WO2019055433A1 - Suture tensioning device - Google Patents

Abstract

Suture tensioning devices can improve the ease for a user and/or success of typing a suture knot. The suture tensioning device can be held by a user or attached to a separate device, such as a device being used for the knot forming. Embodiments of the suture tensioning devices described herein can generally include a rotatable portion and a tensioning portion. One or more sutures can be configured to be loaded on the rotatable portion. The tensioning portion can have a spring operably connected to the rotatable portion. The tensioning portion can be configured to provide a predetermined amount of tension on the one or more sutures when the rotatable portion is rotated in one or more directions.

Description

SUTURE TENSIONING DEVICE

INCORPORATION BY REFERENCE

[0001] This application claims the priority benefit of U.S. Provisional Application No. 62/557,401, filed September 12, 2017, the entirety of which is incorporated herein by reference in their entirety.

FIELD

[0002] The present disclosure relates to a suture tensioning device, and more specifically, to a suture tensioning device that can maintain a desired amount of tension on a suture or sutures at any point in a suturing procedure, including a knot-forming procedure performed at the end of the suturing.

SUMMARY

[0003] When applying a knot to one or more sutures such as described above, the suture portions need to be tensioned to pull one or more tissues together for closure of an opening. Thus, properly tensioning the suture portions can allow a firm knot to be applied to close an opening in a tissue, and/or suturing a plurality of tissues closer together. However, pulling the suture portions too tight can be undesirable, as it can result in rupturing of the suture portions or damaging the surrounding tissue. For example, when applying a knot to suture portions that apply too much tension on the apex of the heart, an accelerated heart beat can push the sutures against the myocardium until the sutures rupture. In addition, having too little tension (e.g., loose sutures) can lead to improper closure of the tissue. Accordingly, it can be advantageous for the suture portions to remain at a particular tension throughout a suturing and/or knot forming procedure.

[0004] Previously, when applying a knot to suture portions, a user would typically tension the suture portions by hand. Problems with tensioning the suture portions in a free hand manner can include difficulty of applying the desired amount of tension, maintaining a substantially constant amount of tension in the suture(s) at any stage of the procedure (e.g., when a knot forming device such as described above is advanced toward a suturing location), and/or requiring the user to hold the suture with at least one hand during the knot-forming procedure thus depriving the user of the use of one of the hands to complete the suturing procedure. Additionally, the amount of tensioning in the suture portions depends on, for example, the user's skills and/or experience in tensioning the suture portions by hand and thus can be subjected to the individual user, leading to improper suturing.

[0005] Some embodiments of the suture tensioning device described herein can solve one or more of the problems described above, and/or other problems. The suture tensioning device can be held by a user or attached to a separate device, such as a device being used for the knot forming. Embodiments of the suture tensioning device described herein can generally include a rotatable portion and a tensioning portion. The rotatable portion can have a generally cylindrical body. One or more sutures can be configured to be loaded on the rotatable portion. The tensioning portion can have a spring operably connected to the rotatable portion. The tensioning portion can be configured to provide a predetermined amount of tension on the one or more sutures when the rotatable portion is rotated in one or more directions. Thus, the tensioning portion can allow the rotatable portion to release or take in the suture in order to maintain the proper tension on the suture.

[0006] A suture tensioning device can comprise a rotatable portion, wherein one or more sutures are configured to be releasably loaded on the rotatable portion, and a tensioning portion coupled to the rotatable portion via a connector pin. The tensioning portion can comprise one or more springs configured to provide a predetermined amount of tension on the one or more sutures when the rotatable portion is at any rotational position.

[0007] In some configurations, the one or more springs can be selected from the group consisting of a constant torque spring, a compression spring, or a coiled spring pin.

[0008] In some configurations, the rotatable portion can comprise a locking mechanism for releasably locking the one or more sutures to the rotatable portion.

[0009] In some configurations, the locking mechanism can comprise a toggle configured to apply a frictional force between the one or more sutures and a wall on the rotatable portion to inhibit movement of the one or more sutures.

[0010] In some configurations, the rotatable portion can comprise a suture track configured to spool the one or more sutures. [0011] In some configurations, the one or more springs can comprise a compression spring surrounding a portion of the connector pin. The spring can be configured to be compressed to impart a frictional force along a longitudinal axis of the tensioning device to as to oppose rotation of the tensioning device.

[0012] In some configurations, the tensioning portion can further comprise a housing enclosing the compression spring and at least a portion of the connector pin.

[0013] In some configurations, the housing can be generally cylindrical.

[0014] In some configurations, longitudinal axes of the tensioning portion and the rotatable portion can be generally collinear.

[0015] In some configurations, the tensioning portion can comprise a plurality of radially extending pins slidably disposed within a plurality of helical grooves on an internal wall of the housing.

[0016] In some configurations, the plurality of helical grooves can each comprise a variable pitch so that a substantially constant force is applied on the compression spring when the rotatable portion is rotated.

[0017] In some configurations, the plurality of radially extending pins can engage with adjacent helical grooves after the plurality of radially extending pins have moved along an entire length of the helical grooves engaged by the respective radially extending pins.

[0018] In some configurations, the device can be configured to tension a suture by continuously rotating the rotatable portion without resetting the rotatable portion or the spring.

[0019] In some configurations, the tensioning portion can further comprise an upper disc and a lower disc enclosed within the housing.

[0020] In some configurations, the tensioning portion can comprise a plurality of pillars extending between the upper and lower discs.

[0021] In some configurations, the one or more springs can comprise a leaf spring rolled at two ends of the leaf spring onto a storage spool and an output spool enclosed by a housing of the tensioning portion. [0022] In some configurations, the leaf spring can be rolled onto the storage spool in a first direction and onto the output spool in a second direction that is opposite the first direction.

[0023] In some configurations, the leaf spring can be a constant torque spring.

[0024] In some configurations, the storage spool can have a smaller outer diameter than the output spool.

[0025] In some configurations, the connector pin can extend through a central hole of the output spool.

[0026] In some configurations, a longitudinal axis of the rotating portion is generally collinear with a longitudinal axis of the output spool.

[0027] In some configurations, the device can further comprise one or more locking mechanisms for releasably coupling the rotatable portion to the tensioning portion.

[0028] In some configurations, the rotatable portion can comprise a cylindrical body.

[0029] In some configurations, rotation of the rotatable portion can be configured to apply a rotational or tensile force on the one or more springs.

[0030] In some configurations, the one or more springs can comprise a coiled spring pin.

[0031] In some configurations, the rotatable portion can comprise an extended position and a recessed position relative to a housing of the tensioning portion.

[0032] In some configurations, the rotatable portion can be rotatable in the extended position.

[0033] In some configurations, the rotatable portion can be inhibited from rotating and can be configured to maintain a predetermined amount of tension on the one or more sutures in the recessed position.

[0034] In some configurations, the device can comprise a connector assembly configured to couple with a sheath or a handle of a knot tying device.

[0035] In some configurations, the connector assembly can comprise a clamshell assembly. [0036] In some configurations, the device can further comprise an extended arm between the tensioning portion and the connector assembly.

[0037] In some configurations, the device can be configured to provide and/or maintain a desired amount of tension on the one or more sutures at any point during a procedure.

[0038] In some configurations, the device can be configured to provide the same amount of tension on the one or more sutures at any point during a procedure. In some configurations, the device can be configured to provide different amounts of tension on the one or more sutures at any point during a procedure.

[0039] A system for tensioning suture can comprise any of the suture tensioning device disclosed herein. The suture tensioning device can be configured to maintain a specified amount of tension on the suture. The suture can be coupled to an introducer sheath or knot-forming device.

[0040] In some configurations, the system can comprise the knot-forming device and the suture can be coupled to the knot-forming device. The knot-forming device can comprise a knot body and a plug. The suture can be configured to be secured between an inner wall surface of the knot body and the plug at least partially received within the knot body.

[0041] In some configurations, the system can further comprise a second suture tensioning device such as any suture tensioning device disclosed herein. The second suture tensioning device can be configured to maintain a specified amount of tension on a different suture.

[0042] A suture tensioning device can comprise a rotatable portion and a tensioning portion coupled to the rotatable portion via a connector pin. One or more sutures can be configured to be releasably loaded on the rotatable portion. The tensioning portion can comprise a compression spring surrounding a portion of the connector pin. The tensioning portion can further comprise rotational guide tracks having variable pitches configured to guide rotation of the rotatable portion about a longitudinal axis of the rotational portion. The spring can be configured to be compressed so as to provide a predetermined amount of tension on the one or more sutures when the rotatable portion is at any rotational position.

[0043] In some configurations, the tensioning portion can further comprise a housing enclosing the compression spring and at least a portion of the connector pin.

[0044] In some configurations, the housing can be generally cylindrical.

[0045] In some configurations, longitudinal axes of the tensioning portion and the rotatable portion can be generally collinear.

[0046] In some configurations, the rotational guide tracks can be on an inner wall of the housing.

[0047] In some configurations, the tensioning portion can further comprise an upper disc and a lower disc enclosed within the housing.

[0048] In some configurations, the tensioning portion can comprise a plurality of pillars extending between the upper and lower discs.

[0049] In some configurations, the variable pitches can be configured to impart a constant compressive force on the compression spring when the rotatable portion is rotated.

[0050] In some configurations, the tensioning portion can further comprise a plurality of radially extending pins slidably disposed within the rotational guide tracks.

[0051] In some configurations, the plurality of radially extending pins can engage with adjacent rotational guide tracks after the plurality of radially extending pins have moved along an entire length of the guide tracks engaged by the respective radially extending pins.

[0052] In some configurations, the device can be configured to tension a suture by continuously rotating the rotatable portion without resetting the rotatable portion or the spring.

[0053] In some configurations, the device can further comprise one or more locking mechanisms for releasably coupling the rotatable portion to the tensioning portion.

[0054] In some configurations, the rotatable portion can comprise a cylindrical body.

[0055] In some configurations, the rotatable portion can comprise a locking mechanism for releasably locking the one or more sutures to the rotatable portion. [0056] In some configurations, the locking mechanism can comprise a toggle configured to apply a frictional force between one or more sutures and a wall on the rotatable portion to inhibit movement.

[0057] In some configurations, the rotatable portion can comprise a suture track configured to spool the one or more sutures.

[0058] A suture tensioning device can comprise a rotatable portion and a tensioning portion coupled to the rotatable portion via a connector pin. One or more sutures can be configured to be releasably loaded on the rotatable portion. The tensioning portion can comprise a leaf spring rolled at two ends of the leaf spring in reverse directions onto a storage spool and an output spool enclosed by a housing of the tensioning portion. The spring can be configured to provide a predetermined amount of tension on the one or more sutures when the rotatable portion is at any rotational position.

[0059] In some configurations, the leaf spring can be a constant torque spring.

[0060] In some configurations, the storage spool can have a smaller outer diameter than the output spool.

[0061] In some configurations, the connector pin can extend through a central hole of the output spool.

[0062] In some configurations, a longitudinal axis of the rotating portion can be generally collinear with a longitudinal axis of the output spool.

[0063] In some configurations, the device can further comprise one or more locking mechanisms for releasably coupling the rotatable portion to the tensioning portion.

[0064] In some configurations, the rotatable portion can comprise a cylindrical body.

[0065] In some configurations, the rotatable portion can comprise a locking mechanism for releasably locking the one or more sutures to the rotatable portion.

[0066] In some configurations, the locking mechanism can comprise a toggle configured to apply a frictional force between one or more sutures and a wall on the rotatable portion to inhibit movement.

[0067] In some configurations, the rotatable portion can comprise a suture track configured to spool the one or more sutures. [0068] A suture tensioning device can comprise a rotatable portion comprising a knob and a shaft extending from the knob and a tensioning portion. One or more sutures can be configured to be releasably loaded on the rotatable portion. The shaft of the rotatable portion can be at least partially within a housing of the tensioning portion and the knob of the rotatable portion is located outside the housing. The tensioning portion can comprise a coiled spring pin operably coupled to the shaft of the rotatable pin. The spring can be configured to provide a predetermined amount of tension on the one or more sutures when the rotatable portion is at any rotational position.

[0069] In some configurations, the knob of the rotatable portion can comprise an extended position and a recessed position relative to the housing of the tensioning portion.

[0070] In some configurations, the knob of the rotatable portion can be rotatable in the extended position.

[0071] In some configurations, the knob of the rotatable portion can be inhibited from rotating and can be configured to maintain a predetermined amount of tension on the one or more sutures in the recessed position.

[0072] In some configurations, the device can comprise a connector assembly configured to couple with a sheath or a handle of a knot tying device.

[0073] In some configurations, the connector assembly can comprise a clamshell assembly.

[0074] In some configurations, the device can further comprise an extended arm between the tensioning portion and the connector assembly.

[0075] A suture tensioning device can comprise one or more of the features described in the foregoing description.

[0076] A method of applying a knot to one or more sutures extending from a patient can comprise delivering a knot forming device over the one or more sutures; and utilizing the suture tensioning device disclosed herein to maintain a desired tension on the one or more sutures during advancement of the knot forming device and during placement of the knot by the knot forming device.

[0077] In some configurations, to maintain a desired tension can comprise providing a different amount of tension during the application of the knot. In some configurations, to maintain a desired tension can comprise providing the same amount of tension during the application of the knot.

[0078] A method of applying a knot in a PFO procedure can comprise delivering a knot forming device over one or more sutures, a first suture extending from a septum primum and a second suture extending from a septum secundum; utilizing a first suture tensioning device such as any suture tensioning device disclosed herein to maintain a desired tension on the first suture; and utilizing a second suture tensioning device such as any suture device disclosed herein to maintain a desired tension on the second suture.

[0079] In some configurations, the first and second suture tensioning devices can maintain the same amount of tension on the first and second sutures, respectively. In some configurations, the first and second suture tensioning devices can maintain different amounts of tension on the first and second sutures, respectively.

[0080] In some configurations, the first and/or second suture tensioning devices can maintain the same amount of tension throughout the application of the knot. In some configurations, the first and/or second suture tensioning devices can maintain different amounts of tension throughout the application of the knot.

[0081] A method of applying a knot to one or more sutures can comprise one or more of the features described in the foregoing description.

BRIEF DESCRIPTION OF DRAWINGS

[0082] The above-mentioned and other features disclosed herein are described below with reference to the drawings of specific embodiments. The illustrated embodiments are intended for illustration, but not limitation. The drawings contain the following figures:

[0083] Figure 1A illustrates a front perspective view of an example suture tensioning device.

[0084] Figure IB illustrates a bottom view of the suture tensioning device of Figure 1A.

[0085] Figure 1C illustrates a top view of the suture tensioning device of Figure

1A.

[0086] Figure 2 illustrates the suture tensioning device of Figure 1 A loaded with suture(s) and being used by a user. [0087] Figure 3A illustrates a bottom perspective view of another example suture tensioning device.

[0088] Figure 3B illustrates a top view of the suture tensioning device of Figure

3A.

[0089] Figure 4A illustrates a front perspective view of another example suture tensioning device.

[0090] Figure 4B illustrates a side perspective view of the suture tensioning device of Figure 4A.

[0091] Figures SA-SB illustrate the suture tensioning device of Figure 4B with an outer housing hidden for illustration purposes.

[0092] Figure 6 illustrates another example suture tensioning device being used by a user.

[0093] Figure 7 illustrates an example spring used in the suture tensioning device of Figure 6.

[0094] Figure 8A illustrates a detailed view of a top portion of the suture tensioning device of Figure 6 with a rotatable portion in an extended position.

[0095] Figure 8B illustrates the suture tensioning device of Figure 6 with the rotatable portion in a recessed position.

[0096] Figures 9A-C illustrates connection of the suture tensioning device of Figure 6 with a sheath.

DETAILED DESCRIPTION

[0097] Described herein are examples of suture/stitch/tether tensioning devices. However, those of skill in the art will appreciate that the disclosure extends beyond the specifically disclosed embodiments and/or drawings, and/or uses obvious modifications and equivalents thereof. Thus, it is intended that the scope of the disclosure herein disclosed should not be limited by any particular embodiments and/or drawings described below.

[0098] A suture tensioning device, such as disclosed herein, can be used as part of an overall suturing system or method mat includes a suturing device used to apply one or more sutures to body tissue. For example, a minimally invasive suturing device may be used to apply one or more sutures to an opening in the body, resulting in suture portions or ends extending away from the body opening and away from the patient. Further details regarding exemplifying suturing devices are found in U.S. Pat. Nos. 6,117,144, 6,562,052, 8,246,636, 9,131,938, 9,326,764, 9,642,616, 9,649,106, and 9,706,988, U.S. Pat. Pub. Nos. 2011/0190793, 2016/0151064, and 2016/0302787, and Int'l. Pat. App. No. PCT/US2016/026965, the entireties of each of which are hereby incorporated by reference.

[0099] With the suture portions extending away from the patient, a user, such as a surgeon, typically applies a knot to tie the suture portions together and close the body opening. A knot forming device may be delivered along the suture portions to the body opening to apply the knot, such as described in U.S. Pat. No. 6,733,509, the entirety of which is incorporated by reference, and Col. 32 In.29 to Col. 33 In. 41 of U.S. Pat. No. 9,131,938.

[0100] For example, a suturing device known as the NobleStitch™ EL, available from HeartStitch, Inc., may be used to close a patent foramen ovale ("PFO") of a heart. In such a procedure, a first suture is placed in the septum primum, and a second suture is placed in the septum secundum, resulting in four suture portions (two separate sutures each with two ends) extending away from the PFO. The KwiKnot™ knot forming device may be delivered over the suture portions, and the suture portions are tensioned to close the PFO. The KwiKnot™ device applies and ejects a knot to the suture portions and against the PFO, after which the suture portions are cut and the KwiKnot™ device is removed from the patient. Further details may be found at https://www.youtube.com/watch?v^7egNvrxxrQ. Int'l Pat. App. No. PCT/IB2018/056250, the entireties of which is hereby incorporated by reference, describe other examples of knot forming devices that can be use with the suture tensioning device examples disclosed herein.

[0101] Embodiments of the suture tensioning device described herein can generally include a rotatable (e.g., translatable, spinable, turnable) portion and a tensioning portion. The rotatable portion can be a spool, disc, cylinder, or other component to wrap a suture around. The rotatable portion can have a first and second end surface (such as a top and bottom surface), and a generally cylindrical body extending between the first and second end surfaces, though the particular shape is not limiting and other shapes can be used as well. One or more sutures can be configured to be releasably loaded on the rotatable portion. The tensioning portion can have a spring operably connected to the rotatable portion. The tensioning portion can be configured to provide a predetermined amount of tension (which may or may not be set by the user) on the one or more sutures when the rotatable portion is rotated in one or more directions. Thus, the tensioning portion can allow the rotatable portion to release or take in the suture in order to maintain the proper tension on the suture. Other embodiments may not use a spring, and may instead use a stretchable band or other tensioning type devices. The suture tensioning device can be then held by a user or attached to a separate device, such as a device being used for forming the knot in medical procedures, such as for closing an opening in a heart wall, other procedures disclosed herein, or any other suitable medical procedures.

[0102] Figures 1A-1C illustrate an embodiment of a suture tensioning device 100 that can include a spring, such as for example a constant torque spring, 112. The suture tensioning device 100 can include a rotatable portion 102 and a tensioning portion 104.

[0103] The tensioning portion 104 can include a housing 106 that is bigger than the rotatable portion 102, though in other embodiments it may be smaller or the same size. In some embodiments, such as shown in Figure 1A and IB, the housing 106 can have a small arc, a big arc, and straight sides tangential to the small and big arcs. As shown in Figure IB, the housing 106 can enclose the spring 112 or other tensioning device. The shape of the housing 106 can be configured to accommodate and enclose one or more storage spools 110 and one or more output spools 108 each mounted on a pin 114 extending along a height of the housing 106. However, the shape of the housing 106 is not limiting, and other shapes such as rectangular footprints, circular footprints, cylinders, etc. can be used. The storage spool 110 can have a smaller outer diameter than the output spool 108. Accordingly, the storage spool 110 can be located on the side of the small arc and the output spool 108 can be located on the side of the big arc. The spring 112 can be wound around the storage spool 110 in a first direction (e.g., clockwise or counterclockwise) and around the output spool 108 in a second direction (e.g., counterclockwise or clockwise) that is opposite the first direction. Between the storage spool 110 and the output spool 108, the spring 112 can be tangential (or generally tangential) to the spools 110, 108. The spring 112 can include a constant torque or constant rotational tension spring, though the type of spring is not limiting. [0104] As illustrated in Figure 1C, a bottom surface of the rotatable portion 102 can face an upper surface of the housing 106, or be embedded partially within the housing 106. The rotatable portion 102 can be mounted to the output spool 108 (e.g., via the pin 114 for mounting the output spool 108 inside the housing 106).

[0105] As shown in Figures 1 A and 1 C, the rotatable portion 102 can be generally cylindrical. The rotatable portion 102 can include a suture track 122 generally transverse to its cylindrical wall, such as around an outer circumference of the rotatable portion. The suture track 122 can contain barriers/walls preventing a suture from escaping the track 122. The rotatable portion 102 can include a slot 116 extending across (for example, diametrically across or partially across) a top surface of the rotatable portion 102. The slot 116 can have a first depth. The top surface can include a recess 120 adjacent the slot 116. In some embodiments, such as shown in Figures 1 A-1C, the recess 120 can be generally fan-shaped. The recess 120 can have a small arc extending away from the slot 116 and a greater arc joining a portion of the slot 116. A toggle component 118 can be positioned at least partially in the recess 120, with a free end 124 of the toggle component 118 extending into the slot 116. The toggle component 118 can be pivoted at or near the small arc of the recess 120. The toggle component 118 can have a length such that when a rotating force is applied to the toggle component 118 in one direction of rotation, the toggle component 118 can be stopped by a wall of the recess 120 such as shown in Figure 1C. In another direction of rotation, the free end 124 of the toggle component 118 can eventually abut a vertical surface of the slot 116 opposite the recess 120. A frictional force between the free end 124 of the toggle component 118 and the vertical surface of the slot 116 can inhibit or prevent further rotation of the toggle component 118 in that direction.

[0106] The friction force can lock a suture to the rotatable portion 102. Figure 2 illustrates the suture tensioning device 100 of Figures 1A-1C loaded with a suture 20. After the suture 20 is wound around the suture track 122 of the rotatable portion 102, free end(s) of the suture can be wedged between the free end 124 of the toggle component 118 and the vertical surface of the slot 116 to secure the suture 20 on the rotatable portion 102. Other ways of securing the suture to the rotatable portion can be used, for example, clips, spring- loaded locking features, and/or other friction features. [0107] A first end of the suture 20 can extend from a tissue inside the patient's body where a knot is to be applied and through an introducer sheath extending from the tissue to outside the patient's body. A second end of the suture 20 can be loaded on the rotatable portion 102 as described above and such as shown in Figure 2. In some embodiments, two loose ends of a suture strand can extend out of the patient and be loaded on the rotatable portion 102. In some embodiments, two tensioning devices 100 can be used, one for each loose end of the suture. The two devices can be separate or attached to one another. Rotating the rotatable portion 102, such as by a user's hand, can cause rotation of the output spool 108 and the storage spool 110.

[0108] The spring 112 described above can exert a force tangential to the output spool 108 and the rotatable portion 102. The tangential force can translate to a tension on the suture 20 loaded on the rotatable portion 102. The spring 112 can be configured to exert a predetermined and/or desired amount of tension on the suture 20 and maintain the amount of tension on the suture 20 when the rotatable portion 102 is rotated clockwise and/or counterclockwise to relax and/or tighten the suture 20 around the tissue. As discussed above, the spring 112 is stored on the storage spool 110 and reverse wound onto the output spool 108. When the spring 112 is released, torque is obtained from the output spool 108 as the spring 112 returns to its natural curvature on the storage spool 108.

[0109] Although not shown in Figures 1A-1C and 2, the suture tensioning device described above can have a rotatable portion including a first portion (such as a first half) and a second portion (such as a second half) defining a slot between the first and second portions. The tensioning device can include a button for releasably locking the first and second halves together, with the suture wedged in the slot between the first and second portion to releasably lock the suture onto the rotatable portion.

[0110] Figures 3A-3B below illustrate perspective views of an embodiment of the suture tensioning device 300 that can have a constant torque spring 312. The suture tensioning device 300 of Figures 3A-3B can have any of features of the suture tensioning device 100 of Figures 1A-1C and 2 described above. Features of the suture tensioning device 100 of Figures 1A-1C and 2 and the suture tensioning device 300 of Figures 3A-3B can be incorporated into each other. Similar components in the devices 100 and 300 share the same last two digits.

[0111] As shown in Figures 3A and 3B, the suture tensioning device 300 can have a locking feature coupled in part to the tensioning portion 304 (e.g., to the housing 306). The locking feature can have a locked position and a release position. The locking feature can include one or more switches extending outside the housing of the tensioning portion. In some embodiments, such as shown in Figures 3A and 3B, the locking feature can include a switch or toggle 326 extending outward from one straight side of the housing 306 and a button 328 on the opposing straight side, though the positions are not limiting. In some examples, the switch or toggle 326 and the button 328 can work together (e.g., applying a tension, frictional force, and the like) to lock the rotatable portion 302 onto the tensioning portion 304. In some examples, the switch or toggle 326 can be deployed to lock the resistance portion 302 onto the tensioning portion 304 and the button 328 can be deployed to release the rotatable portion 302 from the tensioning portion 304, or vice versa. In some embodiments, the locking feature can include a single switch or other quick release mechanisms (e.g., a ball detent and the like).

[0112] Figures 3A and 3B illustrate the locking feature in the locked position. In the locked position, the switch 326 can be at a first position and the button 328 can extend outward from the housing 306 at a first distance. The locked position of the locking feature can lock the rotatable portion 302 onto the tensioning portion 302 (for example, onto the output spool 308) so that rotation of the rotatable portion 302 can translate to rotation of the output spool 308 in the tensioning portion 304.

[0113] The locking feature can be in the release position when the one or more switches are pressed into the housing of the tensioning portion. For example, in the release position, the switch 326 can be toggled to a second position and the button 328 can extend from the housing 306 at a second distance. In some embodiments, the second distance is shorter than the first distance. In other embodiments, the second distance is longer than the first distance. In the release position, the locking feature can uncouple movements of the rotatable and tensioning portions 302, 304. The user can release the tension exerted on the suture by the spring 312 in the tensioning portion 304, and/or reload the suture on the rotatable portion 302. Switching between the release and locked positions can allow the user to reconnect the rotatable portion 302 to the tensioning portion 304 if the two portions 302, 304 become loose, reset the tension applied to the suture, and/or to load different suture(s).

[0114] Figures 4A-4B illustrate perspective views of an embodiment of the suture tensioning device 400 that has a compression spring 412 (such as a helical spring and the like). Figures SA-SB below illustrate perspective views of the suture tensioning device 400 with a housing 406 of the tensioning portion 404 hidden for clarity. The suture tensioning device 400 can have a rotatable portion 402 having any of features of the rotatable portion 102, 302 shown in Figures 1A-3B. The suture tensioning device 400 can have a locking feature substantially the same as the locking feature described above. Features of the device 400 and features of the device 100, 300 can be incorporated into one another. Similar components in the devices 100, 300, and 400 share the same last two digits.

[0115] As shown in Figures 4A-4B, the suture tensioning device 400 can have a compression spring 412 enclosed within the housing 406 of the tensioning portion 404. The housing 406 can be generally cylindrical, though the shape is not limiting. An outer diameter of the housing 406 can be substantially the same as an outer diameter of the rotatable portion 402. However, the shape and size of the housing 406 are not limiting. The rotatable portion 402 can be coupled to the tensioning portion 404 by a pin 414. In some embodiments, a suture tensioning device disclosed herein may include a different connection mechanism between the rotatable portion and the resistance portion, such as by an attractive magnetic force and the like. The rotatable portion 402 and the tensioning portion 404 can be generally concentric, and/or a longitudinal axis of the rotatable portion 402 and a longitudinal axis of the tensioning portion 404 can be generally collinear.

[0116] The compression spring 412 can be located generally below the rotatable portion 402. The pin 414 can extend through the compression spring 412. In some embodiments, the compression 412 can be generally centered relative to the lower surface of the rotatable portion 402. The housing 406 of the tensioning portion 404 can enclose a plurality of (for example, two, three, or four) pillars 430 extending between an upper disc 432 and a lower disc 434 of the tensioning portion 404. In some embodiments, the plurality of pillars 430 can be generally uniformly distributed around the compression spring 412. In some embodiments, the pillars 430 can be arranged in other ways. The plurality of pillars 430 can provide structural support to the tensioning portion 404 and/or inhibit tilting of the rotatable portion 402 when the spring 412 is compressed. In some embodiments, such as shown in Figures 4A-4B and SA-SB, the spring 412 can extend between a lower surface of the upper disc 432 and a spring support block 438. In some embodiments, the spring 412 can extend between the lower surface of the upper disc 432 and an upper surface of the lower disc 434. A length, pitch, and stiffness of the spring 412 can be varied depend on the amount of tensioning needed in the suture(s).

[0117] A plurality of pins (not shown) can extend radially outward from the lower disc 434 of the tensioning portion 404. As shown in Figures SA-SB, the plurality of pins can extend from one or more pin holes 436 located on a cylindrical wall of the lower disc 434. The plurality of pins can slidably fit into a plurality of spiral grooves 440 on an inner wall of the housing 406 of the tensioning portion 404 (shown in Figures 4A-B), respectively. Rotation of the rotatable portion 402 can translate to rotation of the lower disc 434 and the plurality of pins of the tensioning portion 404. The spiral grooves 440 can have variable pitches configured to guide the rotation of the plurality of pins in a generally upward direction (toward the rotatable portion 402) so as to exert a substantially constant force on the spring 412 at any point as the rotatable portion 402 is rotated. The force exerted on the rotatable portion 402 and the sutures loaded on the rotatable portion 402 can be about 0 lb. to about 2 lb. (approx.. 0.9 kg), or about 0.S lb. (approx. 0.23 kg) to about 1 lb. (approx. 0.4S kg), or about 0.S lb. (approx. 0.23 kg). As the plurality of pins continue to move spirally upward to ends of the spiral grooves 440, the plurality of pins can drop downward (such as abruptly drop downward) into adjacent spiral grooves 440. The drop-down distance can be about 1 cm to about S cm, or about 3 cm. The drop-down feature can allow the rotatable portion 402 to rotate to wind and/or unwind a substantially infinite length of suture without having to reset the tension in the rotatable portion 402 and/or the spring 412.

[0118] The compression spring 412 is configured to exert a tensile force along a length of the compression spring when compressed. The compression spring 412 can be configured to exert a force in a direction that is generally parallel to a longitudinal axis of the cylindrical body of the rotatable portion 402 when the spring is compressed. The compressed spring 412 can increase the factional force against rotation of the rotatable portion 402. Rotation of the rotatable portion 402 in a first direction can shorten the spring. Rotation of the rotatable portion 402 in a second direction, opposite the first direction, can reduce the compressive force on the spring 412. The frictional force can translate to a tension on the suture loaded on the rotatable portion 402. As discussed above, after the suture is wound around the suture track 422 of the rotatable portion 402, free end(s) of the suture can be wedged between the free end of the toggle component 418 and the vertical surface of the slot 416 to secure the suture on the rotatable portion 402. Other ways of securing the suture to the rotatable portion can be used, for example, clips, spring-loaded locking features, and/or other friction features.

[0119] Figure 6 below illustrates a perspective view of an embodiment of the suture tensioning device 600 having a coiled spring pin 612 (such as shown in Figure 7). The suture tensioning device 600 can have a rotatable portion 602 and a tensioning portion 604. The rotatable portion 602 can be generally cylindrical. The tensioning portion 604 can have a housing 604 that is bigger than the rotatable portion 602. In some embodiments, the housing 604 can have a generally elliptical shape. The size and shape of the housing 604 are not limiting. The rotatable portion 602 can be coupled to a shaft or connector pin that couples the rotatable portion 602 to the tensioning portion 604. The rotatable portion 602 can be generally centered above the tensioning portion 604. The coiled spring pin 612 can be enclosed in the housing 606 of the tensioning portion 604 and operably coupled to the rotatable portion 602.

[0120] As shown in Figure 8A, the rotatable portion 602 can have an extended position. In the extended position, the rotatable portion 602 can extend above an upper surface of the tensioning portion 604 by a first distance. The rotatable portion 602 can be rotated to a predetermined amount of tension due to the coiled spring pin 612, which is operably coupled to the rotatable portion 602. The user can wind one or more sutures extending from a suturing location inside the patient around a cylindrical body of the rotatable portion 602. Free end(s) of suture(s) can be placed into a slot 616 on the rotatable portion 602 and/or otherwise secured onto the rotatable portion 602. [0121] As shown in Figure 8B, the rotatable portion 602 can have a recessed position. In the recessed position, the rotatable portion 602 can extend above an upper surface of the tensioning portion 604 by a second distance that is shorter than the first distance. The user can press down the rotatable portion 602 from the extended position to the recessed position. The suture(s) can be tensioned to the predetermined amount when the rotatable portion 602 is in the recessed position.

[0122] Advantageously, the tensioning portion 602 of the suture tensioning device 600 can include an extended arm 642 extending from a housing 606 of the tensioning portion 604. As shown below in Figure 9A, a free end of the extended arm 642 can be coupled to a first portion (such as a first half) of a clamshell assembly 644. The first portion of the clamshell assembly 644 can partially accommodate a coupling component 32 of a sheath 30, for example, an introducer sheath. As shown below in Figure 9B, a second portion (such as a second half) of the clamshell assembly 644 can be coupled to the first portion, for example, with mechanical fasteners), adhesive, or otherwise. The sheath 30 can be secured to (such as by its coupling component 32 being enclosed within the clamshell assembly 644) and extend away from the clamshell assembly 644 of the suture tensioning device 600.

[0123] In some embodiments, the suture tensioning device examples disclosed herein can have indicator features, such as different colored zones, to notify the user that the suture is under too little, too much, and/or a desired amount of tension.

[0124] In some embodiments, the suture tensioning device examples disclosed herein can provide and/or maintain the same amount of tension throughout certain surgical procedures. In some embodiments, the suture tensioning device examples disclosed herein can provide and/or maintain different amounts of tension on different sutures. For example, the suture(s) that extend out of the patient can be pre-loaded on a knot forming device such as described above. Loose end(s) of the suture(s) can be loaded on the suture tensioning device, which can provide indication of whether too little, too much, and/or a desired amount of tension is being applied to the suture(s). The desired amount of tension can be different or the same during advancement of the knot forming device and during application of the knot.

[0125] Further, multiple different tensioners can be used if multiple suture ends are extending out to the patient, each tensioner accepting one or more suture ends different from the one or more suture ends held by the other tensioner(s). In some embodiments, such as when used for the PFO procedure described in U.S. Pat. No. 9,131,938, a first tensioning device preset to a first desired amount of tension can be connected to one or more sutures or suture portions applied to the septum primum. A second tensioning device preset to a second desired amount of tension can be connected to one or more sutures or suture portions applied to the septum secundum. The first and second amounts of tension can be the same or different. Each tensioning device can also be set to different tensions during different parts of the procedure as described herein.

[0126] Some embodiments of the suture tensioning device described herein can be coupled to (for example, built onto, glued onto, snapped onto, or otherwise) a handle of a knot-forming device, such as the KwiKnot device described above. Some embodiments of the suture tensioning device described herein can be coupled to (for example, built onto, glued onto, snapped onto, or otherwise) a sheath, such as an introducer sheath, extending from a suturing location inside the patient to outside the patient's body. The suture tensioning device examples disclosed herein can be coupled to (for example, built onto, glued onto, snapped onto, or otherwise) any other device and/or anchoring location. The suture tensioning device examples disclosed herein can free the user's hand during the knot forming procedure and/or can allow the knot forming procedure be performed with one hand.

[0127] Some embodiments of the suture tensioning device described herein are configured to be stand-alone and can be held by a user's hand during the knot forming procedure. The suture tensioning device examples disclosed herein can include auto- tensioning features that can tighten the suture to the desired amount of tension when the user's hand moves toward the suturing location and/or causes the sutures to slack, and/or reduces the tension in the sutures to the desired amount when the user's hand tugs the sutures too tight.

[0128] While several components, techniques and aspects have been described with a certain degree of particularity, it is manifest that many changes can be made in the specific designs, constructions and methodology herein above described without departing from the spirit and scope of this disclosure. [0129] Certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.

[0130] Moreover, while methods may be depicted in the drawings or described in the specification in a particular order, such methods need not be performed in the particular order shown or in sequential order, and that all methods need not be performed, to achieve desirable results. Other methods that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional methods can be performed before, after, simultaneously, or between any of the described methods. Further, the methods may be rearranged or reordered in other implementations. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. Additionally, other implementations are within the scope of this disclosure.

[0131] Conditional language, such as "can," "could," "might," or "may," unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include or do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.

[0132] Conjunctive language such as the phrase "at least one of X, Y, and Z," unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply mat certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z. [0133] Language of degree used herein, such as the terms "approximately," "about," "generally," and "substantially" as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately", "about", "generally," and "substantially" may refer to an amount that is within less than or equal to 10% of, within less than or equal to 5% of, within less than or equal to 1% of, within less than or equal to 0.1% of, and within less than or equal to 0.01% of the stated amount. If the stated amount is 0 (e.g., none, having no), the above recited ranges can be specific ranges, and not within a particular % of the value.

[0134] Some embodiments have been described in connection with the accompanying drawings. The figures are drawn to scale, but such scale should not be limiting, since dimensions and proportions other than what are shown are contemplated and are within the scope of the disclosed inventions. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.

[0135] While a number of embodiments and variations thereof have been described in detail, other modifications and methods of using the same will be apparent to those of skill in the art. Accordingly, it should be understood that various applications, modifications, materials, and substitutions can be made of equivalents without departing from the unique and inventive disclosure herein or the scope of the claims.

[0136]

Claims

WHAT IS CLAIMED IS:

1. A suture tensioning device, the device comprising:

a rotatable portion, wherein one or more sutures are configured to be releasably loaded on the rotatable portion, and

a tensioning portion coupled to the rotatable portion via a connector pin, wherein the tensioning portion comprise one or more springs configured to provide a predetermined amount of tension on the one or more sutures when the rotatable portion is at any rotational position.

2. The suture tensioning device of Claim 1, wherein the one or more springs are selected from the group consisting of a constant torque spring, a compression spring, or a coiled spring pin.

3. The suture tensioning device of Claim 1 or 2, wherein the rotatable portion comprises a locking mechanism for releasably locking the one or more sutures to the rotatable portion.

4. The suture tensioning device of Claim 3, wherein the locking mechanism comprises a toggle configured to apply a frictional force between the one or more sutures and a wall on the rotatable portion to inhibit movement of the one or more sutures.

5. The suture tensioning device of any of Claims 1-4, wherein the rotatable portion comprises a suture track configured to spool the one or more sutures.

6. The suture tensioning device of any of Claim 1-5, wherein the one or more springs comprise a compression spring surrounding a portion of the connector pin, wherein the spring is configured to be compressed to impart a frictional force along a longitudinal axis of the tensioning device to as to oppose rotation of the tensioning device.

7. The suture tensioning device of Claim 6, wherein the tensioning portion further comprises a housing enclosing the compression spring and at least a portion of the connector pin.

8. The suture tensioning device of Claim 7, wherein the housing is generally cylindrical.

9. The suture tensioning device of any of Claim 7 or 8, wherein longitudinal axes of the tensioning portion and the rotatable portion are generally collinear.

10. The suture tensioning device of any of Claims 7-9, wherein the tensioning portion comprises a plurality of radially extending pins slidably disposed within a plurality of helical grooves on an internal wall of the housing.

11. The suture tensioning device of Claim 10, wherein the plurality of helical grooves each comprise a variable pitch so that a substantially constant force is applied on the compression spring when the rotatable portion is rotated.

12. The suture tensioning device of Claim 10 or 11, wherein the plurality of radially extending pins engage with adjacent helical grooves after the plurality of radially extending pins have moved along an entire length of the helical grooves engaged by the respective radially extending pins.

13. The suture tensioning device of Claim 12, wherein the device is configured to tension a suture by continuously rotating the rotatable portion without resetting the rotatable portion or the spring.

14. The suture tensioning device of any of Claims 7-13, wherein the tensioning portion further comprises an upper disc and a lower disc enclosed within the housing.

15. The suture tensioning device of Claim 14, wherein the tensioning portion comprises a plurality of pillars extending between the upper and lower discs.

16. The suture tensioning device of any of Claim 1-5, wherein the one or more springs comprise a leaf spring rolled at two ends of the leaf spring onto a storage spool and an output spool enclosed by a housing of the tensioning portion.

17. The suture tensioning device of Claim 16, wherein the leaf spring is rolled onto the storage spool in a first direction and onto the output spool in a second direction that is opposite the first direction.

18. The suture tensioning device of Claim 16 or 17, wherein the leaf spring is a constant torque spring.

19. The suture tensioning device of any of Claims 16-18, wherein the storage spool has a smaller outer diameter than the output spool.

20. The suture tensioning device of any of Claims 16-19, wherein the connector pin extends through a central hole of the output spool.

21. The suture tensioning device of Claim 20, wherein a longitudinal axis of the rotating portion is generally collinear with a longitudinal axis of the output spool.

22. The suture tensioning device of any of Claims 1-21, further comprising one or more locking mechanisms for releasably coupling the rotatable portion to the tensioning portion.

23. The suture tensioning device of any of Claims 1-22, wherein the rotatable portion comprises a cylindrical body.

24. The suture tensioning device of any of Claims 1-23, wherein rotation of the rotatable portion is configured to apply a rotational or tensile force on the one or more springs.

25. The suture tensioning device of any of Claims 1-3, wherein the one or more springs comprise a coiled spring pin.

26. The suture tensioning device of Claim 25, wherein the rotatable portion comprises an extended position and a recessed position relative to a housing of the tensioning portion.

27. The suture tensioning device of Claim 26, wherein the rotatable portion is rotatable in the extended position.

28. The suture tensioning device of Claim 26 or 27, wherein the rotatable portion is inhibited from rotating and is configured to maintain a predetermined amount of tension on the one or more sutures in the recessed position.

29. The suture tensioning device of any of Claims 25-28, comprising a connector assembly configured to couple with a sheath or a handle of a knot tying device.

30. The suture tensioning device of Claim 29, wherein the connector assembly comprises a clamshell assembly.

31. The suture tensioning device of Claim 29 or 30, further comprising an extended arm between the tensioning portion and the connector assembly.

32. The suture tensioning device of any of Claims 1-31, wherein the device is configured to provide and/or maintain a desired amount of tension on the one or more sutures at any point during a procedure.

33. The suture tensioning device of Claim 32, wherein the device is configured to provide the same amount of tension on the one or more sutures at any point during a procedure.

34. The suture tensioning device of Claim 32, wherein the device is configured to provide different amounts of tension on the one or more sutures at any point during a procedure.

35. A system for tensioning a suture, the system comprising:

a suture tensioning device according to any of Claims 1-34,

wherein the suture tensioning device is configured to maintain a specified amount of tension on the suture, and

wherein the suture is coupled to an introducer sheath or knot-forming device.

36. The system of Claim 35, wherein the system comprises the knot-forming device and the suture is coupled to the knot-forming device, the knot-forming device comprising a knot body and a plug, the suture is configured to be secured between an inner wall surface of the knot body and the plug at least partially received within the knot body.

37. The system of Claim 35 or 36, further comprising a second suture tensioning device according to any of Claims 1-34, wherein the second suture tensioning device is configured to maintain a specified amount of tension on a different suture.

38. A suture tensioning device, the device comprising:

a rotatable portion, wherein one or more sutures are configured to be releasably loaded on the rotatable portion, and

a tensioning portion coupled to the rotatable portion via a connector pin, wherein the tensioning portion comprises a compression spring surrounding a portion of the connector pin, the tensioning portion further comprising rotational guide tracks having variable pitches configured to guide rotation of the rotatable portion about a longitudinal axis of the rotational portion,

wherein the spring is configured to be compressed so as to provide a predetermined amount of tension on the one or more sutures when the rotatable portion is at any rotational position.

39. The suture tensioning device of Claim 38, wherein the tensioning portion further comprises a housing enclosing the compression spring and at least a portion of the connector pin.

40. The suture tensioning device of Claim 39, wherein the housing is generally cylindrical.

41. The suture tensioning device of Claim 40, wherein longitudinal axes of the tensioning portion and the rotatable portion are generally collinear.

42. The suture tensioning device of any of Claims 39-41, wherein the rotational guide tracks are on an inner wall of the housing.

43. The suture tensioning device of any of Claims 39-42, wherein the tensioning portion further comprises an upper disc and a lower disc enclosed within the housing.

44. The suture tensioning device of Claim 44, wherein the tensioning portion comprises a plurality of pillars extending between the upper and lower discs.

45. The suture tensioning device of any of Claims 38-44, wherein the variable pitches are configured to impart a constant compressive force on the compression spring when the rotatable portion is rotated.

46. The suture tensioning device of any of Claims 38-45, wherein the tensioning portion further comprises a plurality of radially extending pins slidably disposed within the rotational guide tracks.

47. The suture tensioning device of Claim 46, wherein the plurality of radially extending pins engage with adjacent rotational guide tracks after the plurality of radially extending pins have moved along an entire length of the guide tracks engaged by the respective radially extending pins.

48. The suture tensioning device of Claim 47, wherein the device is configured to tension a suture by continuously rotating the rotatable portion without resetting the rotatable portion or the spring.

49. The suture tensioning device of any of Claims 38-48, further comprising one or more locking mechanisms for releasably coupling the rotatable portion to the tensioning portion.

50. The suture tensioning device of any of Claims 38-49, wherein the rotatable portion comprises a cylindrical body.

51. The suture tensioning device of any of Claims 38-50, wherein the rotatable portion comprises a locking mechanism for releasably locking the one or more sutures to the rotatable portion.

52. The suture tensioning device of any of Claim 51, wherein the locking mechanism comprises a toggle configured to apply a frictional force between one or more sutures and a wall on the rotatable portion to inhibit movement.

53. The suture tensioning device of any of Claims 38-52, wherein the rotatable portion comprises a suture track configured to spool the one or more sutures.

54. A suture tensioning device, the device comprising:

a rotatable portion, wherein one or more sutures are configured to be releasably loaded on the rotatable portion, and

a tensioning portion coupled to the rotatable portion via a connector pin, wherein the tensioning portion comprises a leaf spring rolled at two ends of the leaf spring in reverse directions onto a storage spool and an output spool enclosed by a housing of the tensioning portion,

wherein the spring is configured to provide a predetermined amount of tension on the one or more sutures when the rotatable portion is at any rotational position.

55. The suture tensioning device of Claim 54, wherein the leaf spring is a constant torque spring.

56. The suture tensioning device of Claim 54 or 55, wherein the storage spool has a smaller outer diameter than the output spool.

57. The suture tensioning device of any of Claims 54-56, wherein the connector pin extends through a central hole of the output spool.

58. The suture tensioning device of Claim 57, wherein a longitudinal axis of the rotating portion is generally collinear with a longitudinal axis of the output spool.

59. The suture tensioning device of any of Claims 54-58, further comprising one or more locking mechanisms for releasably coupling the rotatable portion to the tensioning portion.

60. The suture tensioning device of any of Claims 54-59, wherein the rotatable portion comprises a cylindrical body.

61. The suture tensioning device of any of Claims 54-60, wherein the rotatable portion comprises a locking mechanism for releasably locking the one or more sutures to the rotatable portion.

62. The suture tensioning device of any of Claim 61, wherein the locking mechanism comprises a toggle configured to apply a frictional force between one or more sutures and a wall on the rotatable portion to inhibit movement.

63. The suture tensioning device of any of Claims 54-62, wherein the rotatable portion comprises a suture track configured to spool the one or more sutures.

64. A suture tensioning device, the device comprising:

a rotatable portion comprising a knob and a shaft extending from the knob, wherein one or more sutures are configured to be releasably loaded on the rotatable portion, and

a tensioning portion, wherein the shaft of the rotatable portion is at least partially within a housing of the tensioning portion and the knob of the rotatable portion is located outside the housing, the tensioning portion comprising a coiled spring pin operably coupled to the shaft of the rotatable pin, and

wherein the spring is configured to provide a predetermined amount of tension on the one or more sutures when the rotatable portion is at any rotational position.

65. The suture tensioning device of Claim 64, wherein the knob of the rotatable portion comprises an extended position and a recessed position relative to the housing of the tensioning portion.

66. The suture tensioning device of Claim 65, wherein the knob of the rotatable portion is rotatable in the extended position.

67. The suture tensioning device of Claim 65 or 66, wherein the knob of the rotatable portion is inhibited from rotating and is configured to maintain a predetermined amount of tension on the one or more sutures in the recessed position.

68. The suture tensioning device of any of Claims 64-67, comprising a connector assembly configured to couple with a sheath or a handle of a knot tying device.

69. The suture tensioning device of Claim 68, wherein the connector assembly comprises a clamshell assembly.

70. The suture tensioning device of Claim 68 or 69, further comprising an extended arm between the tensioning portion and the connector assembly.

71. A suture tensioning device comprising one or more of the features described in the foregoing description.

72. A method of applying a knot to one or more sutures extending from a patient, the method comprising:

delivering a knot forming device over the one or more sutures; and utilizing a suture tensioning device according to any of Claims 1-71 to maintain a desired tension on the one or more sutures during advancement of the knot forming device and during placement of the knot by the knot forming device.

73. The method of Claim 72, wherein to maintain a desired tension comprises providing a different amount of tension during the application of the knot.

74. The method of Claim 72, wherein to maintain a desired tension comprises providing the same amount of tension during the application of the knot.

75. A method of applying a knot in a PFO procedure, the method comprising: delivering a knot forming device over one or more sutures, a first suture extending from a septum primum and a second suture extending from a septum secundum;

utilizing a first suture tensioning device according to any of Claims 1-71 to maintain a desired tension on the first suture; and

utilizing a second suture tensioning device according to any of Claims 1-71 to maintain a desired tension on the second suture.

76. The method of Claim 75, wherein the first and second suture tensioning devices maintain the same amount of tension on the first and second sutures, respectively.

77. The method of Claim 75, wherein the first and second suture tensioning devices maintain different amounts of tension on the first and second sutures, respectively.

78. The method of any of Claims 75-77, wherein the first and/or second suture tensioning devices maintain the same amount of tension throughout the application of the knot.

79. The method of any of Claims 75-77, wherein the first and/or second suture tensioning devices maintain different amounts of tension throughout the application of the knot.

80. A method comprising one or more of the features described in the foregoing description.