Patent Publication Number: US-2022233190-A1

Title: Method for closing a wound

Description:
RELATED APPLICATION DATA 
     This application is based on and claims priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 63/142,592, filed Jan. 28, 2021, the entire contents of which are incorporated herein by reference. 
    
    
     FIELD 
     The present disclosure, in certain embodiments, provides methods and apparatuses for resecting a lesion in a wall of an organ of a patient. In further embodiments, the present disclosure relates to methods and apparatuses for closing a wound. In some embodiments, methods and apparatuses of the present disclosure may be used to close wounds in the mucosal layer of a luminal organ of a patient. In some embodiments, methods and apparatuses of the present disclosure may be used to close wounds resulting from mucosectomy. 
     BACKGROUND 
     Mucosectomy is a surgical procedure that involves excising a portion of the mucous membrane from an organ of a patient, particularly along the gastrointestinal (GI) tract. Mucosectomy may be used, for example, to remove neoplasms, tumors, or other lesions from the internal wall of a luminal organ (e.g., esophagus, stomach, small intestine, colon, etc.). Two example mucosectomy techniques are endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), each of which utilize endoscopy to excise certain lesions. EMR may be used to remove lesions located near the wall surface in the mucosa layer, whereas ESD may be suitable for removing deeper lesions that have not extensively penetrated the muscle layer of the organ wall. 
     Methods for EMR and/or ESD can generally include elevating the lesion away from the muscle layer, followed by resection of the elevated lesion. In some instances, elevating the lesion away from the muscle layer is achieved by injecting a bolus of fluid (e.g., a saline solution) into the submucosa beneath the lesion sufficient to separate the lesion from the muscle layer. For certain EMR procedures, resection may include positioning and tightening a snare loop around the elevated lesion and resecting the strangulated lesion using, for example, electrocautery. For certain ESD procedures, resection of the lesion may include circumferential cutting of the surrounding mucosa of the lesion and dissection of the connective tissue of the submucosa beneath the lesion. 
     Whether by EMR, ESD, or other mucosectomy procedure, the resection of the lesion creates a wound in the mucosal and/or submucosal layers where the lesion has been removed. The wound may be left open and allowed to heal on its own, however, this route presents a risk of infection and/or bleeding, and may be an unacceptable option for certain patients, such as patients receiving antithrombotic drugs or blood thinning agents. Thus, in other instances, it may be desirable to close the wound. 
     For some procedures, surgical clips may be employed to close the wound. Surgical clips, however, are limited by their size and therefore may be suitable only for closing relatively small wounds. Wounds may alternatively be closed by suturing. Such suturing techniques may include, for example, passing a suture thread between the mucosa layer on opposing sides of the wound, and tightening the suture thread in order to draw the opposing sides together to close the wound. However, it has been found that typical suturing techniques may suffer from certain drawbacks. 
     SUMMARY 
     A potential difficulty encountered with suturing the wound is the loosening of the suture thread over time, which may allow the wound to reopen. Reopening of the wound, even partially, can increase the risk for bleeding, infection, or other complications. Such loosening may occur, for example, if the tissue surrounding the wound changes shape to an extent that causes the suture thread to shift in position and/or slacken. Loosening of the suture thread can be a particular problem for wounds resulting from an EMR or ESD procedure since the mucosal and/or submucosal layers around the wound will contract as the fluid injected to elevate the lesion prior to resection dissipates from the wound site and/or is absorbed by the patient&#39;s body. 
     The present disclosure, according to some embodiments, provides methods for closing a wound that can overcome the problems discussed above. In some embodiments, a method of the present disclosure includes removing at least a portion of the fluid injected during a mucosectomy procedure (e.g., EMR or ESD procedures) prior to closing the resulting wound. In some embodiments, the removal of the injected fluid may occur before introducing a suture thread to close the wound. In some embodiments, removal of the injected fluid may occur after introduction of the suture thread, but prior to tightening of the suture thread to close the wound. In some embodiments, the injected fluid may be removed via suctioning by a hollow needle inserted into the tissue surrounding the wound. A syringe or other pumping device may be connected to a proximal end of the hollow needle that is configured to suction the fluid through the hollow needle. In further embodiments, the present disclosure provides a device that may be useful in the methods described herein. In some embodiments, the device includes both a hollow needle for suctioning the fluid and forceps for holding and manipulating a suture thread. 
     In some embodiments, the present disclosure provides methods for resecting a lesion in a wall of an organ of a patient. A method according to some embodiments includes injecting a fluid into the wall of the organ at a location proximate to the lesion, creating a wound in the wall of the organ by excising the lesion from the wall of the organ, removing at least a portion of the fluid injected into the wall of the organ, and closing the wound using a suture thread after removing the portion of fluid injected into the wall of the organ. In some embodiments, the lesion is located in a mucosal layer of the wall of the organ, and at least a portion of the fluid is injected into the wall of the organ beneath the lesion. In some embodiments, injecting the fluid elevates the lesion away from a muscle layer of the wall of the organ. In some embodiments, removing at least a portion of the fluid comprises removing at least  50 % of the fluid injected into the wall of the organ. 
     In some embodiments, removing at least a portion of the fluid comprises inserting a distal end of a hollow needle into the wall of the organ, and suctioning the portion of the fluid from the wall of the organ through the hollow needle. A suctioning device (e.g., a syringe or pump) may be coupled to a proximal end of the hollow needle. In some embodiments, the hollow needle extends from a distal end of a device, the distal end of the device further comprising forceps configured to manipulate the suture thread. In some such embodiments, a proximal end of the device includes a control handle configured to transition the forceps between an open position and a closed position. 
     In some embodiments, prior to removing the portion of the fluid injected into the wall of the organ, the suture thread is threaded into the wall of the organ at a first position on a first side of the wound. In some embodiments, the suture thread is also threaded into the wall of the organ at a second position located on a second side of the wound opposite from the first side of the wound. In some embodiments, threading the suture thread into the wall of the organ at the second position occurs prior to removing the portion of the fluid injected into the wall of the organ. In some embodiments, threading the suture thread into the wall of the organ at the second position occurs after removing the portion of the fluid injected into the wall of the organ. In some embodiments, a method according to the present disclosure includes removing a second portion of the fluid injected into the wall of the organ after threading the suture thread into the wall of the organ at the second position. In other embodiments, removing at least a portion of the fluid injected into the wall of the organ occurs prior to threading the suture thread into the wall of the organ. 
     In further embodiments, the present disclosure provides a device for closing a wound. A device for closing a wound according to some embodiments includes an elongated shaft having a distal end and a proximal end, a hollow needle extending from the distal end of the shaft, the hollow needle having a distal end configured to be inserted into a tissue of a patient and a proximal end configured to be connected to a suctioning device (e.g., a syringe or pump). In some embodiments, the device further includes forceps positioned at the distal end of the shaft having an arm movable between an open configuration and a closed configuration, and a control handle positioned at the proximal end of the shaft, the control handle configured to transition the arm of the forceps between the open configuration and the closed configuration. In some embodiments, the arm is configured to hold a suture needle in the closed configuration. In some embodiments, the device further includes a mechanical linkage housed within the shaft connecting the control handle to the forceps. In some embodiments, the device includes a valve fitting in fluid communication with the proximal end of the hollow needle, the valve fitting configured to connect to the suctioning device. In some embodiments, the distal end of the hollow needle is retractable within the shaft. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing summary, as well as the following detailed description, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, there are shown in the drawings embodiments which are presently preferred, wherein like reference numerals indicate like elements throughout. It should be noted, however, that aspects of the present disclosure can be embodied in different forms and thus should not be construed as being limited to the illustrated embodiments set forth herein. The elements illustrated in the accompanying drawings are not necessarily drawn to scale, but rather, may have been exaggerated to highlight the important features of the subject matter therein. Furthermore, the drawings may have been simplified by omitting elements that are not necessarily needed for the understanding of the disclosed embodiments. 
         FIGS. 1A-1F  illustrate steps for resecting a lesion from the wall of an organ of a patient according to certain example methods. 
         FIGS. 2A-2D  illustrate a suturing method for closing a wound created by resecting a lesion from the wall of an organ, according to certain embodiments. 
         FIGS. 3A-3F  illustrate the closing and reopening of a wound caused by fluid remaining in the surrounding tissue according to certain embodiments. 
         FIGS. 4A-4F  illustrate the removal of fluid from the tissue surrounding the wound prior to closing the wound with suturing according to certain embodiments. 
         FIGS. 5A-5F  illustrate the removal of fluid from the tissue surrounding the wound prior to closing the wound according to certain embodiments. 
         FIGS. 6A and 6B  are photographs showing an example suture and suture needle that may be used according to certain embodiments. 
         FIG. 7  shows a device having a combination of forceps for manipulating a suture and a hollow needle for suctioning of fluid from tissue that may be useful in the methods described herein according to certain embodiments. 
     
    
    
     DETAILED DESCRIPTION 
     The present subject matter will now be described more fully hereinafter with reference to the accompanying Figures, in which representative embodiments are shown. The present subject matter can, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to describe and enable one of skill in the art. 
       FIGS. 1A-1F  illustrate steps of a mucosectomy procedure according to certain examples for resection of a lesion from an organ wall of a patient. The mucosectomy procedure may include, for example, an EMR procedure or an ESD procedure. The patient may be a human patient, or a non-human animal patient (e.g., a veterinarian patient).  FIG. 1A  shows a lesion  100  on a wall  102  of an organ of a patient, for example, a luminal organ of the GI tract (e.g., esophagus, stomach, small intestine, colon, etc.). Lesion  100  may be, for example, a benign tumor, cancerous tumor, or other abnormal growth that is present on the mucosa layer of wall  102 . As further illustrated in  FIG. 1A , a marking tool  202  (e.g., an endoscopic electric coagulator or cauterizer) may be used to create one or more markings  104  around lesion  100  in order to demarcate the boundary of lesion  100  for resection. 
     In  FIG. 1B , an injection tool  204  (e.g. an endoscopic injection needle) is used to inject a fluid  206  into wall  102  beneath lesion  100 . Fluid  206  may be an aqueous solution, for example, a saline solution or a hyaluronic acid solution. In some embodiments, fluid  206  is or includes a gel (e.g., hydrogels, thermogels, hydroxypropyl methylcellulose, poloxamer, etc.). Fluid  206  may further contain one or more pharmaceutically active agents (e.g., epinephrine). Fluid  206  may be injected into the submucosal layer of wall  102  beneath lesion  100 , and may be injected through one or more injection sites around lesion  100 . The amount of fluid  206  that is injected should be sufficient to elevate lesion  100  away from the muscle layer of wall  102  and cause lesion  100  to physically bulge from wall  102 . In some embodiments, endoscopic images of lesion  100  and the surrounding tissue may be viewed to confirm sufficient elevation and bulging. The presence of wrinkles, for example, may indicate that bulging is insufficient and that additional fluid  206  may be needed. In some examples, about 40 mL to about 50 mL of fluid  206  may be administered via four or five syringes, each syringe containing about 10 mL of fluid  206 . The amount of fluid  206  that is injected may be less or greater in other examples, depending on the size of lesion  100   
     After lesion  100  is sufficiently elevated, lesion  100  may be excised from wall  102  as depicted in  FIGS. 1C and 1D . A cutting tool  208  (e.g., an endoscopic electrosurgical knife) may be used to cut into the mucosal layer and/or submucosal layer of wall  102  around lesion  100 . In some examples, cutting tool  208  is used to make a circumferential cut in the mucosal layer of wall  102  guided by or around the one or more markings  104 . Dissection of connective tissues of the submucosa beneath lesion  100  may also be performed by cutting tool  208  in order to fully resect lesion  100  from wall  102 . 
       FIG. 1E  shows lesion  100  completely resected from wall  102 . Lesion  100  may then be removed from the patient&#39;s body for pathological examination or disposal. The removal of lesion  100  leaves a wound  108  in wall  102  where lesion  102  was resected. Wound  108  may extend as deep as the mucosal layer or the submucosal layer of wall  102  according to some examples. Following removal of lesion  100 , wound  108  may be closed to prevent bleeding, infection, or other complications. As shown in FIG. IF, in some examples one or more surgical clips  210  may be employed to close wound  108 . As discussed, surgical clips  210  may be suitable for wounds that are relatively small in size. Thus, in some embodiments, wound  108  may alternatively be closed by suturing with a suture thread, as depicted in  FIGS. 2A-2D , for example. 
     As shown in  FIG. 2A , a suture thread  212  is provided for closing wound  108 . Suture thread  212 , in some embodiments, may be an absorbable suture thread and have a gauge of USP 3-0 or about 0.2 mm diameter, for example. In some embodiments, suture thread  212  may be a barbed suture thread. At a first end of suture thread  212  is a suture needle  214  for piercing the mucosal layer of wall  102  and guiding suture thread  212  there through. 
     Suture needle  214  may be, for example, a curved needle and may be manipulated by an endoscopic needle holder or forceps (not shown). A second end of suture thread  212  may be anchored in wall  102  at a first location  110  proximate to wound  108 , for example, by one or more knots. In some embodiments, second end of suture thread  212  may include an eyelet through which suture needle  214  and the first end of suture thread  212  may be passed to form a loop for anchoring around a portion of the mucosa at first location  110 . 
     To suture wound  108 , in some embodiments, suture thread  212  is passed through the mucosal layer of wall  102  back and forth between opposite sides of wound  108  beginning from location  110 , as illustrated in  FIGS. 2B and 2C . Suture thread  212  may then be pulled tight to draw the opposing sides of wound  108  closed, and suture thread  212  may be anchored at a second location  112  in wall  102 , e.g., by one or more knots, in order to prevent suture thread  212  from backing out. In some embodiments, wound  108  may be closed with a continuous stitch. In other embodiments, wound  108  may be closed by a series of separate stitches. Once the suturing is completed, suture needle  214  may be detached from suture thread  212 , for example, by cutting suture thread  212  with a cutting tool (e.g., endoscopic cutting forceps) at a location between suture needle  214  and second location  112 , as shown in  FIG. 2D . 
     As discussed, a problem that may be encountered is that the suture thread can loosen over time, allowing the wound to reopen. This loosening may occur, for example, when the mucosal and/or submucosal layers surrounding the wound changes shape and causes the suture thread to shift in position. In some instances, as fluid  206  that is injected to elevate the lesion dissipates from the wound site and/or is absorbed by the patient&#39;s body, the tissue surrounding the wound may begin to contract and cause the suture thread to slacken. As a result, the wound may reopen leading to complications such as bleeding, infection, or other negative conditions. 
       FIGS. 3A-3F  illustrate one effect that may arise from loosening of a suture thread in one such example.  FIGS. 3A and 3B  show wound  108  prior to closure by suture thread  212 . As shown, a portion of injected fluid  206  (e.g., saline solution) remains in the mucosal and/or submucosal layers of wall  102  surrounding wound  108 .  FIGS. 3C and 3D  depict wound  108  being closed by suture thread  212  with fluid  206  still present in the surrounding tissues of wall  102 . As fluid  206  dissipates and/or is absorbed by the patient&#39;s body, the tissue around wound  108  may contract causing wound  108  to at least partially reopen, as shown in  FIGS. 3E and 3F . 
     In order to avoid or decrease the possibility of the suture thread becoming loosened, methods according to embodiments of the present disclosure further include removing at least a portion of the injected fluid (e.g., fluid  206 ) prior to closing the wound. In some embodiments, removal of at least a portion of fluid  206  prior to closing the wound decreases the amount by which the tissues surrounding wound  108  may change shape after the wound is closed as a result of fluid  206  dissipating from the wound area or being absorbed by the patient&#39;s body. In some embodiments, at least a portion of fluid  206  is removed prior to inserting the suture thread into the tissue surrounding the wound. In some embodiments, at least a portion of fluid  206  is removed after inserting the suture thread into the tissue surrounding the wound, but prior to completing the stitching and/or prior to tightening the suture thread to close the wound. In some embodiments, fluid  206  may be removed by aspirating or suctioning fluid  206  from wall  102  after lesion  100  has been resected. In some embodiments, a needle is provided having a distal end configured to be inserted into wall  102  to remove fluid  206  from wall  102 . In some embodiments, a suctioning device (e.g., syringe or other pump) may be connected to a proximal end of the needle and configured to suction fluid  206  from wall  102  through the needle. 
       FIGS. 4A-4F  illustrate steps of a method according to some embodiments of the present disclosure where at least a portion of fluid  206  is removed from wall  102  prior to retracting the suture thread so as to bring portions of the boundary of the wound into contact with each other and closing wound  108 . As shown in,  FIGS. 4A and 4B  suture thread  212  is passed at least once through opposing regions of wound  108  while some amount of fluid  206  remains in the mucosal and/or submucosal layers of wall  102  surrounding wound  108 . In  FIGS. 4C and 4D , after inserting suture thread  212 , but prior to completely closing wound  108  with suture thread  212 , at least a portion of fluid  206  is removed from wall  102 . In some embodiments, a portion of fluid  206  may be removed from wall  102  in multiple steps. In some such embodiments, for example, a portion of fluid  206  may be removed after each pass of suture thread  212  between opposing sides of wound  108 . 
     In some embodiments, prior to removing the portion of fluid  206 , suture thread  212  is threaded into wall  102  at a first position on a first side of wound  108  (e.g., location  110 ). In some embodiments, suture thread  212  is further threaded through wall  102  at a second position  114  located on a second side of the wound opposite from the first side of the wound. In some embodiments, a first portion of fluid  206  may be removed from wall  102  before suture thread is threaded into wall  102  at second position  114 , and a second portion of fluid  206  may be removed after suture thread is threaded into wall  102  at second position  114 . In other embodiments, suture thread  212  may be threaded into first position (e.g., location  110 ) and second position  114  prior to removing any of fluid  206 . 
     In some embodiments, fluid  206  is removed using a hollow needle  216  having a distal end that is inserted into one or more regions of wall  102  surrounding wound  108  and positioned to suction at least a portion of fluid  206  out of wall  102 . In some embodiments, a proximal end of hollow needle  216  may be coupled to a syringe or other suctioning device (not shown) for supplying the suctioning force to draw fluid  206  out of wall  102  via hollow needle  216 . In some embodiments, as much fluid  206  is removed from wall  102  as possible before closing wound  108 . In some embodiments, at least 25% to at least 50% of the amount of fluid  206  that was injected into wall  102  is removed prior to closing wound  108 . In some embodiments, at least 50% to at least 75% of the amount of fluid  206  that was injected into wall  102  is removed prior to closing wound  108 . After fluid  206  has been removed from the tissue, hollow needle  216  is withdrawn and suture  212  may be pulled tight to draw the opposing regions of wound  108  together and close wound  108 , as depicted in  FIGS. 4E and 4F . 
     In other embodiments, fluid  206 , or a portion thereof, may be removed from wall  102  prior to introducing suture thread  212 , as shown  FIGS. 5A-5F . As illustrated in  FIGS. 5A and 5B , fluid  206  is removed using a hollow needle  216  before suture thread  212  is passed at least once through opposing regions of wound  108  (e.g., as described herein). As discussed in prior embodiments, hollow needle  216  may include a distal end that is inserted into one or more regions of wall  102  surrounding wound  108  and positioned to suction at least a portion of fluid  206  out of wall  102 . A proximal end of hollow needle  216  may be coupled to a syringe or other suctioning device (not shown) for supplying the suctioning force to draw fluid  206  out of wall  102  via hollow needle  216 . In some embodiments, as much fluid  206  is removed from wall  102  as possible before suturing wound  108 . In some embodiments, at least  25 % to at least  50 % of the amount of fluid  206  that was injected into wall  102  is removed prior to suturing wound  108 . In some embodiments, at least 50% to at least 75% of the amount of fluid  206  that was injected into wall  102  is removed prior to suturing wound  108 . After a sufficient amount of fluid  206  has been removed from wall  102 , hollow needle  216  may be withdrawn and suture thread  212  is passed between opposing regions of wound  108  (e.g., from location  110  to position  114 ), as shown in  FIGS. 5C and 5D . In  FIGS. 5E and 5F , suture thread  212  is pulled tight to draw the opposing regions of wound  108  together to contact each other and close wound  108 . 
       FIG. 6A  shows an example suture thread  212  and suture needle  214  that may be used in accordance with some or each of the embodiments of the present disclosure. Suture thread  212  may be made from an bio-absorbable material and, in some embodiments, may include a plurality of barbs (visible in  FIG. 6B ) that are configured to help anchor suture thread  212  in wall  102  and reduce the need for tying knots. In further embodiments, suture thread  212  may include an eyelet  212 a at the end opposite of suture needle  214 . In some such embodiments, suture needle  214  may be passed through eyelet  212 a to form a loop that may be used for anchoring suture thread  212  to wall  102 . 
     In some embodiments, the hollow needle for suctioning fluid  206  may be combined with a suturing tool in a single device. In some embodiments, such a device may be conveniently used for performing both the removal of fluid  206  and the suturing of wound  108 . One such example device is illustrated in  FIG. 7  and generally designated  300 . Device  300  may be configured for endoscopic use according to some embodiments and includes an elongated shaft having a distal end  302  sized to be inserted into the body of a patient. In some embodiments, device  300  includes forceps  304  located at distal end  302  and configured for holding and manipulating a suture needle (e.g., suture needle  214 ). Forceps  304  may include a movable arm configured to hold or clamp the suture needle, which may be controlled by a control handle  306  located at a proximal end of device  300 . Control handle  306  may operate to open or close forceps  304  by causing the movable arm to pivot between open and closed positions. For example, in some embodiments, control handle  306  may be connected to the movable arm by a mechanical linkage  314  housed within the shaft that is configured to transmit mechanical force or energy from control handle  306  to forceps  304 , e.g., a rod or Bowden cable. 
     Device  300 , in some embodiments, further includes a hollow needle  308  extending from distal end  302  and configured to be inserted into the tissue of the patient. Hollow needle  308  may be used similarly as hollow needle  216  described previously to suction fluid away from the tissue (e.g., fluid  206 ). In some embodiments, hollow needle  308  is at least partially housed within the shaft of device  300  and includes a distal end configured to be inserted into wall  102  and a proximal end opposite the distal end configured to be in fluid communication with a suctioning device (e.g., syringe or pump). In some embodiments, the proximal end of hollow needle  308  may be in fluid communication with tubing  310  and fitting  312  at the proximal end of device  300 . Fitting  312  may include, for example, a valve or cock and be configured to attach to a syringe or other suctioning device for drawing fluid through hollow needle  308 . In some embodiments, distal end of hollow needle  308  may be retracted into the shaft of device  300  when not in use. 
     While certain embodiments of the present disclosure have been described in connection with certain EMR or ESD procedures, the methods and devices described herein are not necessarily limited to these procedures. Methods and devices according to some embodiments that are useful for closing wounds may be adapted for use with other mucosectomy procedures or other medical procedures which result in a wound. Furthermore, the methods and devices described herein are not necessarily limited for use in the GI tract of a patient, and may be adapted for use in other luminal organs, for example, organs of the respiratory system (e.g., trachea), circulatory system (e.g., veins or arteries), urinary tract (e.g., bladder), reproductive tract (e.g., uterus), etc. 
     It should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. It should also be apparent that individual elements identified herein as belonging to a particular embodiment may be included in other embodiments of the invention. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, and composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure, processes, machines, manufacture, composition of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be used according to the present disclosure.