Medical systems, devices, and related methods for wound treatment

Abstract

A medical system comprising a handle, a shaft extending distally from the handle, the shaft including one or more channels extending between the handle and the distal end of the shaft, and a cap assembly coupled to the distal end of the shaft. At least one of the one or more channels includes a working channel. The cap assembly includes an opening at the distal end of the shaft aligned with at least one of the one or more channels. The medical system includes a chamber extending distally from the opening and a porous body movably disposed within the chamber. The chamber is aligned with the working channel, and the porous body is configured to transition from a compressed configuration when placed within the chamber to an expanded configuration when extending outward from the chamber.

Description

Technical Field

[0001] Various aspects of the present disclosure generally relate to medical systems, devices, and related methods that can be used to treat a subject. In particular, aspects of the present disclosure relate to medical systems, devices, and methods for treating wounds, such as endoscopic vacuum therapy that includes applying negative air pressure to tissue for wound treatment.

Background Art

[0002] Endoscopic and open surgical procedures of the gastrointestinal (GI) tract include, for example, colectomy, obesity surgery, esophagectomy, gastric bypass surgery, sleeve gastrectomy, and the like. These surgeries can result in perforation, postoperative leakage, or other wounds of the GI tract. The morbidity and mortality rates of such wounds are quite high, and treatment options are limited. Options include surgical reoperation and endoscopic placement of a stent or one or more clips. Surgery is invasive and is associated with high morbidity and mortality. Although endoscopic stent placement is less invasive, the placed stent may move from the intended position and / or worsen infection by enclosing the infection at the treatment site and / or inhibit drainage. The systems, devices, and methods of the present disclosure can improve one or more of the above-mentioned deficiencies or address other aspects of the art.

Summary of the Invention

[0003] Each aspect disclosed herein may include one or more of the features described in relation to any of the other disclosed aspects. Aspects of the present disclosure relate, among other things, to systems, devices, and methods for treating a subject. Aspects of the present disclosure relate to medical systems, devices, and methods for treating wounds, such as endoscopic vacuum therapy that includes applying negative air pressure to tissue for wound treatment.

[0004] For example, the medical system includes a handle, a shaft extending distally from the handle, the shaft including one or more channels extending between the handle and the distal end of the shaft, at least one of the one or more channels including a working channel, a cap assembly coupled to the distal end of the shaft including an opening aligned with at least one of the one or more channels at the distal end of the shaft, and a chamber extending distally from the opening, the chamber aligned with the working channel, and a porous body movably disposed within the chamber, the porous body configured to transition from a compressed configuration when disposed within the chamber to an expanded configuration when extended outward from the chamber.

[0005] Any medical system described herein may include any of the following features: a tube movably coupled to the cap assembly, the tube being configured to move between a first position and a second position relative to the cap assembly, thereby transitioning the porous body between a compression configuration and an expansion configuration; in the first position, the distal end of the tube is positioned outside the chamber, thereby maintaining the porous body in the compression configuration within the chamber; in the second position, the distal end of the tube is positioned inside the chamber, thereby extending the porous body outside the chamber and transitioning to the expansion configuration. The tube is a vacuum tube, the proximal portion of which is coupled to a negative pressure source, and the distal portion of which is coupled to the porous body. The vacuum tube is configured to apply negative pressure provided by the negative pressure source to the porous body. The chamber is configured to receive the tube when it is in the second position, and at least a portion of the chamber is deformable to facilitate the release of the tube from the chamber. The tube is slidably housed within the working channel of the shaft. The cap assembly is removably attached to the outer surface of the distal end of the shaft. The cap assembly is selectively rotatable around the outer surface of the distal end of the shaft so that the chamber can be repositioned relative to one or more channels while maintaining alignment with the working channels. The porous material is a sponge, gauze, film, or membrane. The chamber is at least partially transparent so that the porous material placed inside the chamber is visible through the chamber. The chamber includes a window through which the porous material placed inside the chamber is visible to an imaging device. The chamber includes an expansion wall that defines the cross-sectional dimensions of the chamber to minimize compression of the porous material contained within the chamber. The expansion wall is sized and shaped so that the chamber has a teardrop shape.The cap assembly is securely attached to the shaft via a frictional engagement between the body of the cap assembly and the distal end of the shaft.

[0006] In another example, a medical device includes a cap assembly configured to be mounted around the shaft of an endoscope, thereby making the working channel of the endoscope accessible through an opening in the cap assembly at the distal end of the shaft, the cap assembly including a chamber extending distally from the distal end and aligned with the working channel of the shaft, and a porous body housed within the chamber, the chamber configured to compress the porous body relative to the shaft, and the porous body being movable relative to the cap assembly from a first position and compressed configuration within the chamber to a second position and expanded configuration outside the chamber. Any medical device described herein may include any of the following features: a tube positioned within the working channel, the first end of the tube coupled to a negative pressure source and the second end coupled to the porous body, the negative pressure source communicating with the porous body through the tube; the tube being movable relative to the working channel to extend the porous body out of the chamber, and the tube being configured to generate a vacuum through the porous body in response to the operation of the negative pressure source; the chamber being configured to receive the tube as the tube extends the porous body out of the chamber, and at least a portion of the chamber being deformable to allow the tube to be easily released from the chamber; the chamber including an expansion wall defining the cross-sectional dimensions of the chamber to minimize compression of the porous body contained within the chamber, the expansion wall being sized and shaped such that the chamber has a teardrop configuration.

[0007] In another example, a method of treating a wound cavity using a medical device includes positioning the shaft of the medical device in the wound cavity, with a cap assembly mounted on the shaft so as to be positioned adjacent to the wound cavity, and the chamber of the cap assembly aligned with the working channel of the shaft; expanding the porous body as it moves out of the chamber into the wound cavity by extending a porous body out of the chamber in response to moving a tube relative to the chamber, the tube being coupled to the porous body and in communication with a negative pressure source; and applying negative pressure to the wound cavity through the porous body in response to activating the negative pressure source.

[0008] It will be understood that both the general description above and the detailed description below are for illustrative and explanatory purposes only and do not limit the invention as described in the claims. The terms “includes,” “contains,” or other variations thereof as used herein are intended to be non-exclusive. That is, a process, method, article, or apparatus that includes a list of elements may include other elements that are not expressly listed or that are specific to such process, method, article, or apparatus, rather than including only those elements. The term “diameter” may refer to the width if the element is not circular. The term “distal” refers to the direction away from the user / towards the treatment site, and the term “proximal” refers to the direction towards the user. The terms “downward,” “upward,” “bottom,” “upper,” “bottom,” and “top” may refer to the direction of the element relative to the drawing as shown throughout the drawing. The term “exemplary” is used to mean “example,” not “ideal.” The term “approximately,” or similar terms (e.g., “substantially”) includes values ​​of + / - 10% of the stated value. [Brief explanation of the drawing]

[0009] The accompanying drawings incorporated herein and forming part thereof illustrate aspects of this disclosure and, together with the specification, help to illustrate the principles of this disclosure. [Figure 1] The following are perspective views of exemplary medical systems according to several embodiments. [Figure 2] Figure 1 shows perspective views of exemplary medical devices coupled to the medical system according to several embodiments. [Figure 3] Figure 2 shows perspective views of the medical device according to several embodiments. [Figure 4] Figure 2 shows cross-sectional views of the medical device according to several embodiments. [Figure 5A] Figure 2 shows a perspective view of the medical device in a first position according to several embodiments. [Figure 5B] Figure 2 shows a perspective view of the medical device in a second position according to several embodiments. [Figure 5C] Figure 2 shows a perspective view of the medical device in a third position according to several embodiments. [Figure 5D] Figure 2 shows a perspective view of the medical device in a fourth position according to several embodiments. [Figure 6] A perspective view of another exemplary medical device coupled to the medical system of Figure 1, according to several embodiments, is shown. [Figure 7] The images show front views of alternative configurations of the medical device shown in Figure 6, coupled to the medical system shown in Figure 1, according to several embodiments. [Modes for carrying out the invention]

[0010] Detailed explanation Endoluminal vacuum therapy (EVAC) is a modified form of negative pressure wound therapy (i.e., vacuum therapy or wound vac) that can be used as an external treatment for chronic, non-healing wounds. This therapy involves inserting a vacuum sealing material (e.g., a sponge) into the wound and applying negative pressure to the sponge to promote drainage. In a typical EVAC procedure, negative pressure is applied to the wound site from the inside within the GI tube, for example, through a nasogastric tube with a sponge at the end. The sponge is positioned in the perforation, leakage, or other wound using an endoscope, and then negative pressure is applied to promote drainage from the wound.

[0011] Embodiments of the present disclosure include devices, systems, and methods, particularly for EVAC procedures. In some embodiments, EVAC may involve the endoscopic placement of a porous material (e.g., sponge or other similar material) into a wound site such as a perforation, cyst, leakage, or anastomosis. The porous material may be placed in the wound via a catheter, scope (e.g., endoscope, bronchoscope, colonoscope, etc.), tube, or sheath that can be inserted into the GI tube through a natural opening. The opening may be, for example, the nose, mouth, or anus, and the distal end of the catheter, scope, tube, or sheath (and therefore the porous material) can be placed in any part of the GI tube, including the esophagus, stomach, duodenum, large intestine, and small intestine.

[0012] Figure 1 shows an exemplary medical system 100. The medical system 100 may include an insertion device such as an endoscope that can be inserted into a patient's esophagus. The medical system 100 may include a handle 112 and a shaft 110 extending distally from the handle 112. The shaft 110 may include one or more channels that extend through from a proximal portion located adjacent to the handle 112 to a distal portion 118 terminating at a distal tip 119. In some embodiments, the medical system 100 may include an umbilicus (not shown) to which the port 108 of the endoscope can be connected to, for example, a power source such as air, water, suction, or electricity, or to image processing and / or image display equipment. In some embodiments, the medical system 100 may include an image sensor and / or illumination element at the distal tip 119 or the like to help precisely position the shaft 110 adjacent to a target treatment site (e.g., a wound cavity) during EVAC procedures. Using one or more channels of the shaft 110, a user of the medical system 100 can deploy or otherwise deliver a medical device or instrument, such as a medical instrument 122, received via the port 116 of the handle 112, to a target therapeutic site.

[0013] In some embodiments, the handle 112 may include one or more actuators along the proximal end of the handle 112 (e.g., adjacent to the port 108) to control, for example, the movement of the shaft 110, particularly the distal portion 118, the driving of one or more image sensors and illumination elements, and the deflection, position, or orientation of the distal tip 119. Figure 1 shows the distal tip 119 of a medical system 100 (e.g., an endoscope) as "forward-facing," in which case it should be noted that features of the distal tip 119, such as one or more channels of the shaft 110, may be oriented distally (i.e., forward of the most distal surface of the distal tip 119). It should be understood that this disclosure also encompasses other configurations of the distal tip 119. These include a "lateral" distal tip 119, in which one or more channels of the shaft 110 are located radially outward of the distal tip 119, and the distal tip 119 is radially outward, substantially perpendicular to the longitudinal axis of the distal portion 118.

[0014] Referring further to Figure 1, the insertion device or medical system 100 is described above as an endoscope, but the disclosure is not limited thereto. While the disclosure may refer to endoscopes in various ways, it will be understood that, unless otherwise specified, duodenoscopes, endoscopes, gastroscopy, endoscopic ultrasound ("EUS") scopes, colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, cytoscopes, suction scopes, sheaths, catheters, or other appropriate delivery or insertion devices may be used in combination with the systems, devices, elements, assemblies, methods, etc. described herein.

[0015] Referring to Figure 2, the medical system 100 may include a medical device coupled to the shaft 110. In this example, the medical device may include a cap assembly 200 that can be detachably coupled to the shaft 110 along the distal portion 118. In other words, the cap assembly 200 can be detachably attached to the distal portion 118. The cap assembly 200 may be configured to be attached to the outer surface of the shaft 110 adjacent to the distal tip 119 by various suitable means. As an example, the cap assembly 200 can be securely attached to the shaft 110 by forming a friction engagement with the outer surface of the shaft 110. In embodiments in which the shaft 110 includes an articulation, it should be understood that the cap assembly 200 may be coupled to the shaft 110 distal to the articulation. For example, the entire cap assembly 200 may be distal to the most distal end of the articulation.

[0016] The cap assembly 200 may include a body 202 having a cylindrical structure of a size, shape, and / or other configuration for receiving the shaft 110. In other words, the body 202 may define a channel 203 that passes through the cap assembly 200, and the body 202 is configured to receive the shaft 110 through the channel 203 so that when the shaft 110 is received, the body 202 can extend around the outer surface of the shaft 110, particularly from the distal portion 118. The cap assembly 200 may be configured so that the inner surface of the body 202 defining the channel 203 frictionally engages with the distal portion 118 of the shaft 110, thereby restricting the movement (e.g., axial movement) of the distal tip 119 housed therein. Thus, the body 202 is configured to engage and / or grip the outside of the distal portion 118 when the distal portion 118 is received by the body 202, thereby coupling the cap assembly 200 to the shaft 110. The main body 202 can define an opening 208 for receiving the distal tip 119 of the shaft 110 when the distal portion 118 is received through the channel 203 of the main body 202.

[0017] The cap assembly 200 may further include a chamber 210 extending distally from the body 202. The chamber 210 may have a longitudinal length defined between a first (proximal) end 211 formed integrally with the body 202 and a second (distal) end 212 located opposite the first end 211. In this example, the chamber 210 may have a substantially rigid structure. For example, the chamber 210 may be made of a thermoplastic polymer, a semi-rigid plastic, and the like. In other examples, the chamber 210 may include a pocket, bag, or other suitable component of a relatively flexible structure.

[0018] Referring further to FIG. 2, the chamber 210 may define a lumen 215 sized, shaped, and / or otherwise configured to receive one or more vacuum therapy devices. For example, the vacuum therapy device may include a device configured to act on a target treatment site (e.g., tissue) within a subject (e.g., a patient). The vacuum therapy device may be at least partially absorbent and may include, without limitation, a vacuum therapy sponge, gauze, film, membrane, etc. In this example, the vacuum therapy device may include a porous body 220. In some embodiments, the porous body 220 may include any suitable biocompatible material that can absorb liquid and / or allow liquid to pass therethrough under negative pressure. This material may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The material of the porous body 220 may be a continuous foam or may include a continuous foam. Suitable materials include polyurethane, polymers having ester and / or ether functional groups, composite materials, and other medical grade materials.

[0019] The porous body 220 may have at least a partially flexible longitudinal length and a transverse diameter and / or width. Thus, the porous body 220 is at least partially compressible, and the chamber 210 may be configured to compress the porous body 220 into a compressed configuration when the porous body 220 is received therein. The chamber 210 may further be configured to secure the porous body 220 therein with no force applied to the porous body 220 for deployment from the chamber 210.

[0020] It should be understood that when the porous body 220 is in the compressed configuration, the diameter of the porous body 220 may correspond to the diameter of the lumen 215 of the chamber 210. For example, the diameter of the lumen 215 may be less than about 20 millimeters to facilitate navigation of the cap assembly 200 through a tortuous path such as the esophagus of a subject (e.g., a patient). As further described herein, the cap assembly 200 may be configured to transition the porous body 220 from the compressed configuration to the expanded configuration when the porous body 220 is deployed distally from the lumen 215 of the chamber 210 (see FIGS. 5B - 5D).

[0021] The chamber 210 may include a distal opening 213 at the second end 212 that is sized and / or shaped to facilitate deployment of the porous body 220 out of the chamber 210. The chamber 210 may further include a window 214 extending along the longitudinal length of the chamber 210, particularly between the first end 211 and the second end 212. The window 214 may be, for example, a slot. In a state where the porous body 220 is housed within the chamber 210, the cap assembly 200 is operable to visually access the porous body 220 through the window 214 from outside the chamber 210. In other words, the cap assembly 200 is operable to provide visual feedback of the position of the porous body 220 during a procedure of delivering the porous body 220 to a target treatment site (e.g., a wound cavity) through the window 214 via the medical system 100 and the cap assembly 200. For example, the chamber 210 may be disposed relative to the distal tip 119 such that the imaging assembly 102 of the medical system 100 can visualize the porous body 220 through the window 214. In other examples, the window 214 may be completely omitted. In some embodiments, the chamber 210 may be formed of an opaque material. In other embodiments, at least a portion of the chamber 210 may be transparent and / or translucent to further facilitate visual inspection of the porous body 220 from within the chamber 210. In this case, the porous body 220 may be visible through the chamber 210.

[0022] Referring further to Figure 2, the cap assembly 200 may include a fluid component that is coupled to and communicates with the porous body 220. For example, the fluid component of the cap assembly 200 may include a tubular member 230 (e.g., a vacuum tube) coupled to the proximal end of the porous body 220. The tubular member 230 may be formed from a polymer or other suitable biocompatible material. In some embodiments, the tubular member 230 may include a shape memory film, such as a nitinol film, or may be formed from a shape memory material and / or a thermosetting material (e.g., nitinol). As described herein, the tubular member 230 may be configured to move the porous body 220 in response to the movement of the tubular member 230 relative to the body 202.

[0023] As best shown in Figure 3, the tube member 230 may be located inside the shaft 110, and in particular, the tube member 230 may be slidably housed within the working channel 120 of the shaft 110. The tube member 230 may exit the working channel 120 at its distal end 119 and extend into the chamber 210 through the opening 208. If the porous body 220 is located within the chamber 210, the proximal end of the porous body 220 may be located adjacent to the body 202 and the first end 211, and the end (distal end) of the tube member 230 may also be located within the body 202 and within the working channel 120. The tube member 230 may be configured to extend at least the distal portion of the porous body 220 distally outward from the chamber 210 by moving the porous body 220 distally (e.g., parallel translation) through the distal opening 213 as the tube member 230 moves distally relative to the main body 202 (see Figures 4B-4D). In this case, the tube member 230 can extend outward from the working channel 120 into the chamber 210 and distally relative to the first end 211, as shown in Figure 4 (showing the porous body 220 partially unfolded from the chamber 210 and partially held within the chamber 210).

[0024] Although not shown, it should be understood that the tube member 230 may include one or more openings and / or ports at its distal end that communicate with the porous body 220. As described herein, the tube member 230 may be coupled such that its proximal end (not shown), opposite to the distal end of the tube member 230, communicates with a negative pressure (vacuum) source. Thus, the porous body 220 can communicate with the negative pressure source via the tube member 230, particularly via one or more openings and / or ports at the distal end of the tube member 230.

[0025] Referring further to Figures 3-4, the body 202 may be sized, shaped, and / or otherwise configured such that when the cap assembly 200 is coupled to the distal portion 118, the chamber 210 is positioned in axial alignment with one or more channels of the shaft 110, particularly the working channel 120. In other words, the chamber 210 may be positioned relative to the body 202 such that when the body 202 is coupled to the distal portion 118, the chamber 210 is suspended in axial alignment with the openings of at least one or more channels of the shaft 110, including the working channel 120. In this case, the openings of the working channel 120 (and one or more of the other channels of the shaft 110) may overlap with the chamber 210 so that a tubular member 230 extending through the working channel 120 can be accommodated within the chamber 210. At least one of the other channels of the shaft 110 is positioned alongside the opening 208 and outside the chamber 210 (e.g., radially outward), so that one or more medical instruments or devices (e.g., air, water, light, etc.) can extend from the shaft 110 through these channels without interference from the chamber 210 and access the target therapeutic site through the opening 208.

[0026] Referring particularly to Figure 4, the cap assembly 200 may include a retaining mechanism 216 along the chamber 210 for holding the porous body 220 within the chamber 210 when no distal force is applied to unfold the porous body 220 from the chamber 210. In some embodiments, the retaining mechanism 216 may include various suitable devices such as projections, tabs, abutments, and clips. In this example, the retaining mechanism 216 may include a beveled edge positioned around the distal opening 213 of the second end 212. The beveled edge of the retaining mechanism 216 may be sized, shaped, and / or otherwise configured such that it extends laterally inward from the second end 212 and at least partially into the distal opening 213.

[0027] The retaining mechanism 216 is configured to abut the most distal end of the porous body 220 when the porous body 220 is positioned within the lumen 215 of the chamber 210, thereby preventing unintended mispositioning / unfolding of the porous body 220 from the chamber 210. The retaining mechanism 216 may be configured to allow the porous body 220 to unfold distally from the chamber 210 in response to a distal force applied to the porous body 220 from a tube member 230 or the like. It should be understood that if the distal force exceeds a predetermined threshold, the porous body 220 may be propelled beyond the retaining mechanism 216 and out of the chamber 210. Once out of the chamber 210, a portion of the porous body 220 gradually transitions to an expanded configuration, as shown in Figure 4.

[0028] In exemplary use, as shown in Figures 5A–5D, the medical system 100 may be used to perform endoscopic vacuum therapy to treat a targeted treatment site by deploying a vacuum therapy device (e.g., a porous body 220) via a cap assembly 200. For example, the medical system 100 may be operated so that the shaft 110 moves through the object (e.g., a patient) through the GI canal of the object (e.g., a patient) and reaches the targeted treatment site (e.g., a wound cavity). The wound cavity may be in the form of anastomotic leakage, perforation, or other damage within the GI canal. The distal tip 119 may be positioned adjacent to the wound cavity with the cap assembly 200 attached. The position of the porous body 220 can be determined based on visual feedback generated by the cap assembly 200 by visualizing the position of the porous body 220 through the window 214 using an imaging assembly 102 while the porous body 220 remains positioned within the chamber 210.

[0029] Referring particularly to Figure 5A, the distal tip 119 may be positioned to orient the chamber 210 toward the wound cavity. In this case, the porous body 220 can access the wound cavity in addition to any medical devices or instruments located in one or more channels of the shaft 110 accessible from the cap assembly 200 through the opening 208. In this case, the tubing member 230 is in a first position relative to the working channel 120, and the porous body 220 may be positioned entirely within the chamber 210. It should be understood that the first position of the tubing member 230 is the most proximal position in which the tubing member 230 is positioned within the working channel 120 and outside (i.e., proximal) of the chamber 210. In the first position, the distal end of the tubing member 230 may be positioned outside the chamber 210. In other embodiments, the porous body 220 may have a longitudinal length shorter than the longitudinal length of the chamber 210. In this example, when in the first position, the distal end of the tube member 230 may be positioned outside (proximal side) of the chamber 210 with the distal end of the porous body 220 positioned proximal to the distal end 212 of the chamber 210, or it may be positioned inside the chamber 210 with the distal end of the porous body 220 positioned flush with the distal end 212. As will be described later, the tube member 230 can start deploying the porous body 220 distally from the chamber 210 by moving from the first position to the second position.

[0030] As shown in Figure 5B, distal movement (e.g., translation) of the tube member 230 to a second position results in a corresponding movement of the porous body 220, thereby causing the distal portion of the porous body 220 to exit the chamber 210 through the distal opening 213. As it moves toward the second position, the distal portion of the tube member 230 can extend into the chamber 210 such that at least a portion of the tube member 230 and at least a portion of the porous body 220 are simultaneously positioned within the chamber 210. As the porous body 220 extends distally from the chamber 210, the lateral / radial inward forces applied to the outside of the porous body 220 by the chamber 210 are gradually removed, allowing the porous body 220 to expand. In other words, the tube member 230 may be configured to transition the porous body 220 from a compressed configuration (Figure 4A) to an expanded configuration as the porous body 220 is pushed distally out of the chamber 210 when the tube member 230 moves from a first position to a second position.

[0031] Referring here to Figure 5C, by continuously moving the tubular member 230 distally to a third position, the porous body 220 can be completely removed from the chamber 210, thereby transitioning the entire porous body 220 into an expanded configuration. It should be understood that when transitioning to the expanded configuration, the porous body 220 can expand laterally / radially, axially, and / or in various other appropriate manners. In some embodiments, the position of the porous body 220 can be controlled via the medical system 100, particularly by moving the shaft 110. In further embodiments, the position of the porous body 220 can be controlled by the movement of the tubular member 230 relative to the shaft 110, the body 202, and the chamber 210.

[0032] As briefly explained above, the tube member 230 can be connected to the porous body 220 so as to communicate with a negative pressure source at its proximal end (not shown) opposite to the distal end of the tube member 230 connected to the porous body 220. Therefore, the porous body 220 can communicate with the negative pressure source via the tube member 230. As a result, in response to the operation of the negative pressure source, negative pressure is generated in the porous body 220 via the tube member 230, and an attractive force is generated in the environment surrounding the porous body 220, particularly in the wound cavity.

[0033] Referring to Figure 5D, the porous body 220 can be positioned in the wound cavity by moving the tube member 230 to a fourth position by extending the distal end of the tube member 230 further distally from the working channel 120 and chamber 210. Once the porous body 220 is positioned in the wound cavity, negative pressure can be applied to the wound cavity through the porous body 220 by activating a negative pressure source coupled to communicate with the tube member 230. In some embodiments, with negative pressure applied through the tube member 230, fluid in the wound cavity may flow into the porous body 220 and through the tube member 230, for example, by capillary action. In this case, the porous body 220 may be configured to heal the wound cavity by drawing any substance (e.g., fluid) in the wound cavity, such as fluid from postoperative leakage or perforation, into the porous body 220 and through the tube member 230, for the purpose of preventing drainage and promoting wound healing.

[0034] In other words, the medical system 100 (to which the cap assembly 200 is attached) may be operable to facilitate the deployment of a porous body 220 (e.g., a vacuum-sealed sponge) into the wound cavity and to perform endoscopic vacuum therapy using the cap assembly 200 in order to implement negative pressure wound therapy. Thus, the cap assembly 200 (and the porous body 220 in particular) may help to maintain fluid drainage even as the size of the wound cavity shrinks throughout the healing process. In some embodiments, the tubular member 230 and the porous body 220 may also be used to deliver fluid (e.g., saline solution, antibiotic solution, etc.) into the wound cavity and assist in, for example, irrigating and / or otherwise treating the wound cavity.

[0035] In some embodiments, the tube member 230 and the porous body 220 may be detached from the body 202 and the chamber 210, for example, to remove the shaft 110 from the object while maintaining the porous body 220 in the wound cavity. In this example, the body 202 and / or the chamber 210 may be made of a fragile material and / or may be configured such that the tube member 230 is released from the chamber 210 by deforming at least partially when a predetermined force is applied. In other words, the tube member 230 can release the tube member 230 from the chamber 210 by applying a force exceeding a predetermined threshold to the body 202 and / or the chamber 210 (for example, on the inner surface of the body 202 and / or the chamber 210), thereby permanently or temporarily deforming the body 202 and / or the chamber 210. For example, the tube member 230 can be moved relatively downward until the main body 202 and / or chamber 210 deform along their respective lower surfaces, forming an opening that allows the tube member 230 to exit the main body 202 and chamber 210. In this case, the shaft 110 can be completely removed from the object, while the tube member 230 and porous body 220 can be controlled independently of the medical system 100.

[0036] It should be understood that the expanded configuration of the porous body 220 increases the surface area of ​​the porous body 220 within the wound cavity, thereby allowing the porous body 220 to recover (e.g., absorb) more fluid from the wound cavity than a typical cylindrical sponge. Furthermore, the increased surface area and improved absorbency allow the medical system 100 (e.g., one containing the porous body 220) to be maintained within the wound cavity for a longer period (i.e., reducing the frequency of removal and / or replacement).

[0037] As the size of the wound cavity shrinks during the healing process, a physician or other user can manually remove the porous body 220 from the wound cavity and replace it with a smaller porous body having smaller cross-sectional dimensions. In this case, the medical system 100 is equipped with another cap assembly 200 on the shaft 110, and the smaller porous body 220 is then placed in the wound cavity. In this example, the relatively small porous body 220 may be applied regularly and continuously to the wound cavity via the medical system 100 to promote wound healing. One or more of the porous body 220 or tubular members 230 may have antiseptic properties, for example, to help prevent or suppress infection and / or extend the period that the porous body 220 remains in the wound cavity.

[0038] Referring here to Figures 6-7, another exemplary cap assembly 300 is shown. Cap assembly 300 may be substantially similar to cap assembly 200, except for the differences explicitly described herein. Therefore, the same reference numerals are used to identify substantially similar components. Furthermore, cap assembly 300 may be configured and operable in a similar manner to cap assembly 200. For example, like cap assembly 200, cap assembly 300 may include a chamber 310 having a generally cylindrical configuration defining a lumen 315. The chamber 310 may include at least one expanded surface and / or expansion wall 312 (Figure 6) formed along a portion of the chamber 310 between a first (proximal) end 211 and a second (distal) end 212. The at least one expansion wall 312 may be angled, curved, and / or otherwise expanded radially outward relative to the generally cylindrical configuration of the rest of the chamber 310. In this example, the chamber 310, including the expansion wall 312, can form a teardrop shape. In other examples, it should be understood that the chamber 310 may be formed in a variety of suitable shapes, sizes, and / or configurations other than those shown and described herein, without departing from the scope of this disclosure.

[0039] Chamber 310 may be configured to accommodate a porous body 220 in a compressed configuration, similar to that shown and described above with respect to Chamber 210. At least one expansion wall 312 may be sized, shaped, and / or otherwise configured such that the degree of compression of the porous body 220 is minimized when it is placed inside Chamber 310. In other words, at least one expansion wall 312 may be configured to increase the cross-sectional dimensions of the lumen 315 of Chamber 310 relative to the lumen 215 of Chamber 210 (see Figure 2), thereby defining additional space within Chamber 310 for accommodating the porous body 220. Thus, when the porous body 220 is held inside Chamber 310, Chamber 310 can exert relatively small forces on the porous body 220, thus reducing the degree of compression of the porous body 220 within Chamber 210. In other words, the expansion wall 312 can define the cross-sectional dimensions of the chamber 310, which minimizes the compression of the porous material 220 against the chamber 210, while maintaining maximum functionality of the medical system 100 by not blocking one or more of the channels of the shaft 110 when the cap assembly 300 is coupled to the shaft 110.

[0040] In some embodiments, the expansion wall 312 may be selectively removable from the rest of the chamber 310 to deploy the porous body 220 from the cap assembly 300. For example, a pulley mechanism (not shown) may extend through at least one of the channels of the shaft 110, such as the working channel 120, and be fixed to the expansion wall 312. The pulley mechanism may be configured to peel the expansion wall 312 away from the chamber 310 in response to the operation of the pulley mechanism, thereby detaching the expansion wall 312 from the chamber 310. The pulley mechanism may include a pull wire and / or various other suitable devices. It should be understood that the cap assembly 300 may include a pulley mechanism instead of the tubular member 230 to prevent the porous body 220 from deploying from the chamber 310 in response to a pressing force applied to the porous body 220.

[0041] As best illustrated in Figure 7, at least one expansion wall 312 may be configured to release the porous body 220 from within the chamber 310 by minimizing the compressibility of the porous body 220 when placed within the chamber 310, allowing the porous body 220 to expand when the expansion wall 312 is removed. At least one expansion wall 312 may be positioned relative to the distal tip 119 such that the opening of the working channel 120 overlaps with the lumen of the chamber 310, but one or more openings of the remaining channels of the shaft 110 are not blocked, keeping such channels accessible and facilitating the use of other medical devices or instruments (e.g., fluids, air, lighting, etc.) through the shaft 110.

[0042] In some embodiments, the tube member 230 may further include a guide wire, an outer sheath, an inner sheath, a reinforcing mandrel, or other suitable devices. In one example, the tube member 230 is flexible and is housed within a rigid outer sheath (not shown) configured to increase the rigidity of the tube member 230 for the purpose of deploying the porous body 220 from the chamber 310. In other words, the guide wire, outer sheath, inner sheath, and / or reinforcing mandrel may be configured to prevent the tube member 230 from bending and / or breaking. For example, the tube member 230 and the porous body 220 may extend from the working channel 120 and the chamber 310, respectively, after which the shaft 110 may be withdrawn from the object. In this case, the guide wire, outer sheath, inner sheath, reinforcing mandrel, or other suitable devices may be configured to push the tube member 230 outward from the shaft 110 and to facilitate the control and / or operability of the tube member 230 within the object.

[0043] In one example, the outer sheath may include a removable portion configured to be peeled off and / or cut away from the rest of the outer sheath to facilitate the removal of the tube member 230. In another example, the tube member 230 may include a guide wire and / or reinforcing mandrel (not shown) placed inside the tube member 230 to increase the rigidity of the tube member 230 for the purpose of deploying the porous body 220 from the chamber 310. In this case, the guide wire and / or reinforcing mandrel may define a rail to facilitate the movement of the tube member 230 along the rail. In yet another example, both the tube member 230 and at least one of the guide wire and / or reinforcing mandrel may be placed inside the outer sheath. It should be understood that various other suitable configurations of the device may be coupled to and / or assembled together with the tube member 230.

[0044] In some embodiments, the cap assembly 300 may be configured to move (e.g., rotate) selectively relative to the distal end 119 of the shaft 110. In this case, the cap assembly 300 is movably coupled relative to the distal end 119, and the position and / or orientation of the body 202 can be adjusted relative to the distal end 119. By adjusting the cap assembly 300 relative to the shaft 110, the opening 208 and the chamber 310 can be repositioned to various suitable configurations relative to one or more channels of the shaft 110, particularly the opening of the channel at the distal end 119. It should be understood that in each such positional configuration relative to the distal end 119, the chamber 310 may remain in line with the working channel 120. Therefore, the chamber 310 (and the porous body 220 housed within it) is positioned adjacent to a specific channel of the shaft 110, more specifically, to a specific medical instrument and / or device located within the channel, while maintaining a alignment with the working channel 120, thereby facilitating access to the porous body 220 by the medical instrument and / or device. In this case, the relative position of the chamber 310 to the distal opening of the channel at the distal tip 119 improves the accessibility of the porous body 220 to one or more medical instruments and / or devices housed within the channel of the shaft 110, thereby improving control of the porous body 220 during treatment.

[0045] In some embodiments, the shaft 110 may include one or more marks (e.g., arrows) along the distal portion 118 and / or distal tip 119 to facilitate various appropriate placements of the cap assembly 300. The body 202 of the cap assembly 300 may similarly include corresponding marks for alignment with the marks on the shaft 110, thereby further facilitating the visual alignment of the complementary device.

[0046] The principles of this disclosure are described herein with reference to exemplary examples of specific uses, but it should be understood that this disclosure is not limited thereto. For example, this disclosure refers to EVAC as an exemplary procedure and to GI tubes as typical lumens of the systems and methods of this disclosure. However, the systems, devices and methods of this disclosure may be used for any appropriate medical procedure in any lumen or body cavity within the body, for example, to assist in the drainage of fluid from a wound at any location within the body. Those skilled in the art and with access to the teachings provided herein will recognize that all additional modifications, applications, and substitutions of equivalents are within the scope of the examples described herein. Therefore, the present invention should not be considered limited by the foregoing description.

Claims

1. It is a medical system, handle, A shaft extending distally from the handle, the shaft including one or more channels extending between the handle and the distal end of the shaft, and at least one of the one or more channels including a working channel, A cap assembly coupled to the distal end of the shaft, comprising an opening aligned in a line with at least one of the one or more channels at the distal end of the shaft, and a chamber extending distally from the opening, the chamber aligned in a line with the working channel, and A porous body movably disposed within the chamber, wherein the porous body is configured to transition from a compressed configuration when placed within the chamber to an expanded configuration when extended outward from the chamber. A healthcare system, including the medical system.

2. The medical system according to claim 1, further comprising a tube movably coupled to the cap assembly, wherein the tube is configured to move between a first position and a second position relative to the cap assembly, thereby causing the porous body to move between the compression configuration and the expansion configuration.

3. In the first position, the distal end of the tube is positioned outside the chamber, thereby maintaining the porous body in the compressed configuration within the chamber. In the second position, the distal end of the tube is positioned inside the chamber, so that the porous body extends outside the chamber and transitions to the extended configuration, the medical system according to claim 2.

4. The medical system according to claim 3, wherein the tube is a vacuum tube, the proximal portion of the vacuum tube is connected to a negative pressure source, and the distal portion of the vacuum tube is connected to the porous body.

5. The medical system according to claim 4, wherein the vacuum tube is configured to apply the negative pressure provided by the negative pressure source to the porous body.

6. The medical system according to any one of claims 2 to 5, wherein the chamber is configured to receive the tube when the tube is in the second position, and at least a portion of the chamber is deformable to facilitate the release of the tube from the chamber.

7. The medical system according to any one of claims 2 to 6, wherein the tube is slidably housed within the working channel of the shaft.

8. The medical system according to any one of claims 1 to 7, wherein the cap assembly is removably attached to the outer surface of the distal end of the shaft.

9. The medical system according to claim 8, wherein the cap assembly is selectively rotatable around the outer surface of the distal end of the shaft, so that the chamber can be repositioned relative to one or more channels while maintaining a state in alignment with the work channel.

10. The medical system according to any one of claims 1 to 9, wherein the porous body is a sponge, gauze, film, or membrane.

11. The medical system according to any one of claims 1 to 10, wherein the chamber is at least partially transparent so that the porous body disposed within the chamber can be seen through the chamber.

12. The medical system according to any one of claims 1 to 11, wherein the chamber includes a window, and the porous body disposed within the chamber is visible to an imaging device through the window.

13. The medical system according to any one of claims 1 to 12, wherein the chamber includes an expansion wall that defines the cross-sectional dimensions of the chamber to minimize compression of the porous body housed within the chamber.

14. The medical system according to claim 13, wherein the expansion wall is sized and shaped such that the chamber has a teardrop configuration.

15. The medical system according to any one of claims 1 to 14, wherein the cap assembly is securely attached to the shaft via a frictional engagement between the body of the cap assembly and the distal end of the shaft.

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