Abstract:
Provided herein is a mechanical device including a rotating spool assembly and a disposable valve assembly. The rotating spool assembly includes a hub, an arm, and a spool inserted through an opening in the arm. The rotating spool assembly can be sterilized after each use. The disposable valve assembly includes a mating stem member, a sealing member, and a flushing port member. The disposable valve assembly can be disposed of after every use. A loading member is also provided including a wire that can be formed from metal drawn out into a thin flexible thread. The loading member can be pre-formed in a helix to form coils in the wire. A release cord is provided including a braided cord with two single filaments and a plurality of beads formed along a length of the single filaments at a distal end of the braided cord.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims priority to U.S. Provisional Application No. 62/085,272 entitled “Tissue Ligation Apparatus With a Rotating Spool Assembly and a Valve Assembly” filed Nov. 27, 2014, which is hereby incorporated by reference in its entirety. 
     
    
     FIELD 
       [0002]    The present disclosure relates generally to tissue ligation. 
       BACKGROUND 
       [0003]    Swollen and enlarged veins in the esophagus are commonly called esophageal varices. Esophageal varices have the potential to rupture and cause excessive bleeding in the esophagus, which can cause death in certain circumstances. Ligation of the varices can be performed to treat bleeding varices. Ligation can also be performed as a preventative measure to strangulate and remove the varices before they reach a stage where bleeding is a distinct risk. For ligation to be successfully performed through common practice, the varices must be pulled into a hollow chamber through suction, whereby elastic ligation bands are released over the tissue to strangulate it. Strangulation leads to death of the tissue and the subsequent natural detachment of the varices. 
         [0004]    Endoscopic hemorrhoid band ligation (HBL), similar in technique to the variceal banding described above is an important advancement in the treatment of symptomatic internal hemorrhoids (IH). Multiple rubber bands can be applied in one session, and further bands can be applied in subsequent sessions if a single session fails to completely eradicate the internal hemorrhoids. The treatment success rate is high, while the long-term recurrence rate is low. Symptomatic hemorrhoids in adults is considered one of the most prevalent anorectal disorders. Hemorrhoids of different grades can be found in more than 80%-90% of patients undergoing sigmoidoscopy or colonoscopy. Hemorrhoids are either internal or external depending on the localization above or below the dentate line. 
         [0005]    A new successful technique for the treatment of high grade dysplasia is endoscopic mucosal resection. This involves the piece-meal endoscopic resection of early neoplastic lesions larger than 15-20 mm. Before using band ligation, this was a laborious procedure. Multiband mucosectomy is a new safe and very effective technique using a modified variceal band ligator. Sub-mucosal lifting and pre-looping of the snare in the cap is not necessary and multiple resections can be performed with a single snare. The ligator suctions the targeted tissue into pseudo polyps and then the snare removes them in succession. 
         [0006]    For all three situations mentioned above, the ligation is performed in conjunction with an endoscope or other device that can be used to allow deep access to the human digestive tract. Endoscopes generally consist of a rigid or flexible tube with a working channel of varying internal diameters to allow a variety of medical instruments to be deployed and used in the human digestive tract. Endoscopes also feature a camera on the distal tip of the flexible tube to allow direct visualization of the digestive tract as well as light, suction and fluid delivery systems. 
         [0007]    Devices that facilitate this functionality are commonly called multi-band ligation devices. These devices consist of a hollow cylindrical barrel component which fits on the distal end of the endoscope, and that is configured to apply multiple bands over tissue suctioned into the device. There are many examples of multi-band ligation devices currently in use today. As well as this, a variety of instruments for effecting the ligation of body tissue by the application of an elastic band are known in the art in the form of single ligation band devices. 
       SUMMARY 
       [0008]    Various methods and devices are provided for performing band ligation. In one aspect, an endoscopic surgical device has a rotating spool assembly and a valve assembly. The rotating spool assembly has a hub, an arm contiguous with the hub, and a rotating spool inserted through the arm. The hub has an opening formed therein. The valve assembly has a mating stem member, a sealing member, and a flushing port member. The mating stem member has a lumen extending through a longitudinal center thereof and has the sealing member extending thereacross. The lumen is aligned on a proximal end of the mating stem member with the opening in the rotating spool assembly. The valve assembly is coupled to a distal end of the rotating spool assembly. 
         [0009]    The endoscopic surgical device can vary in a variety of ways. For example, the rotating spool assembly can include a substantially hook-shaped member that rotates as one with the spool, the substantially hook-shaped member being configured to receive a cable. As another example, the spool can comprise a tapered toothed groove sized to grip a release cord. In another example, the spool can include first and second posts protruding from a surface thereof and positioned next to one another. The first and second posts can be configured to receive a cable therearound. In another embodiment, the spool can comprise at least one post protruding from a surface thereof and a groove in the surface positioned proximally from the post. As another example, the mating stem member can include an upper body with one or more tabs formed on the upper body. The mating stem member can also include a tapered section at a distal end thereof, and the tapered section can be shaped to be inserted into an auxiliary port of an endoscope to form a surface-to-surface mating engagement with a corresponding internal geometry of the auxiliary port. As another example, the rotating spool assembly can couple to the valve assembly using a quarter turn bayonet fitting. 
         [0010]    In another aspect, an endoscopic surgical device is provided that has a spool assembly and a loading wire. The spool assembly has a rotating member and a stem having a lumen extending therethrough. The loading wire extends through the lumen in the stem of the spool assembly. The loading wire also has a proximal end extending proximally from the lumen in the stem toward and has a distal end extending distally from the lumen in the stem. The distal end of the loading wire has a hook formed thereon and is configured to couple to a thread such that the proximal end of the loading wire can be pulled proximally to pull the thread through the spool assembly. 
         [0011]    The endoscopic surgical device can be varied in a variety of ways. For example, the loading wire can be formed from metal drawn out into a thin flexible thread. As another example, the loading wire can form one or more coils. The coils can constrain the wire in a coiled configuration in a first position when the wire is separated from the spool assembly, and the wire can conform to a longitudinal shape of the lumen in a second position when the wire is disposed through the lumen. In another embodiment, the proximal end of the loading wire includes a hook formed thereon. In another example, the hooks can be formed from the wire being turned back upon itself to form a hook shape, and a central axis of a distal end of each hook can be co-linear with a central axis of the wire. The loading member can also be formed from a braiding of two or more single wires. As another example, the loading member can be formed from a polymer. A central segment of the wire can also form one or more coils, and proximal and distal portions of the wire can be formed of straight sections. 
         [0012]    In another aspect, a release cord is provided with a braided cord and a plurality of beads. The braided cord has first and second single filaments. The single filaments are braided together at a proximal end of the braided cord and separated at a distal end of the braided cord. The plurality of beads are formed along a length of each of the first and second single filaments at the distal end of the braided cord. The plurality of beads are positioned such that no two beads are at a same distance from the proximal end of the braided cord. 
         [0013]    The release cord can be varied in a variety of ways. For example, the beads can be substantially spherical. The beads can also be made of a polymer. In another example, a proximal section of the release cord can be formed into a closed loop configuration, and the closed looped configuration can be sized to fit through a working channel of an endoscope. In another example, the closed looped configuration at the proximal end can be created by attaching a separate closed loop shaped component through mechanical means. 
         [0014]    In another aspect, a system for tissue ligation is provided with a rotating spool assembly, a valve assembly, a wire, and a release cord. The rotating spool assembly has a hub and a spool, with an opening being formed in the hub. The valve assembly has a mating stem member. A lumen extends through a longitudinal center of the mating stem member and aligns on a proximal end of the mating stem member with the opening in the rotating spool assembly. The valve assembly is coupled to a distal end of the rotating spool assembly. The wire has a cross sectional dimension that does not exceed the lumen of the valve assembly, and hooks are formed on each end of the wire. The release cord has a braided cord with first and second single filaments. The single filaments are braided together at a proximal end of the braided cord and separated at a distal end of the braided cord. A plurality of beads are formed along a length of each of the first and second single filaments at the distal end of the braided cord. 
         [0015]    The system can vary in any number of ways. For example, the plurality of beads can be positioned such that no two beads are at a same distance from the proximal end of the braided cord. As another example, the spool can have a substantially hook-shaped member on a surface thereof, and a proximal end of the release cord can be attached to the substantially hook-shaped member. 
         [0016]    As another aspect, a method for assisting with tissue ligation is provided. The method includes passing a loading member having a wire with a hook formed on at least a distal end through an opening in a rotating spool assembly having a spool, distally along a lumen formed in a valve assembly coupled to the rotating spool assembly, and distally along a length of a working channel of an endoscope such that the hook protrudes from a distal end of the working channel. The method also includes securing a proximal end of a release cord onto the hook. The release cord has a braided cord with at least two single filaments, and the single filaments are separated at a distal end of the braided cord and having a plurality of beads formed along a distal length of each of the single filaments. The method additionally includes drawing the proximal end of the release cord proximally through the working channel, the valve assembly, and the rotating spool assembly until the proximal end of the release cord protrudes from a proximal end of the rotating spool assembly. The method further includes attaching the proximal end of the release cord to the spool of the rotating spool assembly. 
         [0017]    The method can vary in any number of ways. For example, the plurality of beads on the single filaments of the release cord can be positioned such that no two beads are at a same distance from the proximal end of the braided cord. The method can also further include wrapping a plurality of ligation bands around an outside distal surface of the endoscope, with each ligation band being positioned in front of corresponding sets of beads on each of the single filaments. As another example, the method can include positioning a distal end of the endoscope against a tissue to be ligated, and retracting the release cord proximally by rotating the spool such that one ligation band is applied to the tissue as the corresponding beads on each single filament are withdrawn into the working channel of the endoscope. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    This invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which: 
           [0019]      FIG. 1  shows an embodiment of a mechanical device. 
           [0020]      FIG. 2  shows an embodiment of a mechanical device. 
           [0021]      FIG. 3  shows an exploded view of an embodiment of a rotating spool assembly. 
           [0022]      FIG. 4  shows an exploded view of an embodiment of a disposable valve assembly. 
           [0023]      FIG. 5  shows an embodiment of a mechanical device in operation with an endoscope. 
           [0024]      FIG. 6  shows an embodiment of a mechanical device. 
           [0025]      FIGS. 7-9  show embodiments of a mechanical device with a spool. 
           [0026]      FIGS. 10-16  show embodiments of an accessory. 
           [0027]      FIGS. 17-21  show an embodiment of a second accessory. 
           [0028]      FIG. 22  shows an embodiment of a release cord. 
           [0029]      FIGS. 23-24  show examples of multi-band ligation devices. 
       
    
    
     DETAILED DESCRIPTION 
       [0030]    Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. 
         [0031]    Further, in the present disclosure, like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the anatomy of the subject in which the systems and devices will be used, the size and shape of components with which the systems and devices will be used, and the methods and procedures in which the systems and devices will be used. 
         [0032]    In general, a mechanical device for coupling to an access device, such as an endoscope, is provided. The mechanical device can be provided as an add-on kit for attachment to an endoscope or other access device just prior to or during surgery, and the mechanical device can be configured to apply one or more ligation bands to tissue to be ligated.  FIG. 1  illustrates one exemplary embodiment of a mechanical device  1  (see  FIG. 1 ) that can be inserted into the accessory port of an endoscope. As shown, the mechanical device  1  includes a control handle for conducting a multi-band ligation procedure. 
         [0033]    In one embodiment, the mechanical device includes a rotating spool assembly  2  and a disposable valve assembly  3  (see  FIGS. 1-3 ). The rotating spool assembly  2  can be configured to be a re-usable element, wherein the components can be formed from specific materials (such as surgical grade stainless steel, titanium, or other metals) and assembled in such a way to enable sterilization and use with a plurality of patients. The disposable valve assembly  3  can include a mating stem member  4  (with an upper body  7 ), a sealing member  5 , a flushing port member  6 , and a tip  11 . The upper body  7  of the mating stem member  4  includes tabs  15  (see  FIG. 6 ). These elements are combined into an assembly that can be formed as a single disposable entity. The flushing port member  6  may have a luer taper, allowing fluid fittings to make leak-free connections between mating taper-fitting-parts. 
         [0034]    The means through which the disposable valve assembly  3  and rotating spool assembly  2  are attached can allow for rapid assembly and disassembly. In an exemplary embodiment, attachment can be achieved via insertion and rotation of the disposable valve assembly  3  into the rotating spool assembly  2 , for example using a quarter turn bayonet fitting (see  FIGS. 2 and 6 ). 
         [0035]    The disposable valve assembly  3  and the rotating spool assembly  2  may also be rigidly attached to each other through mechanical means so that the disposable valve assembly  3  and rotating spool assembly  2  are treated as a single entity and disposed of after single patient use (see  FIG. 1 ). 
         [0036]    Also provided herein is a mating stem member  4 . The mating stem member  4  can be shaped to mate with an endoscope accessory port. For example, a taper on the insertion stem  8  can be provided to allow the tapered geometry to form a surface-to-surface mate with the internal geometry of an endoscope accessory port, upon insertion to an endoscope (see  FIGS. 4-5 ). The elongated portion above the tapered portion can also be engineered to be long enough so that it accommodates the height of all endoscopic caps currently on the market without detriment to the surface-to-surface mate with the internal geometry. 
         [0037]    The rotating spool assembly  2  can include a hub  16  with an arm  12 . This enables the easy removal of the release cord  201  by counter-clockwise unravelling along the axis of the rotating spool  9  and provides an open design to increase access to the rotating spool assembly  2  (see  FIGS. 1, 3, and 17 ). 
         [0038]    In an exemplary embodiment, the rotating spool assembly  2  features a hooking member  10  on the central rotating section of the spool  9 . This hooking member  10  can mate to the loop member  209  of the release cord  201  of the multi-band ligation device and is an exemplary embodiment of the functionality which allows a multitude of different coupling methods to be utilized, if so desired (see  FIGS. 2, 3, and 17 ). The spool  9  can be rotated to draw the release cord  201  up through the working channel of the endoscope and wrap around the spool  9 . The rotating spool assembly  2  can also include an end cap  17 , a circlet  21 , a washer  20 , a clutch  13 , O-rings  19 ,  18 , a cylinder  14 , and a receiver  16  (see  FIGS. 3 and 6 ). 
         [0039]    An alternate embodiment for attaching the release cord  201   b  to the spool  9   b  is for the spool  9   b  to incorporate a tapered toothed groove  10   b  such that, on drawing the release cord  201   b  into the groove, it is gripped and held securely (see  FIG. 7 ). 
         [0040]    Another embodiment for attaching the release cord  201   b  to the spool  9   c  is for the spool  9   c  to incorporate two or more posts  10   c  such that wrapping the release cord around said posts  10   c  in a figure of eight causes the release cord  201   b  to be held by friction (see  FIG. 8 ). 
         [0041]    Another embodiment for attaching the release cord  201   b  to the spool  9   d  is for the spool  9   d  to incorporate a single post  10   d  and the spool  9   d  a slot such that wrapping the cord  201   b  around the post  10   d  aligns the cord  201   b  and fitting the cord into the spool  9   d  slot retains the cord  201   b  (see  FIG. 9 ). 
         [0042]    An accessory or instrument is also provided to be used in conjunction with a multi-band ligation device  1 . This accessory is presently provided as a loading wire  101  that facilities the loading of the ligation band release cord, from the distal end of the working channel of a flexible endoscope to the proximal end of the working channel, until it exits through the accessory port of said endoscope, at which point the release cord may couple with the rotating spool of a multi-band ligation device handle (see  FIG. 10 ). The loading wire  101  may be passed down the working channel from the accessory port to the distal end of the endoscope. The release cord  201  can be hooked on the loading wire  101 , at which point the loading wire  101  can be withdrawn up the working channel. The release cord  201  can then be drawn up the working channel from the distal end to the proximal end attached to the loading wire. 
         [0043]    The simplicity of construction and manufacture of the loading wire  101  can be beneficial to the user. The loading wire  101  may be formed from a single piece of metallic wire that is post-formed to give it added functionally and improvements not seen in any similar devices. 
         [0044]    One advantage is the coiled configuration  102  of the wire (see  FIGS. 10-11 ). The metallic wire is post formed into a coiled shape  102  which adds benefits in terms of ease of handling and control for the operator. Because of the functionally of traveling through the working channel of endoscopes, the loading wire  101  needs to be very long, which can make handling and control of the loading wire  101  very difficult for the operator. By its very nature a coiled configuration  102  is much easier to handle and control and makes the process more manageable for the operator. Once the loading wire  101  is inserted into the endoscope working channel the coiled configuration  102  no longer becomes an issue as the loading wire  101  takes the shape of the working channel. On removal the loading wire  101  then returns to its coiled configuration  102 , and this can present several safety benefits for the user. For example, the coiled configuration can prevent the wire from jumping into the visual field of the user and/or assistant. The coiled configuration is also less likely to contact the floor or other unclean surfaces during the loading process. Finally, if the loading wire is put down onto the small accessory tables and is needed to re-load the device for more band placements, it is much more likely to remain in place in a tight coil on the small accessory stand. 
         [0045]    In an exemplary embodiment, the loading wire  101  incorporates straight sections  104  at the ends of the wire, to enable ease of entry into the endoscope working channel (see  FIG. 10 ). Alternately the loading wire  101   b  could be formed as a complete coiled component without straight ends (see  FIG. 11 ). 
         [0046]    A hook-like configuration  103  can be integrated on either or both ends of the loading wire  101  (see  FIG. 12 ). The hook-like configuration  103  can be formed from the same single piece of wire, meaning any possibility of detachment of the hook component  103  is removed, which greatly adds to user confidence and increases patient safety. The hook-like configuration  103  can also be shaped to ensure that the possibility of the hook  103  catching on or snagging and damaging other medical equipment is drastically reduced given its low-profile design. The ends may also be formed into additional configurations (see  FIGS. 13-16 ). 
         [0047]    There is also a secondary accessory or instrument to be used in conjunction with a multi-band ligation device  1 . The accessory is presently defined as a release cord  201  which facilitates the release of elastic ligation bands (see  FIG. 17 ). The release cord  201  travels from the distal end of the working channel of a flexible endoscope to the proximal end of the working channel, until it exits through the accessory port of said endoscope at which point the release cord  201  may couple with the rotating spool  9  of a multi-band ligation device handle. 
         [0048]    The cord can also include beads  203 - 208  positioned in pairs, with one bead  203 - 208  on each filament  202 , spaced at set intervals along the length of the single filament  202  (see  FIGS. 17-18 ). The pairs of beads  203 - 208  can be configured in a staggered and offset configuration, so the beads  203 - 208  are not positioned side-by-side (see  FIG. 19 ). This means that, when the beads  203 - 208  are pulled inside the working channel, no two beads  203 - 208  will be side by side and occlude the working channel of the endoscope. The fact they are offset and staggered can reduce the possibility of the working channel becoming occluded. The more space that is available in the accessory channel during or after banding will increase the options for devices placed subsequently. Variously shaped beads may also be used (see  FIGS. 20-21 ). 
         [0049]    Ligation bands can be placed around the outside distal end of the endoscope in front of sets of the beads  203 - 208 . The release cord  201  can be withdrawn up the working channel of the endoscope, which can cause the beads  203 - 208  to be withdrawn around the distal end of the endoscope. The ligation bands can be caused by the beads  203 - 208  to be pushed distally off of the distal end of the endoscope, thereby applying the band to the tissue drawn into the endoscope. 
         [0050]    In one embodiment, there is a looped nature  209  to the proximal end of the release cord  201  (see  FIGS. 17 and 22 ). Having a closed loop configuration  209  at the proximal end of the cord  201  allows for a variety of attachment methods to any number of coupling modalities. It also ensures that these couplings will be safe and secure, which adds to operator confidence and results in better outcomes for patients through faster and more efficient procedures. These are procedures that are done in high stress conditions and in units where the light is usually very low in order to read the monitors involved. 
         [0051]    One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.