Fiber slack reservoir in deployment system handle

Abstract

To provide a method and the like for applying an excellent slack.SOLUTION: According to examples of the present disclosure, a device for storing a slack in a system line 204 for a medical device is disclosed. The device includes a plurality of slack pockets 222 arranged in series. The system line is configured to form a slack loop 224 in each slack pocket, and the plurality of slack pockets separate the slack loops from each other. The plurality of slack pockets are configured to divide slacks by straightening each slack loop from each slack pocket without being entangled with the other slack loop when the tension is applied to the system line.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] Field FIELD OF THE DISCLOSURE The present disclosure relates generally to a system line storage apparatus and, more particularly, to a system line storage apparatus and related methods for delayed actuation during deployment of a medical device. [Background technology]

[0002] background Various medical device delivery systems have multiple actuators that include multiple wires, strings, fibers, or other suitable system lines that control the movement or deployment of one or more components (e.g., a sleeve delivery restraint and / or an expandable implantable device). Delivery systems with multiple actuators are utilized, for example, to ensure that appropriate procedural steps and methods are performed at appropriate operating times, rather than multiple steps being performed simultaneously or without an appropriate amount of delay between steps. However, among other problems, systems with multiple actuators can be relatively complex, require larger handles and / or thicker catheters to accommodate the additional system lines, and can increase the risk of malfunction due to tangling, knotting, or interference with the system lines. Summary of the Invention

[0003] Abstract According to one example ("Example 1") of the present disclosure, a slack storage system for a system line in a medical device is disclosed. The slack storage system includes a plurality of slack pockets arranged in series and a system line having a first end and a second end, where a portion of the system line between the first end and the second end defines a slack loop within each slack pocket, and the plurality of slack pockets separate the plurality of slack loops from one another to define slack in the system line such that when tension is applied to the first end of the system line, the second end of the system line remains untensioned without entangling with another of the slack loops, when distributing slack in the system line by straightening each slack loop from each slack pocket.

[0004] Referring to Example 1, each of the plurality of slack pockets can be sized and shaped such that a slack loop can be formed by forcing the system line into the slack pocket with a finger-shaped element. Each of the slack loops can be approximately the same length. Each of the plurality of slack pockets can be approximately the same size and shape. Each of the plurality of slack pockets can be equally spaced from one another. Each of the plurality of slack pockets can extend in a common direction. Each of the plurality of slack pockets can include a retainer configured to releasably hold a respective one of the slack loops in the slack pocket in which the slack loop is formed. When the slack pocket includes a retainer, the retainer can include any of an adhesive, a mechanical fastener, a bond, and combinations thereof.

[0005] With further reference to Example 1, at least one slack loop can be formed in at least one slack pocket with finger elements configured to insert one or more portions of the system line into the series of slack pockets. At least one additional loop can be formed in the at least one additional slack pocket. Multiple slack loops can be formed simultaneously. A size of the at least one slack loop can be adjusted to vary the amount of slack stored. Assembly validation can be provided by feedback when improper tension is detected during formation of the slack loop.

[0006] According to another example ("Example 2") of the present disclosure, a method for providing slack in a system line for a medical device is disclosed, the method including: disposing the system line adjacent to a series of slack pockets of a slack storage system; and disposing at least one of a plurality of portions of the system line in at least one of the series of slack pockets of the slack storage system to form at least one slack loop, where the slack loop stores slack in the system line between a first end of the system line and a second end of the system line.

[0007] Referring to Example 2, at least one slack loop may be formed in at least one slack pocket with a finger element configured to insert one or more portions of the system line into the series of slack pockets. The method may further include forming at least one additional slack loop in at least one additional slack pocket. Multiple slack loops may be formed simultaneously. The method may further include adjusting a size of at least one slack loop to vary an amount of slack stored. The method may further include providing assembly validation by feedback when improper tension is detected during slack loop formation.

[0008] Still referring to Example 2, each of the plurality of slack pockets can be sized and shaped such that a slack loop can be formed by forcing the system line into the slack pocket with a finger element. Each of the slack loops can be approximately the same length. Each of the plurality of slack pockets can be approximately the same size and shape. The plurality of slack pockets can be equally spaced apart from one another. Each of the plurality of slack pockets can extend in a common direction. Each of the plurality of slack pockets can include a retainer configured to releasably hold a respective one of the slack loops in the slack pocket in which the slack loop is formed. When the slack pocket includes a retainer, the retainer can include any of an adhesive, a mechanical fastener, a bond, and combinations thereof.

[0009] According to yet another example of the present disclosure ("Example 3"), an apparatus for storing slack in a system line is disclosed that includes a plurality of slack pockets arranged in series, where the system line is configured to form a slack loop within each slack pocket, the plurality of slack pockets separating the slack loops from one another, and the plurality of slack pockets configured to distribute slack by straightening each slack loop from each slack pocket without entangling with another slack loop when tension is applied to the system line.

[0010] With reference to Example 3, at least one slack loop can be formed in at least one slack pocket with finger elements configured to insert one or more portions of the system line into the series of slack pockets. At least one additional slack loop can be formed in the at least one additional slack pocket. Multiple slack loops can be formed simultaneously. A size of the at least one slack loop can be adjusted to vary the amount of slack stored. Assembly validation can be provided by feedback when improper tension is detected during formation of the slack loop.

[0011] Further referring to Example 3, each of the plurality of slack pockets can be sized and shaped such that a slack loop can be formed by forcing the system line into the slack pocket with a finger element. Each of the slack loops can be approximately the same length. Each of the plurality of slack pockets can be approximately the same size and shape. The plurality of slack pockets can be equally spaced apart from one another. Each of the plurality of slack pockets can extend in a common direction. Each of the plurality of slack pockets can include a retainer configured to releasably hold a respective one of the slack loops in the slack pocket in which the slack loop is formed. When the slack pocket includes a retainer, the retainer can include any of an adhesive, a mechanical fastener, a bond, and combinations thereof.

[0012] According to another example of the present disclosure ("Example 4"), a method for providing slack to a system line is disclosed, the method including: positioning a system line adjacent to a series of slack pockets of a slack storage system; and positioning at least one of a plurality of portions of the system line in at least one of the series of slack pockets of the slack storage system to form at least one slack loop, the slack loop storing slack in the system line between a first end of the system line and a second end of the system line, where at least a portion of the system line is positioned in the at least one slack pocket with a finger element.

[0013] Referring to Example 4, at least one slack loop may be formed in at least one slack pocket with a finger element configured to insert one or more portions of the system line into the series of slack pockets. The method may further include forming at least one additional slack loop in at least one additional slack pocket. Multiple slack loops may be formed simultaneously. The method may further include adjusting a size of at least one slack loop to vary an amount of slack stored. The method may further include providing assembly validation by feedback when improper tension is detected during slack loop formation.

[0014] Further referring to Example 4, each of the plurality of slack pockets can be sized and shaped such that a slack loop can be formed by forcing the system line into the slack pocket with a finger-shaped element. Each of the slack loops can be approximately the same length. Each of the plurality of slack pockets can be approximately the same size and shape. The plurality of slack pockets can be equally spaced apart from one another. Each of the plurality of slack pockets can extend in a common direction. Each of the plurality of slack pockets can include a retainer configured to releasably hold a respective one of the slack loops within the slack pocket in which the slack loop is formed. When the slack pocket includes a retainer, the retainer can include any of an adhesive, a mechanical fastener, a bond, and combinations thereof.

[0015] According to yet another example of the present disclosure ("Example 5"), an apparatus for storing slack in a system line for a medical device is disclosed, the apparatus including a plurality of slack pockets arranged in series and a system line forming a slack loop within each slack pocket, the plurality of slack pockets separating the slack loops from one another, the plurality of slack pockets configured such that when tension is applied to the system line, slack is distributed by straightening each slack loop from each slack pocket without entangling with another one of the slack loops.

[0016] Referring to Example 5, at least one slack loop can be formed in at least one slack pocket with finger elements configured to insert one or more portions of the system line into the series of slack pockets. At least one additional slack loop can be formed in the at least one additional slack pocket. Multiple slack loops can be formed simultaneously. A size of the at least one slack loop can be adjusted to vary the amount of slack stored. Assembly validation can be provided by feedback when improper tension is detected during slack loop formation.

[0017] Further referring to Example 5, each of the plurality of slack pockets can be sized and shaped such that a slack loop can be formed by forcing the system line into the slack pocket with a finger-shaped element. Each of the slack loops can be approximately the same length. Each of the plurality of slack pockets can be approximately the same size and shape. The plurality of slack pockets can be equally spaced apart from one another. Each of the plurality of slack pockets can extend in a common direction. Each of the plurality of slack pockets can include a retainer configured to releasably hold a respective one of the slack loops in the slack pocket in which the slack loop is formed. When the slack pocket includes a retainer, the retainer can include any of an adhesive, a mechanical fastener, a bond, and combinations thereof.

[0018] According to another example of the present disclosure ("Example 6"), an apparatus for storing slack in a system line is disclosed, the apparatus including a plurality of slack pockets arranged in series and a system line forming a slack loop within each slack pocket, the plurality of slack pockets separating the slack loops from one another, and the plurality of slack pockets configured to distribute slack by straightening each slack loop from each slack pocket without entangling with another slack loop when tension is applied to the system line.

[0019] With reference to Example 6, at least one slack loop can be formed in at least one slack pocket with finger elements configured to insert one or more portions of the system line into the series of slack pockets. At least one additional slack loop can be formed in the at least one additional slack pocket. Multiple slack loops can be formed simultaneously. A size of the at least one slack loop can be adjusted to vary the amount of slack stored. Assembly validation can be provided by feedback when improper tension is detected during formation of the slack loop.

[0020] Further referring to Example 6, each of the plurality of slack pockets can be sized and shaped such that a slack loop can be formed by forcing the system line into the slack pocket with a finger element. Each of the slack loops can be approximately the same length. Each of the plurality of slack pockets can be approximately the same size and shape. The plurality of slack pockets can be equally spaced apart from one another. Each of the plurality of slack pockets can extend in a common direction. Each of the plurality of slack pockets can include a retainer configured to releasably hold a respective one of the slack loops in the slack pocket in which the slack loop is formed. When the slack pocket includes a retainer, the retainer can include any of an adhesive, a mechanical fastener, a bond, and combinations thereof.

[0021] According to yet another example ("Example 7") of the present disclosure, a method for operating an apparatus for storing slack in a system line for a medical device is disclosed, the method including: positioning the system line adjacent to a series of slack pockets of a slack storage system, positioning a portion of the system line in each of the series of slack pockets to form a slack loop in each of the series of slack pockets, where the slack loop stores slack in the system line between a first end of the system line and a second end of the system line, and applying tension to the system line such that each slack loop is released from a respective slack pocket.

[0022] Referring to Example 7, at least one slack loop may be formed in at least one slack pocket with a finger element configured to insert one or more portions of the system line into the series of slack pockets. The method may further include forming at least one additional slack loop in at least one additional slack pocket. Multiple slack loops may be formed simultaneously. The method may further include adjusting a size of at least one slack loop to vary the amount of slack stored. The method may further include providing assembly validation by feedback when improper tension is detected during slack loop formation.

[0023] Still referring to Example 7, each of the plurality of slack pockets can be sized and shaped such that a slack loop can be formed by forcing the system line into the slack pocket with a finger-shaped element. Each of the slack loops can be approximately the same length. Each of the plurality of slack pockets can be approximately the same size and shape. The plurality of slack pockets can be equally spaced apart from one another. Each of the plurality of slack pockets can extend in a common direction. Each of the plurality of slack pockets can include a retainer configured to releasably hold a respective one of the slack loops in the slack pocket in which the slack loop is formed. When the slack pocket includes a retainer, the retainer can include any of an adhesive, a mechanical fastener, a bond, and combinations thereof.

[0024] According to another example of the present disclosure ("Example 8"), a method for operating an apparatus for storing slack in a system line is disclosed that includes: positioning a system line adjacent to a series of slack pockets of a slack storage system, positioning a portion of the system line in each of the series of slack pockets to form a slack loop in each of the series of slack pockets, where the slack loop stores slack in the system line between a first end of the system line and a second end of the system line, and applying tension to the system line such that each slack loop is released from a respective slack pocket.

[0025] Referring to Example 8, at least one slack loop may be formed in at least one slack pocket with a finger element configured to insert one or more portions of the system line into the series of slack pockets. The method may further include forming at least one additional slack loop in at least one additional slack pocket. Multiple slack loops may be formed simultaneously. The method may further include adjusting a size of at least one slack loop to vary an amount of slack stored. The method may further include providing assembly verification by feedback when improper tension is detected during slack loop formation.

[0026] Further referring to Example 8, each of the plurality of slack pockets can be sized and shaped such that a slack loop can be formed by forcing the system line into the slack pocket with a finger-shaped element. Each of the slack loops can be approximately the same length. Each of the plurality of slack pockets can be approximately the same size and shape. The plurality of slack pockets can be equally spaced apart from one another. Each of the plurality of slack pockets can extend in a common direction. Each of the plurality of slack pockets can include a retainer configured to releasably hold a respective one of the slack loops in the slack pocket in which the slack loop is formed. When the slack pocket includes a retainer, the retainer can include any of an adhesive, a mechanical fastener, a bond, and combinations thereof.

[0027] The foregoing examples are merely illustrative and should not be read to limit or otherwise narrow the scope of any of the inventive concepts 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 should be regarded as illustrative in nature and not as restrictive in nature. [Brief description of the drawings]

[0028] 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.

[0029] [Figure 1] FIG. 1 is a schematic diagram of a medical device deployment system, according to some embodiments.

[0030] [Diagram 2] FIG. 2 is another schematic diagram of a medical device deployment system, according to some embodiments.

[0031] [Diagram 3] FIG. 3 is a cross-sectional view of a portion of a handle including a system line storage system, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] Detailed Description Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0033] Definitions and Terminology With respect to the term imprecision, the terms "about" and "approximately" may be used interchangeably to refer to measurements that include the stated measurement and also include measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount, as would be understood and readily ascertained by one of ordinary skill in the relevant art. Such deviations may be due, for example, to measurement error or fine-tuning made to optimize performance. In cases where it is determined that such reasonably small difference values ​​would not be readily ascertainable by one of ordinary skill in the relevant art, the terms "about" and "approximately" may be understood to mean ±10% of the stated value.

[0034] Medical devices are frequently used to treat the vasculature of human patients. These treatments or procedures are commonly referred to as intraluminal or intravascular procedures. Such devices often include a sleeve. As used herein, the term "sleeve" refers to a primary, secondary, tertiary, etc., sleeve, sheath, etc. that covers, surrounds, or is otherwise associated with a medical device. In some instances, such a "sleeve" constrains the medical device to a collapsed configuration or circumferential dimension suitable for medical delivery of the device to a treatment portion of the patient's vasculature.

[0035] For purposes of this disclosure, the term "constrain" can mean (i) limiting the expansion of the diameter of a medical device, either self-expanding or device-assisted, or (ii) covering or surrounding or in a manner that restrains a medical device (e.g., for storage or biocompatibility reasons, and / or for reasons of protecting the medical device and / or vasculature).

[0036] As used herein, the term "medical device" or "device" refers to stents, grafts, filters, valves, anchors, occluders and other devices including other implantable devices, including all of the foregoing constrained by one or more restraints or sleeves.

[0037] As used herein, the term "line" refers to any type of string, cord, thread, fiber or wire and can include metallic, polymeric or natural materials, including conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethyl methacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, stainless steel, cobalt chromium alloys, metals such as Nitinol, high strength polymeric fibers such as ultra high molecular weight polyethylene fibers or aramid fibers.

[0038] This disclosure is not intended to be read in a restrictive manner, for example, the terms used in this application should be read broadly with respect to the meaning ascribed to such terms in the art.

[0039] Description of the Disclosed Embodiments Various examples relate to timing (e.g., delaying) operation of system lines of a delivery system according to a predetermined sequence of operations that can be associated with one or more delivery operations of a medical device. Suitable delivery operations controlled by system lines include removal or actuation of sleeves, delivery restraints, steering functions of the delivery system, etc.

[0040] In various embodiments, the delivery system includes a sleeve or restraint (e.g., a sleeve, fabric, or other feature) for releasably restraining a medical device (e.g., a vascular implant such as a stent or stent graft) for delivery to a target site within the body. Such a restraint can have a first state that releasably restrains the expandable implant toward a delivery configuration suitable for medical delivery, and a second state that allows the medical device an amount of expansion (e.g., partial expansion or full expansion) from the delivery configuration toward a deployed configuration. The deployment system can include a handle with an actuation mechanism configured to actuate the sleeve or restraint via tension in an associated system line. Alternatively or additionally, the delivery system can include an actuation mechanism configured to actuate a medical steering maneuver upon actuation of the actuation mechanism via the system line.

[0041] In some instances, the system lines manipulate a sleeve or restraint, such as a sleeve or loop, that releasably restrains the implantable device in a diametrically compressed configuration. In some instances, the restraint comprises a sleeve (e.g., made of a film material) that extends or wraps around a medical device, such as an implant (e.g., a stent, stent graft, artificial valve, or other endoprosthesis).

[0042] In instances where the system line is operably coupled to the restraint, the restraint may define two states: a first actuated state and a second released state. In the first state, the restraint, such as a sleeve, may have opposing portions or edges that are releasably held or sewn together, such as a wire or fabric, to maintain the medical device in a delivery configuration. The wire or fabric may form part of the system line or may be a separate component operably coupled to the system line. In such embodiments, the restraint may be opened or otherwise broken by retracting, unstitching or otherwise disconnecting the system line from the restraint to allow expansion of the medical device. Such release may occur by actuation of an actuation mechanism as described above. Further details of such restraining sleeves may be found, for example, in U.S. Patent No. 6,352,561 to Leopold et al. and U.S. Patent No. 6,551,350 to Thornton et al. Other examples of suitable restraints include a sleeve that is retracted or pulled proximally toward the rear end of the medical device to release the medical device. Yet other examples of suitable restraints include fibers or tethers that can be looped around the medical device and tensioned and / or released to restrain and unrestrain or release the medical device. Still other examples of restraints include knitted sleeves that unravel when tensioned, such as those described in U.S. Patent No. 6,224,627 to Armstrong et al.

[0043] Regardless of the restraint used, in various instances, tension in the system lines releases the restraint so that the associated medical device can self-expand or expand according to the desired delivery method of the medical device.

[0044] The timing or sequence of operations for actuation of the system lines and associated restraint releases can be controlled by incorporating slack devices to help ensure that the deployment process occurs at a given time in the sequence (e.g., after some pre-determined delay). For example, a delay can be employed to allow other actuation or delivery operations (e.g., another sleeve release, partial deployment, steering operation) to occur before the system lines actuate the associated components (e.g., restraints). Examples of suitable steering features can be found in U.S. Patent No. 9,375,308 to Norris.

[0045] 1 is a generalized schematic diagram of a medical device deployment system 100 including a system line storage device 102. The medical device deployment system 100 includes a first actuation mechanism A1, a second actuation mechanism A2, a first system line 104, and a second system line 106.

[0046] The medical device deployment system 100 can be utilized to implement a method that includes a set of operations or operation elements. In some examples, the deployment system 100 is configured to include at least two operations or operation elements, a first operation and a second operation, each of which is an element of a delivery operation associated with the system 100. In various examples, the first system line 104 is actuable via a first actuation mechanism A1 to initiate a first operating element (e.g., actuation of a sleeve or release of a first restraint) and the second system line 106 is actuable via a second actuation mechanism A2 to initiate a second operating element (e.g., actuation of a sleeve or release of a second restraint).

[0047] FIG. 2 is another generalized schematic diagram of the deployment system 100, according to some examples. As shown in FIG. 2, the first and second actuation mechanisms A1 and A2 can be part of a handle, such as an actuation handle 108. The actuation handle 108 can take any of a variety of shapes and sizes and is generally configured to be gripped by a user. The actuation mechanisms A1, A2 of FIG. 1 can be embodied in a variety of forms. For example, the actuation mechanisms can be buttons, toggles, switches, dials, rotatable cuffs, or other actuators that can cause actuation of the first and second system lines 104 and 106, respectively, for example, by applying tension to the first and second system lines 104 and 106, respectively. The first and second actuation mechanisms A1 and A2 can be a single component. For example, the first and second actuation mechanisms A1 and A2 can be part of a single button, toggle, switch, dial, rotatable cuff, or other actuation mechanism that is coupled to both the first and second system lines 104 and 106 but can function as the first actuation mechanism A1 of the first system line 104 and as the second actuation mechanism A2 of the second system line 106.

[0048] Generally, the first actuation mechanism A1 operates to steer, e.g., apply tension to, the first system line 104 which operates or actuates a first operating element of the system 100. For example, the first operating element of the system 100 can be the retraction of an outer sleeve 111 (e.g., a first constraining sleeve) that covers the medical device and maintains a portion of the medical device at a constrained diameter.

[0049] The second actuation mechanism A2 then manipulates the second system line 106 to steer, e.g., apply tension to the second system line 106, to manipulate or actuate a second operating element of the system 100. By way of example, the second operating element can be the longitudinal displacement of a restraining sleeve (e.g., a second restraining sleeve) on an expandable medical device (e.g., a stent, stent graft, filter, prosthetic valve, occluder, anastomosis device), such as the restraining sleeve 110 and medical device 112 shown in FIG.

[0050] The first system line 104 passes through a system line storage device 102 which holds a desired length or portion of the first system line 104. This length or stored portion of the first system line 104 can function as a timing or delay mechanism such that the system line 104 is taut and a desired amount of slack or stored material in the system line 104 is pulled, absorbed or consumed before the system line 104 is pulled taut and a second end of the system line 104 beyond the system line storage device 102 is actuated or tensioned to function the first operating element.

[0051] In some examples, and as generally shown in FIG. 1, the system 100 may also include a second system line storage device 114. In such a configuration, both system lines 104, 106 may be configured to provide various amounts of delay to the operational elements as desired. In other words, the system line storage device 102 may include a first system line storage device 102, a second system line storage device 114, or multiple system line storage devices, depending on the operational elements and / or the amount of delay desired in the system 100. Although two system lines and one or two storage systems have been described and illustrated, it should be apparent from the above that any number and combination of system lines and storage systems may be used depending on the complexity of the delivery system.

[0052] As shown in the schematic diagram of FIG. 2, the delivery system 100 can include a catheter body 116, a medical device 112, a first restraint 110 that restrains a first portion of the medical device 112 in a delivery configuration, a second restraint 111 that restrains a second portion of the medical device 112 in a delivery configuration, an actuation mechanism 120 associated with the handle 108, a first system line 104 configured to assist in performing various operational elements of the delivery system 100 (e.g., retracting or releasing the second restraint 111), and a system line storage device 102 associated with the delivery system 100 (e.g., housed within or otherwise coupled to the catheter body 116 and / or handle 108).

[0053] 3 provides a detailed cross-sectional view of an example of the handle 108 and the system line storage device 102. For reference, the system line storage device 114, as well as any number of the system line storage devices included in the delivery system 100, can be similar in shape and configuration to the storage device 102.

[0054] As shown in the example of FIG. 3, the system line storage device 102 is embodied as a device 208 of the delivery system 200 (shown housed within the handle of the delivery system 200). The system line storage device 208 includes a body 220 defining a plurality of slack pockets 222 arranged in series within the body 220. Illustratively, the plurality of slack pockets 222 are approximately the same shape and size. In other embodiments, the slack pockets 222 can vary in shape and / or size relative to one another depending on the desires of a user or the requirements of the delivery system 200. For example, in another embodiment of the system line storage device 208 not shown in isolation, the size and shape of the slack pockets can be altered (e.g., shape, spacing, orientation, etc.) to accommodate the needs of a particular system. As shown, in some examples, the slack pockets 222 each include a neck 223 at the opening of the slack pocket 222, which can vary in width depending on the total delay length desired and the overall space available within the handle of the delivery system 200.

[0055] Generally, the slack pockets 222 are configured (e.g., sized and shaped) to releasably retain (e.g., by friction, whether or not assisted by a secondary retention means such as a releasable adhesive or a mechanical retainer) the system line 204 until sufficient tension is applied to the system line 204 to retract the system line 204 from the slack pockets 222. The system line storage device may further include one or more retainers configured to retain the slack loops 224 within the slack pockets 222 in which the slack loops 224 are defined. Suitable retainers may include adhesives, mechanical fasteners, the like, and combinations thereof.

[0056] Additional retainers may also be utilized to facilitate control of the system lines 204. For example, in an exemplary embodiment, the delivery system 200 includes a series of covers 225, each corresponding to a slack pocket 222. Each cover 225 aids in retaining the system lines 204 between the slack pockets 222 and includes a complete hole to allow access to the system lines 204 so that the system lines 204 can be manipulated to form slack loops 224 within the slack pockets 222. Standing posts 227 are positioned at either or both ends of the series of slack pockets 222 to allow for directing the fiber through the delivery system 200. The standing posts 227 facilitate alignment of the fiber with the center of the narrowest portion of the slack pocket when tension is applied to the fiber during assembly, so that the fiber can be consistently pushed down into the slack pockets 222 to a predetermined depth.

[0057] In some examples, a press element (e.g., a finger-shaped element or simply a user's finger) can be implemented to push, press, or otherwise insert the system line 204 into each slack pocket 222 to form multiple slack loops 224, where each slack loop 224 is formed within each pocket 222. For example, the slack pocket 222 is sized and shaped to receive the press element, and the press element is used to place the system line 204 within the slack pocket 222 to hold a given length of the system line 204 as storage slack or excess length to be wound up during tensioning. For example, as the system line 204 passes through the handle 208, the system line 204 passes through multiple openings and enters the slack pocket 222. The press element can be used to press the system line 204 in a direction corresponding to the direction in which the slack pocket 222 extends. As shown, the slack pocket 222 is oriented in a direction that is substantially perpendicular or perpendicular to the direction in which the system line 204 is actuated or tensioned / pulled. The portion of the system line 204 engaged by the press element is deposited within the slack pocket 222. Once the corresponding portion of the system line 204 has been inserted into the slack pocket 222, the press element can be removed from the slack pocket 222 leaving the formed slack loop 224 within the slack pocket 222.

[0058] As alluded to above, the press element used to insert the system line 204 into the pockets 222 is movable such that the slack loops 224 can be formed in-line. For example, the press element can be used to insert a first portion of the system line 204 into the first slack pocket 222 to form the first slack loop 224. The press element can also be moved to a position above a second portion of the system line 204 aligned with the second slack pocket 222 to insert the second portion of the system line 204 into the second slack pocket 222 to form the second slack loop 224. By repeating this motion, the press element moves along different portions of the system line 204 corresponding to each slack pocket 222 until each slack pocket 222 is filled.

[0059] The press element may include a mechanical finger, such as a probe, rod, or other instrument, or in other embodiments, a user may use the user's finger to insert the system line 204 into the slack pocket 222. In some embodiments, the handle 208 may include multiple press elements for simultaneously forming one or more slack loops 224 in the slack pockets 222. For example, in a delivery system 220 having a set number of slack pockets "X", the delivery system may also have "X" press elements, one for each corresponding slack pocket 222. The delivery system line 220 may have a number of press elements that is less than the number of slack pockets 222 included in the delivery system 220.

[0060] Once the slack loops 224 are formed, each slack loop 224 can be adjusted individually or collectively to change the amount of slack stored in each slack pocket. Verification of the proper amount of slack can be detected by visual inspection or other feedback after attempting to insert the system line 204 into a given slack pocket 222. For example, if tension above or below a desired level is detected during testing of the slack loops 224, the process can be deemed defective and started over.

[0061] When a desired amount of tension is applied to the system line 204, the slack created by the slack loops 224 is released from each slack pocket 222 via the slack loops 224. Tension is applied to the system line 204 in a direction that is substantially perpendicular or orthogonal to the direction in which the slack pockets 222, and therefore the slack loops 224, extend. This causes each slack loop 224 to be approximately straight when released, released, or otherwise removed from the corresponding slack pocket 222. Releasing the slack loops 224 in series reduces the likelihood that the system line 204 will tangle with itself or with other system components as the slack in the system line 204 is released. The slack pockets 222 may be utilized to separate the slack loops 224 from one another, thereby reducing the chance of the slack loops 224 tangling with one another, meaning that each slack loop 224 is released and straightens out in series, preventing a released slack loop 224 from contacting another released slack loop 224 before or after the slack loop is released. The slack pockets 222 may extend in a common direction and / or be evenly spaced from one another to facilitate such release without tangling the slack loops 224.

[0062] In some embodiments, the slack pockets 222 can extend in alternating directions or have different arrangements, depending on the needs of the user and the design of the delivery system, without compromising their functionality. Similarly, in some embodiments, the slack pockets 222 may not be equally spaced, depending on the needs of the user and the design of the delivery system. The slack pockets 222 may be arranged in a linear arrangement as shown (e.g., along a common line), or in other configurations, such as an alternating zigzag pattern or other arrangements, as desired. As referenced, the number and depth of the slack pockets 222 may vary, depending on the needs of the user and the design of the delivery system. For example, the number of slack pockets 222, the depth of the slack pockets 222, and the size of the overall assembly may vary to accommodate a longer system line 204 and / or a greater amount of slack incorporated into the system line 204.

[0063] Although the exemplary embodiment includes a system line for use with an implantable medical device, in other embodiments, the slack storage system 220 can be utilized with other system lines associated with other medical devices, such as a suturing system where the system line is a suture, or in any application where storage of lengths of the system line is required to avoid tangling when the slack of the system line is dispensed. In other words, the invention of the present application has been described above both generally and with reference to specific embodiments. It will be apparent to one skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the present disclosure. Accordingly, the embodiments are intended to cover modifications and variations of the present invention provided they come within the scope of the appended claims and their equivalents. (Aspect 1) 1. A slack storage system for a system line in a medical device, the slack storage system comprising: A plurality of slack pockets arranged in series; and a system line having a first end and a second end; Including, wherein a portion of the system line between the first end and the second end defines a slack loop within each slack pocket; the plurality of slack pockets separate the plurality of slack loops from one another to define slack in the system line such that when a first end of the system line is pulled, slack in the system line is distributed by allowing each slack loop to straighten out from each slack pocket without entangling with another of the slack loops, leaving a second end of the system line untensioned. (Aspect 2) 2. The apparatus of claim 1, wherein each of the plurality of slack pockets is sized and shaped such that the slack loop can be formed by forcing the system line into the slack pocket with a finger-shaped element. (Aspect 3) 3. The apparatus of claim 1 or 2, wherein each of the slack loops is approximately the same length. (Aspect 4) 20. The apparatus of any one of the preceding aspects, wherein each of the plurality of slack pockets is approximately the same size and shape. (Aspect 5) The apparatus of any one of the preceding aspects, wherein the plurality of slack pockets are equally spaced apart from one another. (Aspect 6) The apparatus of any one of the preceding aspects, wherein each of the plurality of slack pockets extends in a common direction. (Aspect 7) The apparatus of any one of the preceding aspects, wherein each of the plurality of slack pockets includes a retainer configured to releasably hold a respective one of the slack loops in the slack pocket in which the slack loop is formed. (Aspect 8) 8. The apparatus of embodiment 7, wherein the retainer comprises any of an adhesive, a mechanical fastener, a bond, and combinations thereof. (Aspect 9) 1. A method for providing slack in a system line for a medical device, comprising: positioning a system line adjacent to a series of slack pockets of a slack storage system; and placing at least one of a plurality of portions of said system line into at least one of a series of slack pockets of said slack storage system to form at least one slack loop; Including, wherein the slack loop stores slack in the system line between a first end of the system line and a second end of the system line. (Aspect 10) 10. The method of claim 9, wherein the at least one slack loop is formed in at least one slack pocket with a finger-shaped element configured to insert one or more portions of the system line into the series of slack pockets. (Aspect 11) 10. The method of embodiment 9, further comprising forming at least one additional slack loop in the at least one additional slack pocket. (Aspect 12) The method of embodiment 9, wherein multiple slack loops are formed simultaneously. (Aspect 13) The method of any one of embodiments 9-12, further comprising adjusting a size of the at least one slack loop to vary the amount of slack stored. (Aspect 14) The method of any one of embodiments 9-13, further comprising providing assembly validation by feedback when inadequate tension is detected during slack loop formation. (Aspect 15) 1. An apparatus for storing slack in a system line, comprising: Multiple slack pockets arranged in series, Including, wherein the system lines are configured to form a slack loop within each slack pocket, and the plurality of slack pockets separate the slack loops from one another; The apparatus, wherein the plurality of slack pockets are configured to distribute slack by straightening each slack loop from each slack pocket without entangling with another slack loop when tension is applied to the system line. (Aspect 16) 1. A method for providing slack to a system line, comprising: positioning the system line adjacent to a series of slack pockets of the slack storage system; placing at least one of a plurality of portions of said system line into at least one of a series of slack pockets of said slack storage system to form at least one slack loop; Including, wherein the slack loop stores slack in the system line between a first end of the system line and a second end of the system line; The method, wherein at least a portion of the system line is disposed in at least one slack pocket with a finger element. (Aspect 17) 1. An apparatus for storing slack in a system line for a medical device, comprising: A plurality of slack pockets arranged in series; and System lines that form slack loops within each slack pocket, Including, wherein the plurality of slack pockets separate the slack loops from one another; The apparatus, wherein the plurality of slack pockets are configured to distribute slack by straightening each slack loop from each slack pocket without entangling with another of the slack loops when tension is applied to the system line. (Aspect 18) 1. An apparatus for storing slack in a system line, comprising: A plurality of slack pockets arranged in series; and System lines that form slack loops within each slack pocket, Including, wherein the plurality of slack pockets separate the slack loops from one another; The apparatus, wherein the plurality of slack pockets are configured to distribute slack by straightening each slack loop from each slack pocket without entangling with another slack loop when tension is applied to the system line. (Aspect 19) 1. A method for operating an apparatus for storing slack in a system line for a medical device, comprising: positioning the system line adjacent to a series of slack pockets of the slack storage system; placing a portion of the system line in each of a series of slack pockets to form a slack loop in each of the series of slack pockets; and applying tension to said system line such that each of the slack loops is released from each of the slack pockets; Including, wherein the slack loop stores slack in the system line between a first end of the system line and a second end of the system line. (Aspect 20) 1. A method for operating an apparatus for storing slack in a system line, comprising: positioning the system line adjacent to a series of slack pockets of the slack storage system; placing a portion of the system line into each of the series of slack pockets to form a slack loop in each of the series of slack pockets; and applying tension to said system line such that each of the slack loops is released from each of the slack pockets; Including, wherein the slack loop stores slack in the system line between a first end of the system line and a second end of the system line.

Claims

1. 1. A method for providing slack to a system line, comprising: positioning the system line adjacent to a series of slack pockets of the slack storage system; placing at least one of a plurality of portions of said system line into at least one of a series of slack pockets of said slack storage system to form at least one slack loop; Including, wherein the slack loop stores slack in the system line between a first end of the system line and a second end of the system line; The method, wherein at least a portion of the system line is disposed in at least one slack pocket with a finger element.

2. 1. A method for providing slack in a system line for a medical device, comprising: placing at least one of the plurality of portions of the system line into at least one of a series of slack pockets of a slack storage system to form at least one slack loop; and providing assembly validation by feedback when improper tension is detected during slack loop formation; Including, wherein the slack loop stores slack in the system line between a first end of the system line and a second end of the system line.

3. The method of any one of claims 1 to 2, further comprising forming at least one additional slack loop in the at least one additional slack pocket.

4. The method of any one of claims 1 to 3, wherein each slack loop of the plurality of slack loops is formed simultaneously.

5. The method of any one of claims 1 to 4, further comprising forming a plurality of slack loops, each of said slack loops being approximately the same length.

6. The method of any one of claims 1 to 5, wherein each of the plurality of slack pockets is approximately the same size and shape.

7. The method of any one of claims 1 to 6, wherein each of the plurality of slack pockets is equally spaced from an adjacent slack pocket.

8. The method of any one of claims 1 to 7, wherein each of the plurality of slack pockets extends in a common direction.

9. The method of any one of claims 1 to 8, wherein each of the slack pockets includes a retainer configured to releasably retain a respective one of the slack loops within the slack pocket in which the slack loop is formed.

10. The method of claim 9 , wherein the retainer comprises any one of an adhesive, a mechanical fastener, a bond, and combinations thereof.

11. 1. A method for providing slack in a system line for a medical device, comprising: positioning the system line adjacent to a series of slack pockets of the slack storage system; placing a plurality of portions of the system line into a series of slack pockets of the slack storage system to simultaneously form a plurality of slack loops; and adjusting a size of at least one slack loop of the plurality of slack loops to vary an amount of stored slack; Including, 11. The method of claim 10, wherein each slack loop of the plurality of slack loops stores slack in the system line between a first end of the system line and a second end of the system line.

Images