Patent Publication Number: US-2023149621-A1

Title: Medical treatment systems and related methods thereof

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of priority from U.S. Provisional Application No. 62/982,206, filed on Feb. 27, 2020, which is incorporated by reference herein in its entirety. 
    
    
     TECHNICAL FIELD 
     This disclosure relates generally to medical treatment systems, devices, and related methods thereof. Embodiments of the disclosure relate to endoluminal wound treatment systems, and medical devices for negative pressure wound therapy. 
     BACKGROUND 
     Endoscopic and open surgical procedures of the gastrointestinal (GI) tract include, for example, colonic resection, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy, among others. These procedures may result in perforation, post-surgical leaks, or other wounds of the tract. Limited treatment options exist for managing such wounds, which have significant morbidity and mortality rates. Options include surgical re-operation and endoscopic placement of a stent or clips. Surgery is relatively invasive and also has high morbidity and mortality rates. Endoscopic stent placement is a less invasive option. The placed stent, however, can migrate from the intended location and/or wall off infection at the treatment site, inhibiting drainage. 
     SUMMARY OF THE DISCLOSURE 
     According to an example, a medical system may comprise a compressible device, and a covering over the compressible device, wherein the covering includes a delivery configuration and a deployed configuration, wherein, in the delivery configuration, the covering at least partially covers the compressible device to maintain the compressible device in a compressed state, and wherein, in the deployed configuration, the covering is releasable from the device to transition the compressible device from the compressed state to an expanded state. 
     In another example, the medical system may further comprise a suction tube, wherein the suction tube is connected to a proximal portion of the compressible device, and the suction tube is configured to apply a suction to the compressible device. 
     In another example, the compressible device may be porous and absorbent. 
     In another example, the covering may be a capsule. The capsule may be removable via exposure to a fluid. 
     In another example, the covering may be a netting. The medical system may further comprise a thread or a wire coupled to the netting, wherein the thread or the wire is configured to remove the netting via a force applied to the thread or the wire. The netting may be configured to be removable when the compressible device pushes against a breaking point of the netting. The netting may be configured to be tightened to further compress the compressible device. 
     In another example, the covering may be a membrane. The membrane may be impermeable. The membrane may be configured to compress the compressible device via a vacuum seal. The membrane may be removable via exposure to a fluid. The membrane may be configured to be removable when the compressible device pushes against a breaking point of the membrane. 
     In another example, the covering may completely cover the compressible device. 
     According to another example, a medical system may comprise a compressible device, a covering over the compressible device, a first tube connected to a proximal portion of the compressible device, and a second tube including a lumen containing the first tube, wherein a proximal end of the lumen is configured to be in communication with a suction source, wherein the covering is fixed to a distal portion of the second tube to contain and seal the compressible device within a cavity of the covering, and the covering is configured to collapse onto the compressible device via a suction supplied to the cavity, thereby compressing the compressible device. The covering may be an impermeable membrane. The compressible device may be configured to compress so that the compressible device fits within the lumen of the second tube. The covering may be configured to be removable from the second tube. 
     According to another example, a method of endoluminal wound treatment via a medical device, the medical device including a compressible device, a covering over the compressible device, and a tube connected to the compressible device, may comprise positioning the medical device within a cavity of a wound, removing the covering over the compressible device, and providing a suction throughout the compressible device via the tube. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the disclosed embodiments. 
         FIG.  1    is a side view of a portion of a shaft of an endoscope including a medical device for endoluminal wound treatment, according to an embodiment. 
         FIGS.  2 A- 2 B  are, respectively, perspective and cross-sectional views of a compressed medical device for endoluminal vacuum therapy, according to an embodiment. 
         FIG.  3    is a perspective view of a compressed medical device for endoluminal vacuum therapy, according to another embodiment. 
         FIGS.  4 A- 4 B  are cross-sectional views of a medical device in expanded and compressed states, respectively, for endoluminal vacuum therapy, according to another embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Reference will now be made in detail to aspects of the disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term “distal” refers to a portion farthest away from a user when introducing a device into a subject (e.g., patient). By contrast, the term “proximal” refers to a portion closest to the user when placing the device into the subject. 
     Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. In this disclosure, relative terms, such as, for example, “about,” “substantially,” “generally,” and “approximately” are used to indicate a possible variation of ±10% in a stated value or characteristic. 
     Embodiments of this disclosure include devices, systems, and methods for endoluminal vacuum therapy (EVAC). In examples, EVAC includes endoluminal placement of a sponge or other like material into a wound site, including a perforation, a leak, an anastomosis, etc. Placement of the material may be via a catheter, scope (endoscope, bronchoscope, colonoscope, gastroscope, duodenoscope, etc.), tube, or sheath, inserted into the GI tract via a natural orifice. The orifice can be, for example, the nose, mouth, or anus, and the placement can be in any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Placement also can be in other organs reachable via the GI tract. Then, negative pressure may be delivered to the wound site in the GI tract, via a vacuum source. 
     Furthermore, in embodiments of this disclosure, the sponge of the EVAC devices may be any suitable biocompatible material that may absorb liquids and/or permit liquid to pass therethrough via negative pressure. The material may be flexible, compressible, porous, hydrophilic, sterile, and/or disposable. The sponge material may be an open-cell foam. Suitable materials include polyurethanes, esters, ethers, composite materials, and any medical-grade material. 
     In the embodiments described below, the compressible sponge is in a compressed state, via varying means and mechanisms, e.g., a covering, a membrane, etc. This is so that the compressed sponge may be more easily deliverable through a working channel of a scope, and through a natural body lumen of a subject. The covering is configured to be releasable or removable in any suitable manner, e.g., sheared, broken, dissolved/degraded, so that the compressed sponge may deploy and expand once delivered to a targeted site. 
     Referring to  FIG.  1   , a medical system  5  including a scope, e.g., an endoscope, according to an embodiment is shown. Medical system  5  includes a flexible shaft  50  (e.g., a catheter) and a handle  52  connected at a proximal end of flexible shaft  50 . Handle  52 , or some other device for actuating or controlling medical system  5  and any tool or devices associated with medical system  5 , includes first and second actuating devices  42 ,  43 , which control articulation of flexible shaft  50 , and/or an articulation joint at a distal end of flexible shaft  50 , in multiple directions. Devices  42 ,  43 , may be, for example, rotatable knobs that rotate about their axes to push/pull actuating elements (not shown). The actuating elements, such as cables or wires suitable for medical procedures (e.g., medical grade plastic or metal), extend distally from a proximal end of medical system  5  and connect to flexible shaft  50  to control movement thereof. Alternatively, or additionally, a user may operate actuating elements independently of handle  52 . Distal ends of actuating elements may extend through flexible shaft  50  and terminate at an articulation joint and/or a distal tip of flexible shaft  50 . For example, one or more actuating elements may be connected to an articulation joint, and actuation of actuating elements may control the articulation joint or the distal end of flexible shaft  50  to move in multiple directions. 
     In addition, one or more electrical cables (not shown) may extend from the proximal end of system  5  to the distal end of flexible shaft  50  and may provide electrical controls to imaging, lighting, and/or other electrical devices at the distal end of flexible shaft  50 , and may carry imaging signals from the distal end of flexible shaft  50  proximally to be processed and/or displayed on a display. Handle  52  may also include ports  54 ,  46  for introducing and/or removing tools, fluids, or other materials from the patient. Ports  54  and/or  46  may be used to introduce tools. Ports  54  and/or  46  may also be connected to an umbilicus for introducing fluid, suction, and/or wiring for electronic components. For example, as shown in  FIG.  1   , port  54  receives a tube  100 , which extends from the proximal end to the distal end of flexible shaft  50 , via a working channel  50   a  of shaft  50 . 
     As shown in  FIG.  1   , system  5  may be a means by which tube  100  and a medical device  10  may be delivered within the body of a subject. Tube  100  is not particularly limited. For example, tube  100  may have a single lumen (not shown) configured to be connected to a vacuum source (not shown) at its proximal end. The distal end of tube  100  is coupled to medical device  10 . Thus, the lumen of tube  100  may establish communication between a vacuum source and medical device  10 . This communication may be established after medical device  10  and tube  100  are delivered within the body of a subject, and removed from medical system  5 . Alternatively, this communication may be established while medical device  10  and tube  100  remain within medical system  5 . In other embodiments, tube  100  remains in the body of the subject, exiting the subject through a nasogastric tube. The method of placement and delivery is not limited. The medical device  10  then may administer negative pressure to a surrounding wound, thereby assisting device  10  in absorbing and suctioning any fluids from the wound. Furthermore, the application of negative pressure to a wound, via device  10 , may be therapeutic and expedite the healing of the wound. The vacuum source is not particularly limited, and may be any suitable source. 
     Referring to  FIGS.  2 A-B , an embodiment of medical device  10  of  FIG.  1    is further described. Medical device  10  may be a device used for endoluminal wound treatment, e.g., an EVAC device. Thus, medical device  10  may be in a configuration in which it is deliverable to a wound, e.g., a leak, cyst, a perforation, etc., via tube  100 . Device  10 , once delivered to the wound, may subsequently transition into a configuration in which it is deployed, and ready for treatment. 
     Medical device  10  includes a compressed porous body/sponge  12 , as described above, and a capsule covering  14 . Sponge  12  may be compressed to an extent so that it, along with capsule  14 , may fit within a working channel of any suitable scope and may be deliverable through a natural body lumen of a subject. The manner by which compressed sponge  12  is fit within capsule  14  is not particularly limited, and may be by any suitable manner. For example, sponge  12 , after compression, may be inserted into an already formed capsule covering  14 . In another example, sponge  12 , while compressed, may be coated with a capsule coating which forms capsule covering  14 . 
     Capsule  14  encapsulates compressed sponge  12  in its entirety, but is not limited thereto. In other exemplary embodiments, capsule  14  may cover sponge  12  partially. Capsule  14  may be of any suitable material that may withstand the expandable nature of, and outward forces generated by, compressed sponge  12 . In addition, capsule  14  may be of any suitable material configured to dissolve when exposed to fluids of any sort, including fluids having a predetermined pH. Thus, for example, capsule  14  may instantly or gradually dissolve when placed into, and coming into contact with fluids within the body of a subject, via the gastrointestinal tract. Alternatively, capsule  14  may dissolve when capsule  14  is exposed to fluid, e.g., saline, from an external source, via tube  100  or another tool. Suitable materials for capsule  14  include gelatin or other collagen derivatives, hypromellose (HPMC) or other cellulose derivatives, starch, and absorbable polysaccharides. In other exemplary embodiments, capsule  14  may be formed of a suture wrapped to compress the sponge  12 , or a mesh material, as described below. The thickness of the layer of capsule  14  is not particularly limited, so long as it allows for both the delivery of device  10  and the deployment of sponge  12 . Suitable thicknesses of capsule  14  may be dependent on the material of capsule  14 , and may include thicknesses greater than, for example,  100  microns. Thus, device  10  may include a delivery configuration, in which compressed sponge  12  is contained within capsule  14 , and a deployed configuration, in which capsule  14  is removed or dissolved and sponge  12  is expanded. 
     Medical device  10  also includes an opening  16 , through which an end of tube  100  may be inserted and thus connected to device  10 . Opening  16  extends through both capsule  14  and sponge  12 . Opening  16  may be on a proximal end/surface of device  10 . Opening  16  may be of any suitable diameter that allows for a secure fit over tube  100 . Additionally, opening  16  may be of any suitable depth that also allows for a secure fit over tube  100 , while also allowing for a sufficient amount of negative pressure to be distributed throughout device  10  when deployed in a wound. The sponge  12  may be connected to the tube  100  such that the interconnected channels, open cells, or continuous passages in the sponge  12  allow for fluid and materials to be suctioned into the tube  100 . 
     The manner and order in which medical device  10  is formed is not particularly limited. In some exemplary embodiments, opening  16  may be formed in sponge  12 , prior to compression of sponge  12 , and tube  100  may be inserted into opening  16 . Sponge  12  may then be compressed, for example by dehydrating sponge  12  and/or applying suction to sponge  12 , to close pores and channels within sponge  12 . During or after compression, capsule  14  may be fitted or formed over compressed sponge  12 , while accommodating for tube  100 . Capsule may be placed over sponge  12  via any suitable method, including coating, e.g., spray coating, dip coating, etc., or wrapping. 
     Referring to  FIGS.  1  and  2 A -B, an example of how medical device  10  may be delivered and used is further discussed below. A user may deliver device  10 , while in its delivery configuration, into the body of a subject, e.g., via a natural orifice (such as a mouth or anus). Device  10  may traverse through a tortuous natural body lumen of the subject, such as an esophagus, stomach, colon, etc. Device  10 , via tube  100 , may be delivered in any suitable way, for example, through working channel  50   a  of endoscope  5 , by inserting device  10 , including tube  100 , into port  54  of endoscope  5 . Alternatively, device  10  and tube  100  may be placed in a patient via a nasogastric tube. A user may direct/position device  10  within the wound, e.g., perforation, leak, cyst, cavity, for endoluminal wound treatment. A user may then transition device  10  to a deployed configuration by exposing capsule  14  to fluid within the body or from an external source, thereby removing capsule coating  14 . Compressed sponge  12  may subsequently expand within the wound, for example, until it applies suitable pressure against the walls of the wound. A user may then remove endoscope  5  from the delivered tube  100  and device  10 . Subsequently thereafter, a user may couple the proximal end of tube  100  to a vacuum source, and then turn on the vacuum source at any suitable time to supply suction or negative pressure to sponge  12 , via a lumen of tube  100 . Alternatively, a user may start supply of suction while device  10  is in a delivery configuration. 
     Medical device  10 ′, as shown in  FIG.  3   , is similar to device  10  in many respects. Like reference numerals refer to like parts. Differences between device  10  and device  10 ′ will be described below. Instead of a capsule coating, device  10 ′ includes a netting  24  wrapped around sponge  12 . Like capsule  14  of device  10 , netting  24  may be implemented to compress sponge  12  and to contain sponge  12 , via the mechanical pressure of netting  24 , while holding its shape. Netting  24  may compress and contain sponge  12  so that device  10 ′ may be deliverable through a working channel of a scope, e.g., endoscope  5 . Netting  24  may be of any suitable materials and is not particularly limited. Suitable materials for netting  24  include any suitable polymer, such as nylon or polypropylene. Furthermore, the manner in which netting  24  is netted is not particularly limited as well. Netting  24  may be applied in a spiral, criss-cross, irregular, or other pattern, via any suitable method. 
     Device  10 ′ further includes a control thread or wire  26  that is coupled to netting  24 . Wire  26  is coupled to a proximal portion of netting  24  in  FIG.  3   , but is not limited thereto. Control wire  26  may be a strand(s) of netting  24 , or a separate thread or wire component. Wire  26  may be configured to shear or remove netting  24  by a suitable force applied to wire  26 , e.g., a pulling force. Wire  26  may extend through a lumen of tube  100  (not shown) or outside a lumen of tube  100  as shown, and a proximal end of wire  26  may be connected to a controller or mechanism (not shown) configured to exert the necessary force on wire  26  to remove netting  24 . Alternatively, the proximal end of wire  26  may be free and pulled proximally by the user. Thus, wire  26  may assist in transitioning device  10 ′ from a delivery configuration to a deployed configuration. In embodiments, the netting may be formed of a material that will degrade or dissolve upon contact with fluid. 
     However, device  10 ′ is not limited to including a control wire  26 . In some other exemplary embodiments, device  10 ′ may be without wire  26 , and may include other suitable mechanisms configured to remove netting  24  and deploy sponge  12 . For example, netting  24  may include a breaking point, e.g., a stress riser, so that netting  24  may fracture when sponge  12  is advanced and pressed against said breaking point of netting  24 . In some exemplary embodiments, such a breaking point may be found on the distal end of netting  24 . Alternatively, netting  24  may be severed from sponge  12  via an endoscopic scissor or other tool. 
     Like device  10 , the manner and order in which medical device  10 ′ is formed is not particularly limited. In some exemplary embodiments, opening  16  may be formed in sponge  12 , prior to compression of sponge  12 , and tube  100  may be inserted into opening  16 . Sponge  12  may then be compressed, for example by application of suction. After compression, netting  24  may be fitted over compressed sponge  12 , while accommodating for tube  100 . In other exemplary embodiments, netting  24  may be fitted over sponge  12  prior to compression, and netting  24  may be tightened to mechanically compress and contain sponge  12 . 
     Device  10 ′ may be used in a similar manner as device  10 , except a user may transition device  10 ′ to a deployed configuration by removing netting  24 , via wire  26  or any other suitable manner/mechanism. 
     Medical device  10 ″, as shown in  FIGS.  4 A-B , is also similar to device  10  in many respects. Like reference numerals refer to like parts. Differences between device  10  and device  10 ″ will be described below. Instead of a capsule coating, device  10 ″ includes a membrane  34 . Membrane  34  is not particularly limited, and may be of any suitable impermeable material, e.g., flexible plastic, latex, etc. Membrane  34  may be flexible and/or elastic. The thickness of membrane  34  is not particularly limited as well. Membrane  34  encapsulates sponge  12  by being fixed to a distal portion of the outside of a delivery tube/catheter  102 . Membrane  34  may be fixed around a complete circumference of the distal portion of catheter  102 . Catheter  102  may be flexible and sized to fit within working channel  50   a  of scope  50 . Catheter  102  includes an inner channel  102   a  that receives tube  100 . Tube  100  moves axially within channel  102   a.  As shown in  FIG.  4 A , membrane  34  may form a cavity  36  containing sponge  12 , in a non-compressed state. 
     Catheter  102  may be connected to a vacuum source so that channel  102   a  is in fluid communication with cavity  36  formed by membrane  34 . To transition device  10 ″ from a default, expanded configuration to the compressed, delivery configuration, the vacuum source may transmit suction distally, through channel  102   a  and down to cavity  36  of device  10 ″. As a result of the suction and impermeable membrane  34  being fixed to catheter  102 , membrane  34  collapses onto sponge  12 , thereby compressing sponge  12  uniformly, as shown in  FIG.  4 B . Compressed sponge  12  may then be retracted into channel  102   a  to maintain its compressed state, by pulling tube  100  proximally. Membrane  34  may subsequently be removed or may be maintained. Device  10 ″ may be placed into such a delivery configuration during the manufacture of the device. This may enable sponge  12  to be loaded into a delivery system with reduced tensile forces, thus potentially preventing damage. Alternatively, device  10 ″ may be maintained in the state as illustrated in  FIG.  4 B . However, maintaining device  10 ″ in the delivery configuration shown in  FIG.  4 B  may require that suction, through working channel  50   a,  be continuously transmitted, if sponge  12  does not tolerate compression for an extended duration. Alternatively, membrane  34  may be of such a material that maintains its compressed configuration of  FIG.  4 B  in the absence of suction. 
     The deployed configuration of device  10 ″ is not particularly limited. For example, when compressed sponge  12  is retracted within channel  102   a,  as described above, sponge  12  may be extended distally out of catheter  102  to be deployed within the targeted wound. In instances in which membrane  34  is maintained, the distal end of membrane  34  may be slit (e.g. perforated or having a weakened region) so that sponge  12  may be deployed through the slit. In other examples, when device  10 ″ is maintained in the configuration as shown in  FIG.  4 B , membrane  34  may be removed when device  10 ″ is delivered to the targeted wound. The manner by which membrane  34  may be removed is not particularly limited, for example an additional tool (such as a grasper) may be used. In some exemplary embodiments, membrane  34  may be of a biodegradable material, so that membrane  34  may dissolve as it reaches the targeted wound. In other exemplary embodiments, membrane  34  may include a means by which it may break or rupture, e.g., perforations or thinned portions, so that membrane  34  may break or rupture as sponge  12  is driven forward (distally). Compressed sponge  12 , once deployed, may naturally expand to its pre-compressed state until it reaches its fully expanded state and/or applies pressure against the walls of the wound area. In another embodiment, catheter  102  may be omitted from the embodiment of  FIGS.  4 A- 4 B , and membrane  34  may be fixed around a complete circumference of a distal portion of tube  100 . Suction applied through tube  100  will collapse membrane  34  and compress sponge  12 . 
     Device  10 ″ may be used in a similar manner as device  10 , except a user may transition device  10 ″ to a deployed configuration by removing or breaking membrane  34 , via the above described manners or mechanisms. 
     It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the disclosure. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.