WO2019055433A1 - Dispositif de tension de suture - Google Patents

Dispositif de tension de suture Download PDF

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Publication number
WO2019055433A1
WO2019055433A1 PCT/US2018/050519 US2018050519W WO2019055433A1 WO 2019055433 A1 WO2019055433 A1 WO 2019055433A1 US 2018050519 W US2018050519 W US 2018050519W WO 2019055433 A1 WO2019055433 A1 WO 2019055433A1
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WO
WIPO (PCT)
Prior art keywords
suture
tensioning device
rotatable portion
suture tensioning
sutures
Prior art date
Application number
PCT/US2018/050519
Other languages
English (en)
Inventor
Anthony A. Nobles
Ian BABCOCK
Original Assignee
Nobles Medical Technologies Ii, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nobles Medical Technologies Ii, Inc. filed Critical Nobles Medical Technologies Ii, Inc.
Publication of WO2019055433A1 publication Critical patent/WO2019055433A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0483—Hand-held instruments for holding sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures

Definitions

  • 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.
  • the suture portions 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.
  • pulling the suture portions too tight can be undesirable, as it can result in rupturing of the suture portions or damaging the surrounding tissue.
  • an accelerated heart beat can push the sutures against the myocardium until the sutures rupture.
  • having too little tension e.g., loose sutures
  • a user 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the rotatable portion can comprise a locking mechanism for releasably locking the one or more sutures to the rotatable portion.
  • 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.
  • the rotatable portion can comprise a suture track configured to spool the one or more sutures.
  • 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.
  • the tensioning portion can further comprise a housing enclosing the compression spring and at least a portion of the connector pin.
  • the housing can be generally cylindrical.
  • longitudinal axes of the tensioning portion and the rotatable portion can be generally collinear.
  • 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.
  • 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.
  • 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.
  • the device can be configured to tension a suture by continuously rotating the rotatable portion without resetting the rotatable portion or the spring.
  • the tensioning portion can further comprise an upper disc and a lower disc enclosed within the housing.
  • the tensioning portion can comprise a plurality of pillars extending between the upper and lower discs.
  • 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.
  • 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.
  • the leaf spring can be a constant torque spring.
  • the storage spool can have a smaller outer diameter than the output spool.
  • the connector pin can extend through a central hole of the output spool.
  • a longitudinal axis of the rotating portion is generally collinear with a longitudinal axis of the output spool.
  • the device can further comprise one or more locking mechanisms for releasably coupling the rotatable portion to the tensioning portion.
  • the rotatable portion can comprise a cylindrical body.
  • rotation of the rotatable portion can be configured to apply a rotational or tensile force on the one or more springs.
  • the one or more springs can comprise a coiled spring pin.
  • the rotatable portion can comprise an extended position and a recessed position relative to a housing of the tensioning portion.
  • the rotatable portion can be rotatable in the extended position.
  • 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.
  • the device can comprise a connector assembly configured to couple with a sheath or a handle of a knot tying device.
  • the connector assembly can comprise a clamshell assembly.
  • the device can further comprise an extended arm between the tensioning portion and the connector assembly.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the tensioning portion can further comprise a housing enclosing the compression spring and at least a portion of the connector pin.
  • the housing can be generally cylindrical.
  • longitudinal axes of the tensioning portion and the rotatable portion can be generally collinear.
  • the rotational guide tracks can be on an inner wall of the housing.
  • the tensioning portion can further comprise an upper disc and a lower disc enclosed within the housing.
  • the tensioning portion can comprise a plurality of pillars extending between the upper and lower discs.
  • variable pitches can be configured to impart a constant compressive force on the compression spring when the rotatable portion is rotated.
  • the tensioning portion can further comprise a plurality of radially extending pins slidably disposed within the rotational guide tracks.
  • 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.
  • the device can be configured to tension a suture by continuously rotating the rotatable portion without resetting the rotatable portion or the spring.
  • the device can further comprise one or more locking mechanisms for releasably coupling the rotatable portion to the tensioning portion.
  • the rotatable portion can comprise a cylindrical body.
  • the rotatable portion can comprise a locking mechanism for releasably locking the one or more sutures to the rotatable portion.
  • 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.
  • the rotatable portion can comprise a suture track configured to spool the one or more sutures.
  • 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.
  • the leaf spring can be a constant torque spring.
  • the storage spool can have a smaller outer diameter than the output spool.
  • the connector pin can extend through a central hole of the output spool.
  • a longitudinal axis of the rotating portion can be generally collinear with a longitudinal axis of the output spool.
  • the device can further comprise one or more locking mechanisms for releasably coupling the rotatable portion to the tensioning portion.
  • the rotatable portion can comprise a cylindrical body.
  • the rotatable portion can comprise a locking mechanism for releasably locking the one or more sutures to the rotatable portion.
  • 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.
  • the rotatable portion can comprise a suture track configured to spool the one or more sutures.
  • 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.
  • the knob of the rotatable portion can comprise an extended position and a recessed position relative to the housing of the tensioning portion.
  • the knob of the rotatable portion can be rotatable in the extended position.
  • 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.
  • the device can comprise a connector assembly configured to couple with a sheath or a handle of a knot tying device.
  • the connector assembly can comprise a clamshell assembly.
  • the device can further comprise an extended arm between the tensioning portion and the connector assembly.
  • a suture tensioning device can comprise one or more of the features described in the foregoing description.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a method of applying a knot to one or more sutures can comprise one or more of the features described in the foregoing description.
  • Figure 1A illustrates a front perspective view of an example suture tensioning device.
  • Figure IB illustrates a bottom view of the suture tensioning device of Figure 1A.
  • Figure 1C illustrates a top view of the suture tensioning device of Figure
  • Figure 2 illustrates the suture tensioning device of Figure 1 A loaded with suture(s) and being used by a user.
  • Figure 3A illustrates a bottom perspective view of another example suture tensioning device.
  • Figure 3B illustrates a top view of the suture tensioning device of Figure
  • Figure 4A illustrates a front perspective view of another example suture tensioning device.
  • Figure 4B illustrates a side perspective view of the suture tensioning device of Figure 4A.
  • Figures SA-SB illustrate the suture tensioning device of Figure 4B with an outer housing hidden for illustration purposes.
  • Figure 6 illustrates another example suture tensioning device being used by a user.
  • Figure 7 illustrates an example spring used in the suture tensioning device of Figure 6.
  • 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.
  • Figure 8B illustrates the suture tensioning device of Figure 6 with the rotatable portion in a recessed position.
  • Figures 9A-C illustrates connection of the suture tensioning device of Figure 6 with a sheath.
  • 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.
  • 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.
  • a user 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.
  • a suturing device known as the NobleStitchTM EL, available from HeartStitch, Inc.
  • a suturing device known as the NobleStitchTM EL, available from HeartStitch, Inc.
  • PFO patent foramen ovale
  • 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 KwiKnotTM knot forming device may be delivered over the suture portions, and the suture portions are tensioned to close the PFO.
  • the KwiKnotTM device applies and ejects a knot to the suture portions and against the PFO, after which the suture portions are cut and the KwiKnotTM 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.
  • 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.
  • 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.
  • FIGS 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.
  • 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.
  • the housing 106 can have a small arc, a big arc, and straight sides tangential to the small and big arcs.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • FIG. 2 illustrates the suture tensioning device 100 of Figures 1A-1C loaded with a suture 20.
  • 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.
  • 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.
  • two loose ends of a suture strand can extend out of the patient and be loaded on the rotatable portion 102.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIGS 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the locking feature can include a single switch or other quick release mechanisms (e.g., a ball detent and the like).
  • Figures 3A and 3B illustrate the locking feature 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.
  • the locking feature can be in the release position when the one or more switches are pressed into the housing of the tensioning portion.
  • the switch 326 can be toggled to a second position and the button 328 can extend from the housing 306 at a second distance.
  • the second distance is shorter than the first distance. In other embodiments, the second distance is longer than the first distance.
  • 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).
  • FIGS 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.
  • 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.
  • 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.
  • 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.
  • the compression spring 412 can be located generally below the rotatable portion 402.
  • the pin 414 can extend through the compression spring 412.
  • 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.
  • the plurality of pillars 430 can be generally uniformly distributed around the compression spring 412.
  • 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.
  • 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).
  • a plurality of pins 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).
  • 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.
  • 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.
  • 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.
  • FIG. 6 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the suture tensioning device examples disclosed herein can provide and/or maintain the same amount of tension throughout certain surgical procedures.
  • the suture tensioning device examples disclosed herein can provide and/or maintain different amounts of tension on different sutures.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne des dispositifs de tension de suture pouvant améliorer la facilité et/ou le succès d'un utilisateur du typage d'un noeud de suture. Le dispositif de tension de suture peut être tenu par un utilisateur ou fixé à un dispositif séparé, tel qu'un dispositif utilisé pour la formation de noeud. Des modes de réalisation des dispositifs de tension de suture décrits ici peuvent généralement comprendre une partie rotative et une partie tension. Une ou plusieurs sutures peuvent être configurées pour être chargées sur la partie rotative. La partie tension peut avoir un ressort relié de manière fonctionnelle à la partie rotative. La partie tension peut être configurée pour fournir une quantité prédéterminée de tension sur la ou les sutures lorsque la partie rotative est tournée dans une ou plusieurs directions.
PCT/US2018/050519 2017-09-12 2018-09-11 Dispositif de tension de suture WO2019055433A1 (fr)

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US201762557401P 2017-09-12 2017-09-12
US62/557,401 2017-09-12

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10610216B2 (en) 2011-04-15 2020-04-07 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic valve
US10687801B2 (en) 2016-04-11 2020-06-23 Nobles Medical Technologies Ii, Inc. Suture spools for tissue suturing device
US10758223B2 (en) 2005-06-20 2020-09-01 Scarab Technology Services, Llc Method and apparatus for applying a knot to a suture
US10828022B2 (en) 2013-07-02 2020-11-10 Med-Venture Investments, Llc Suturing devices and methods for suturing an anatomic structure
US11051802B2 (en) 2012-05-11 2021-07-06 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic structure
US11166712B2 (en) 2008-05-09 2021-11-09 Scarab Technology Services, Llc Suturing devices and methods for suturing an anatomic valve
US11202624B2 (en) 2017-08-18 2021-12-21 Nobles Medical Technologies Ii, Inc. Apparatus for applying a knot to a suture
US11395658B2 (en) 2014-07-11 2022-07-26 Cardio Medical Solutions, Inc. Device and method for assisting end-to-side anastomosis
EP3972498A4 (fr) * 2019-06-10 2023-02-01 LSI Solutions, Inc. Dispositif de tension de suture et procédés associés
US11779324B2 (en) 2013-12-06 2023-10-10 Med-Venture Investments, Llc Suturing methods and apparatuses
US11839370B2 (en) 2017-06-19 2023-12-12 Heartstitch, Inc. Suturing devices and methods for suturing an opening in the apex of the heart
US11957331B2 (en) 2017-06-19 2024-04-16 Heartstitch, Inc. Suturing systems and methods for suturing body tissue

Citations (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6117144A (en) 1995-08-24 2000-09-12 Sutura, Inc. Suturing device and method for sealing an opening in a blood vessel or other biological structure
US6562052B2 (en) 1995-08-24 2003-05-13 Sutura, Inc. Suturing device and method
US6733509B2 (en) 2000-08-25 2004-05-11 Sutura, Inc. Suture cutter
EP1852071A2 (fr) * 2006-05-02 2007-11-07 Ethicon Endo-Surgery, Inc. Dispositif et méthode de mise sous tension d'une suture
EP1987779A1 (fr) * 2007-05-02 2008-11-05 Arthrex, Inc. Dispositif de tension de sutures
US20100094314A1 (en) * 2008-10-10 2010-04-15 Hernlund Jonathan D Tether tensioning devices and related methods
US20110190793A1 (en) 2010-01-29 2011-08-04 Med-Venture Investments, Llc Methods and apparatuses for suturing of cardiac openings
WO2012012336A2 (fr) * 2010-07-19 2012-01-26 Wound Care Technologies, Inc. Système de fermeture de plaie
US8246636B2 (en) 2007-03-29 2012-08-21 Nobles Medical Technologies, Inc. Suturing devices and methods for closing a patent foramen ovale
EP2572649A2 (fr) * 2011-09-23 2013-03-27 Karl Storz GmbH & Co. KG Dispositif d'étirement de la peau
WO2013142487A1 (fr) * 2012-03-22 2013-09-26 Cook Medical Technologies Llc Cartouches de suture et procédé d'utilisation de celle-ci
US9326764B2 (en) 2008-05-09 2016-05-03 Nobles Medical Technologies Inc. Suturing devices and methods for suturing an anatomic valve
US20160151064A1 (en) 2013-07-02 2016-06-02 Med-Venture Investments, Llc Suturing devices and methods for suturing an anatomic structure
US20160302787A1 (en) 2013-12-06 2016-10-20 Med-Venture Investments, Llc Suturing methods and apparatuses
US9642616B2 (en) 2005-06-20 2017-05-09 Nobles Medical Technologies, Inc. Method and apparatus for applying a knot to a suture
US9649106B2 (en) 2011-04-15 2017-05-16 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic valve
US9706988B2 (en) 2012-05-11 2017-07-18 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic structure

Patent Citations (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6562052B2 (en) 1995-08-24 2003-05-13 Sutura, Inc. Suturing device and method
US6117144A (en) 1995-08-24 2000-09-12 Sutura, Inc. Suturing device and method for sealing an opening in a blood vessel or other biological structure
US6733509B2 (en) 2000-08-25 2004-05-11 Sutura, Inc. Suture cutter
US9642616B2 (en) 2005-06-20 2017-05-09 Nobles Medical Technologies, Inc. Method and apparatus for applying a knot to a suture
EP1852071A2 (fr) * 2006-05-02 2007-11-07 Ethicon Endo-Surgery, Inc. Dispositif et méthode de mise sous tension d'une suture
US8246636B2 (en) 2007-03-29 2012-08-21 Nobles Medical Technologies, Inc. Suturing devices and methods for closing a patent foramen ovale
US9131938B2 (en) 2007-03-29 2015-09-15 Nobles Medical Technologies, Inc. Suturing devices and methods for closing a patent foramen ovale
EP1987779A1 (fr) * 2007-05-02 2008-11-05 Arthrex, Inc. Dispositif de tension de sutures
US9326764B2 (en) 2008-05-09 2016-05-03 Nobles Medical Technologies Inc. Suturing devices and methods for suturing an anatomic valve
US20100094314A1 (en) * 2008-10-10 2010-04-15 Hernlund Jonathan D Tether tensioning devices and related methods
US20110190793A1 (en) 2010-01-29 2011-08-04 Med-Venture Investments, Llc Methods and apparatuses for suturing of cardiac openings
WO2012012336A2 (fr) * 2010-07-19 2012-01-26 Wound Care Technologies, Inc. Système de fermeture de plaie
US9649106B2 (en) 2011-04-15 2017-05-16 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic valve
EP2572649A2 (fr) * 2011-09-23 2013-03-27 Karl Storz GmbH & Co. KG Dispositif d'étirement de la peau
WO2013142487A1 (fr) * 2012-03-22 2013-09-26 Cook Medical Technologies Llc Cartouches de suture et procédé d'utilisation de celle-ci
US9706988B2 (en) 2012-05-11 2017-07-18 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic structure
US20160151064A1 (en) 2013-07-02 2016-06-02 Med-Venture Investments, Llc Suturing devices and methods for suturing an anatomic structure
US20160302787A1 (en) 2013-12-06 2016-10-20 Med-Venture Investments, Llc Suturing methods and apparatuses

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10758223B2 (en) 2005-06-20 2020-09-01 Scarab Technology Services, Llc Method and apparatus for applying a knot to a suture
US11744576B2 (en) 2005-06-20 2023-09-05 Scarab Technology Services, Llc Method and apparatus for applying a knot to a suture
US11166712B2 (en) 2008-05-09 2021-11-09 Scarab Technology Services, Llc Suturing devices and methods for suturing an anatomic valve
US10610216B2 (en) 2011-04-15 2020-04-07 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic valve
US10624629B2 (en) 2011-04-15 2020-04-21 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic valve
US11051802B2 (en) 2012-05-11 2021-07-06 Heartstitch, Inc. Suturing devices and methods for suturing an anatomic structure
US10828022B2 (en) 2013-07-02 2020-11-10 Med-Venture Investments, Llc Suturing devices and methods for suturing an anatomic structure
US11779324B2 (en) 2013-12-06 2023-10-10 Med-Venture Investments, Llc Suturing methods and apparatuses
US11395658B2 (en) 2014-07-11 2022-07-26 Cardio Medical Solutions, Inc. Device and method for assisting end-to-side anastomosis
US10687801B2 (en) 2016-04-11 2020-06-23 Nobles Medical Technologies Ii, Inc. Suture spools for tissue suturing device
US11839370B2 (en) 2017-06-19 2023-12-12 Heartstitch, Inc. Suturing devices and methods for suturing an opening in the apex of the heart
US11957331B2 (en) 2017-06-19 2024-04-16 Heartstitch, Inc. Suturing systems and methods for suturing body tissue
US11202624B2 (en) 2017-08-18 2021-12-21 Nobles Medical Technologies Ii, Inc. Apparatus for applying a knot to a suture
EP3972498A4 (fr) * 2019-06-10 2023-02-01 LSI Solutions, Inc. Dispositif de tension de suture et procédés associés

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