are disposed directly on the implantable medical device 104. Compared to existing multi-fiber restraints that are knitted together and then subsequently disposed around the constrained device, the restraint 102 is formed directly on the implantable medical device 104. The implantable medical device 104 can be a stent, a stent graft, a balloon, or a similar device.

[0048] Figure 2 FIG. 4 is a side view of a device 104 including a 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 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 two interlocking strands in a warp knit form. For example, the restraint 102 can include a first interlocking strand 110 and a second interlocking strand 112. The first interlocking strand 110 and / or the second interlocking strand 112 can 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 deployed diameter D2 (which can be coupled to one or more knot rows 114, as discussed further in detail below) in response to a force applied to the deployment line 120.

[0049] The device 104 can have a desired deployed diameter D2 of, for example, 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 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. By reference, the term "diameter" does not mean that a circular cross-section is required, but is widely understood to refer to the maximum cross-sectional dimension of the device 104.

[0050] Figure 3 FIG. 11 is an illustration of an exemplary restraint 102 according to an embodiment. The restraint 102 can be or form part of a deployment device for a medical device (e.g., as Figures 1 - 2 shown). As Figure 3 shown, the restraint 102 can include at least one restraint fiber 110 disposed around the periphery of the medical device. The restraint fiber 110 can be formed into a series of multiple loops 222. A single loop in the loops 222 is Figure 3 highlighted in FIG. 16 for purposes of illustration.

[0051] Multiple loops 222 of the series are intertwined at a first location to form a knitted fabric (shown in more detail with reference to FIGS. 7-8). Additionally, multiple loops 222 can be intertwined in a knot row. After forming a knot row, a series of knots, or a seam, one or more loops 222 can be disposed at least partially around the periphery of the medical device and can be joined together at a second location, as Figure 3 shown. The knitted fabric is configured to separate to deploy the medical device to at least one intermediate constrained configuration and a fully deployed configuration.

[0052] In some cases, loops 222 are held or joined on opposite sides or circumferentially opposite sides of the knot row. In other cases, loops 222 can be wound circumferentially around the medical device to cover or approximately cover the knot row. Loops 222 can be wound around the medical device any amount starting from the knot row. In some cases, the restraint fibers 110 are folded to form loops 222 that are knitted together to form a knot row. The distal portion of the loop 222 is the looping portion 224. The looping portions 224 of the multiple loops 222 can extend at least partially around the periphery of the medical device to be joined together at a second location. To join the multiple loops 222, and more particularly the looping portions 224 of the multiple loops 222, a removable restraint 226 can be arranged to pass through the looping portions 224.

[0053] As Figure 3 shown, the removable restraint 226 is arranged to pass through the looping portions 224 of the multiple loops 222 to join the looping portions 224 together at a second location. In some cases, the looping portions 224 of the multiple loops 222 can be intertwined together at the second location to join, the looping portions 224 of the multiple loops 222 can be adhesively bonded together at the second location to join, or the looping portions 224 of the multiple loops 222 can be secured to other portions of the restraint fibers 110 to join.

[0054] To form the restraint 102, the restraint fibers 110 can be arranged around the medical device to place the medical device in a constrained configuration. The restraint fibers 110 can be intertwined at a first location to form a knot row. The restraint fibers 110 can be formed into a series of loops 222 before or after being intertwined to form a knot row (e.g., the restraint 102 can be in the form of a knitted fabric). The loops 222 can then be arranged separately from the knot row at least partially around the periphery. To join the loops 222, a removable restraint 226 passes through the multiple loops 222 to hold the multiple loops 222 in a second location.

[0055] The loop 222 that is held together with the removable restraint 226 constructs the restraint 102 for the staged deployment of a medical device. The loop 222 that forms a row of knots and wraps around the periphery of the medical device constrains the device to an additional second diameter that is less than the case where the restraint 102 includes a single row of knots. The removable restraint 226 holds the loop 222 and can be withdrawn to release the loop 222. Releasing the loop 222 causes the restraint 102 and the medical device to expand to an intermediate diameter. Due to the row of knots, the restraint 102 remains intact, and the row of knots can be undone to fully deploy the medical device, as shown in more detail with reference to FIGS. 7-8.

[0056] In some cases, arranging the restraint fibers 110 around the medical device in a row of knots includes arranging the medical device at a first diameter, and forming a plurality of loops 222 in series includes arranging the medical device at a second diameter that is less than the first diameter (e.g., as shown in more detail in FIGS. 7-8). Forming the restraint 102 in this manner can form a staged deployment restraint 102. The restraint fibers 110 can be wound around the medical device for the first time when forming the row of knots and a second time (or a portion of a rotation) around the loops 222. Thus, the loops 222 can fully constrain the device, and when the releasable restraint 226 is withdrawn, the row of knots can release the device to an intermediate diameter that is twice the fully constrained diameter. The diameter difference can depend on the amount of winding of the restraint fibers 110. Additionally, the restraint fibers 110 can be wound around portions of the medical device such that those portions of the device can be deployed to the intermediate diameter. Further, the restraint fibers 110 and the removable restraint 226 can be one of multiple restraint fibers 110 and removable restraints 226 in the restraint 102.

[0057] In some cases, the loop 222 is arranged 180 degrees around the periphery of the medical device starting from the row of knots, and the first diameter is approximately 50% larger than the second diameter. Additionally, the removable restraint 226 can be a detent (e.g., metal or metal-containing) or the removable restraint 226 can be a fiber.

[0058] Figure 4 is an illustration of another exemplary restraint 102 according to an embodiment. The restraint 102 includes restraint fibers 110 arranged around the medical device in a warp-knit (fabric) pattern. The restraint fibers 110 include a first row of knots 330 and a second row of knots 332. The first row of knots 330 and the second row of knots 332 are arranged on diametrically opposite sides of the restraint 102.

[0059] In some cases, the restraining fibers 110 are wound circumferentially around the medical device and intertwined at a first location and a second location to form a first knot row 330 and a second knot row 332. The first knot row 330 and the second knot row 332 may be disposed on diametrically opposite sides of the restraint 102 such that the restraint 102 is configured for staged deployment.

[0060] The removable restraint 226 is disposed to pass through the looped portions 222 of the first knot row 330 and the second knot row 332. Tension may be applied to the distal end 334 to withdraw the removable restraint 226. In response to the tension applied to the distal end 334 of the removable restraint 226 (which may be accessible to the doctor), the removable restraint 226 may be disassembled or disengaged from the first knot row 330 and the second knot row 332. In some cases, the removable restraint 226 is withdrawn through the second knot row 332 before the first knot row 330. In some cases, the removable restraint 226 is withdrawn through the second knot row 332 simultaneously with the first knot row 330.

[0061] In some cases, the removable restraint 226 is withdrawn through the first knot row 330 and the second knot row 332 to enable the medical device to expand to a diameter greater than the constrained diameter. The constrained diameter of the restraint 102 is the minimum diameter of the medical device when disposed within the restraint 102 and when the removable restraint 226 is disposed to pass through the looped portion 222 of the first knot row 330 and through the looped portion 222 of the second knot row 332. In some cases, the removable restraint 226 is withdrawn through the first knot row 330 such that the medical diameter can expand to a first intermediate diameter and is withdrawn through the second knot row 332 such that the medical diameter can expand to a second intermediate diameter (greater than the first intermediate diameter), as shown in more detail with reference to FIGS. 7-8.

[0062] After the removable restraint 226 is withdrawn through the first knot row 330 and the second knot row 332, the restraint 102 may be disassembled to enable the medical device to expand to a fully deployed diameter. The deployment line 336 may be coupled to the restraining fibers 110 (or the restraining fibers 110 may include a doctor-accessible distal end). Tension applied to the deployment line 336 may disassemble the restraint 102. In some cases, tension applied to the deployment line 336 may disassemble or untie the first knot row 330 and the second knot row 332 to enable the medical device to expand to a fully deployed diameter.

[0063] Figure 5FIG. 0 is an illustration of another exemplary restraint 102 according to one embodiment. The restraint 102 includes a first restraint fiber 110 and a second restraint fiber 112 arranged in a braided fabric pattern around a medical device. The first restraint fiber 110 and the second restraint fiber 112 at least include a first knot row 330 and a second knot row 332. The first knot row 330 and the second knot row 332 are arranged on diametrically opposite sides of the restraint 102. In some cases, the first restraint fiber 110 and the second restraint fiber 112 may form additional knot rows arranged at different diametric portions of the restraint 102.

[0064] In some cases, the first restraint fiber 110 and the second restraint fiber 112 are wound circumferentially around the medical device and intertwined at a first location and a second location to form the first knot row 330 and the second knot row 332 (each knot row may include a loop portion 222).

[0065] As Figure 5 shown, a first removable restraint 226 is arranged to pass through a portion of the first knot row 330, and a second removable restraint 438 is arranged to pass through the second knot row 332. Tension can be applied to the distal ends of each of the first removable restraint 226 and the second removable restraint 338, thereby individually withdrawing the first removable restraint 226 and the second removable restraint 338. In response to the tension applied to the distal ends (which may be accessible to a doctor), the first removable restraint 226 and the second removable restraint 338 can be withdrawn from the first knot row 330 and the second knot row 332.

[0066] In some cases, the first removable restraint 226 and the second removable restraint 338 are withdrawn to effect a staged deployment of the medical device. The first removable restraint 226 is withdrawn through (across) the first knot row 330 to enable the medical device to expand to a first intermediate diameter greater than the constrained diameter. The constrained diameter of the restraint 102 is the minimum diameter of the medical device when arranged within the restraint 102 and when the first removable restraint 226 and the second removable restraint 338 are arranged to pass through the first knot row 330 and through the second knot row 332. To effect the second stage of deployment, the second removable restraint 338 is withdrawn through the second knot row 332 such that the medical diameter can expand to a second intermediate diameter (greater than the first intermediate diameter), as shown in more detail with reference to FIGS. 7-8.

[0067] After the first removable restraint 226 is withdrawn through the first knot row 330 and the second removable restraint 338 is withdrawn through the second knot row 332, the restraint 102 can be disassembled so that the medical device can expand to its fully deployed diameter. The deployment line 336 can be coupled to the first restraint fiber 110, the second restraint fiber 112, both the first restraint fiber 110 and the second restraint fiber 112, or the first restraint fiber 110 and the second restraint fiber 112 can be coupled together to form the deployment line 336. The deployment line 336 can include a distal end accessible to the doctor. Tension applied to the deployment line 336 can disassemble the restraint 102. In some cases, tension applied to the deployed tension line 336 can disassemble or untie the first knot row 330 and the second knot row 332 so that the medical device can expand to its fully deployed diameter.

[0068] Figure 6 FIG. is an illustration of another exemplary restraint 102 according to one embodiment. The restraint 102 includes a first restraint fiber 110, a second restraint fiber 112, and a third restraint fiber 542 arranged around the medical device in a knitted fabric pattern. The restraint fibers 110, 112, 542 include at least a first knot row 330, a second knot row 332, and a third row of knots 540. The knot rows 330, 332, 540 (each of which can include a looping portion 222) are arranged at different positions on the diameter of the restraint 102.

[0069] As Figure 6 shown, the first removable restraint 226 is arranged to pass through a portion of the first knot row 330, while the second removable restraint 338 is arranged to pass through the second knot row 332, and the third removable restraint 542 is arranged to pass through the third row of knots 540. Tension can be applied to the distal ends of each of the first removable restraint 226, the second removable restraint 338, and the third removable restraint 542 to individually withdraw the first removable restraint 226, the second removable restraint 338, and the third removable restraint 542.

[0070] In some cases, each of the first removable restraint 226, the second removable restraint 338, and the third removable restraint 542 is withdrawn to effect a staged deployment of the medical device. The first removable restraint 226 is withdrawn through the first knot row 330 so that the medical device can expand to a first intermediate diameter greater than the constrained diameter. To effect a second stage of deployment, the second removable restraint 338 is withdrawn through the second knot row 332 so that the medical diameter can expand to a second intermediate diameter (greater than the first intermediate diameter). To effect a third stage of deployment, the third removable restraint 544 is withdrawn through (by) the third row of knots 540 so that the medical diameter can expand to a third intermediate diameter (greater than the first intermediate diameter and the second intermediate diameter), as shown in more detail with reference to FIGS. 7-8.

[0071] After the removable restraints 226, 438, 544 are withdrawn, the restraint 102 can be disassembled so that the medical device can expand to a fully deployed diameter.

[0072] Figure 7A -C shows illustrations of various stages of deployment of an implantable medical device using the restraint 102. The restraint 102 is disposed about the periphery of the implantable medical device 104 ( Figure 7C as shown in) and is configured to releasably restrain the medical device 104 in a constrained configuration as Figure 7A shown. The constrained configuration positions the medical device at a first diameter D1. The restraint 102 can be any of the restraints shown in Figures 3 - 6 which includes at least one restraint fiber 110 disposed about the periphery of the medical device 104. The (at least one) restraint fiber 110 is intertwined at a first location to form a row of knots 330 and a series of multiple loops 332 disposed at least partially about the periphery of the medical device 104 from the row of knots 330. In some cases, the multiple loops 332 can be a second row of knots (e.g., each row of knots includes loops 222), as described in more detail above with reference to Figures 3 - 6 shown.

[0073] The removable restraint 226 is disposed to pass through the multiple loops 332 (e.g., the second row of knots). The removable restraint 226 is configured to be withdrawn from the multiple loops 332 to release the restraint 102 and the implantable medical device 104 to an intermediate configuration. As Figure 7B shown, the implantable medical device 104 (and the restraint 102) expands to a second diameter D2 in the intermediate configuration. The second diameter D2 is greater than the first diameter D1.

[0074] In some cases and as described above, the intermediate constrained configuration as Figure 7B shown includes a first intermediate constrained configuration and a second intermediate constrained configuration. In these cases, the restraint fiber 110 (or multiple restraint fibers) can be joined at a second location and joined at a third location. In these cases, one or more restraint fibers 110 are configured to separate at the third location to deploy the medical device 104 to the second intermediate constrained configuration and separate at the second location to deploy the medical device 104 to the first intermediate constrained configuration.

[0075] To deploy the medical device 104 in this manner, a second removable restraint is configured to couple the restraint fiber 110 or plural restraint fibers at a third position, and the removable restraint is configured to couple plural restraint fibers at a second position. The second removable restraint is arranged to pass through the looping portion of each loop, and the second removable restraint is configured to be withdrawn from the looping portion to separate the restraint fiber 110 or plural restraint fibers at the third position, thereby deploying the medical device 104 to a second intermediate restrained configuration. The restraint fiber 110 or plural restraint fibers are configured to deploy to a first intermediate restrained configuration and dispose at least a portion of the medical device under a first intermediate diameter, and deploy to a second intermediate restrained configuration to dispose at least a portion of the medical device 104 under a second intermediate diameter.

[0076] As Figure 7B shown, after the removable restraint 226 (or plural restraints as discussed above with reference to Figures 5 - 6 ) is withdrawn, the knot row 130 (or the knot row as discussed above with reference to Figures 5 - 6 ) remains the restraint 102 intact. The knot row 330 is configured to untie to deploy the implantable medical device 110 to a fully deployed configuration (and deploy to a third diameter D3), as Figure 7C shown.

[0077] Figure 8A -C shows illustrations of various stages of deployment of an implantable medical device using the restraint 102 according to one embodiment. The restraint 102 is arranged around the periphery of the implantable medical device 104 ( Figure 8C as shown in) and is configured to releasably restrain the medical device 104 in a restrained configuration as Figure 8A shown. The restrained configuration disposes the medical device under a first diameter D1. The restraint 102 can be any one of the restraints as Figures 3 - 6 shown, and the restraint 102 includes at least one restraint fiber 110 arranged around the periphery of the medical device 104. The (at least one) restraint fiber 110 is intertwined at a first position to form a knot row 330 and a series of plural loops 332 arranged at least partially around the periphery of the medical device 104 from the knot row 330. In some cases, the plural loops 332 can be a second knot row (e.g., each knot row includes a loop 222), as described in more detail above with reference to Figures 3 - 6 .

[0078] The removable restraint 226 is arranged to pass through the plural loops 332 (e.g., the second knot row). The removable restraint 226 is configured to be withdrawn from the plural loops 332 to release the restraint 102 and the implantable medical device 104 to an intermediate configuration. As Figure 7BAs shown, the end portion of the implantable medical device 104 (and the restraint 102) expands to a second diameter D2 in the intermediate configuration. The second diameter D2 is greater than the first diameter D1. In some cases, the restraint fiber 110 or a plurality of restraint fibers are configured to deploy the implantable medical device 104 to a first intermediate restrained configuration, and to dispose the end portion of the medical device under a first intermediate diameter, and to maintain the intermediate portion of the medical device in a restrained configuration (and at diameter D1). The knot row 330 is configured to hold the end portion of the medical device under the first diameter, and a plurality of loops in series are configured to hold the length of the medical device in a restrained configuration.

[0079] As Figure 8B shown, after the removable restraint 226 (or the restraint as discussed above with reference to Figures 5 - 6 is withdrawn, the knot row 130 (or the knot row as discussed above with reference to Figures 5 - 6 holds the restraint 102 intact. The knot row 330 is configured to untie to deploy the implantable medical device 110 to a fully deployed configuration (and to a third diameter D3), as Figure 8C shown.

[0080] 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 disclosure. Accordingly, 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 restraining fiber, the at least one restraining fiber being arranged around the periphery of the medical device to form a restraint that allows for staged deployment of the medical device, and comprising: A series of a plurality of loops, the series of a plurality of loops being intertwined at a first position to form a woven fabric, wherein at least one of the plurality of loops is at least partially arranged around the periphery of the medical device and is joined together at a second position, the woven fabric being configured to separate at the second position to deploy the medical device to at least one intermediate restrained configuration and to separate at the first position to deploy the medical device to a fully deployed configuration, wherein the at least one restraining fiber comprises a plurality of restraining fibers intertwined to form the series of a plurality of loops, and wherein the series of a plurality of loops forms a row of knots at the first position, and the loop-forming portions of the plurality of loops at least partially extend around the periphery of the medical device and are joined together at the second position; A removable restraint, the removable restraint being arranged to pass through the loop-forming portions of the plurality of loops to join the loop-forming portions together at the second position.

2. The apparatus according to claim 1, wherein The removable restraint is configured to be withdrawn from the loop-forming portions of the plurality of loops to deploy the medical device to the at least one intermediate restrained configuration.

3. The device according to claim 1 or 2, characterized in that, The at least one intermediate restrained configuration comprises a first intermediate restrained configuration and a second intermediate restrained configuration, the plurality of restraining fibers being joined at the second position and joined at a third position, and the plurality of restraining fibers being configured to separate at the third position to deploy the medical device to the second intermediate restrained configuration and to separate at the second position to deploy the medical device to the first intermediate restrained configuration.

4. The device according to claim 3, characterized in that Further comprising a second removable restraint, the second removable restraint being configured to join the plurality of restraining fibers at the third position, and wherein the removable restraint is configured to join the plurality of restraining fibers at the second position.

5. The device according to claim 4, characterized in that, The second removable restraint is arranged to pass through the loop-forming portions of the plurality of loops, and the second removable restraint is configured to be withdrawn from the loop-forming portions to separate the plurality of restraining fibers at the third position to deploy the medical device to the second intermediate restrained configuration.

6. The device according to claim 3, wherein The plurality of restraining fibers are configured to deploy to the first intermediate restrained configuration and to arrange at least a portion of the medical device under a first intermediate diameter, and to deploy to a second intermediate restrained configuration to arrange at least a portion of the medical device at a second intermediate diameter.

7. The device according to claim 6, characterized in that, The plurality of restraining fibers are configured to deploy to the first intermediate restrained configuration and to arrange an end portion of the medical device under the first intermediate diameter and to hold an intermediate portion of the medical device in a restrained configuration.

8. The device according to claim 1, characterized in that The removable restraint comprises a pawl.

9. The device according to claim 1, characterized in that, The removable restraint comprises a fiber.

10. A medical device deployment device, the device comprising: Implantable medical device; A restraint, the restraint being disposed around a periphery of the implantable medical device and configured to releasably restrain the implantable medical device in a restrained configuration, the restraint comprising: Restraint fibers disposed around the periphery of the medical device, the restraint fibers being interwoven at a first location to form a row of knots, and a series of multiple loops disposed at least partially around the periphery of the medical device starting from the row of knots; and A removable restraint, the removable restraint being disposed to pass through the multiple loops and configured to be withdrawn from the multiple loops to release the restraint and the implantable medical device to an intermediate configuration, wherein the row of knots is configured to hold at least a portion of the medical device at a first diameter, and the series of multiple loops includes holding the medical device at a second diameter that is less than the first diameter.

11. The device according to claim 10, characterized in that, The row of knots is configured to hold an end portion of the medical device at the first diameter, and the series of multiple loops is configured to hold the length of the medical device in the restrained configuration.

12. The device according to claim 10, characterized in that, The series of multiple loops is disposed around the periphery of the medical device 180 degrees starting from the row of knots, and the first diameter is approximately 50% larger than the second diameter.

13. The device according to claim 10, characterized in that, The row of knots is configured to untie to deploy the implantable medical device to a fully deployed configuration.

Images