Medical systems, devices, and related methods for wound treatment

Abstract

A medical system comprising a handle, a shaft extending distally from the handle, and a cap assembly coupled to the distal end of the shaft. The shaft includes one or more channels extending between the handle and the distal end of the shaft, and the cap assembly includes an opening configured to expose one or more channels at the distal end of the shaft. The cap assembly includes a chamber extending distally from the opening. The medical system includes a porous body movably positioned within the chamber. The porous body is configured to transition from a compressed configuration when positioned within the chamber to an expanded configuration when extended 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, 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. The 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 the 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, a 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, a cap assembly coupled to the distal end of the shaft, the cap assembly including an opening configured to expose the one or more channels at the distal end of the shaft and a chamber extending distally from the opening, 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 chamber is configured to receive the tube when the tube is in a second position, and the chamber includes a slot configured to release the tube from the chamber. 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 to one or more 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, and the porous material placed inside the chamber is visible by an imaging device through the window. At least one of the one or more channels includes a working channel, and the window is aligned with the working channel so that the working channel is accessible at the distal end of the shaft.The cap assembly includes a body consisting of a pair of opposing halves, the body configured to receive the distal end of the shaft, and the pair of opposing halves configured to connect the cap assembly to the shaft by gripping the outside of the distal end. The cap assembly includes a fastener configured to connect the pair of opposing halves to each other, thereby securely attaching the cap assembly to 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 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.

[0007] Any medical device described herein may include any of the following features: a tube at least partially disposed within the cap assembly, 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 cap assembly to cause the porous body to extend 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 when the tube extends 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 being configured to receive the tube when the tube extends out of the chamber, and the chamber including a slot configured to release the tube from the chamber.

[0008] Another example includes a method of treating a wound cavity using a medical device, which comprises: positioning the shaft of the medical device in the wound cavity, wherein a cap assembly is mounted on the shaft so as to be positioned adjacent to the wound cavity; expanding the porous body by extending it out of the cap assembly in response to moving a tube relative to the cap assembly, the porous body exiting the cap assembly and entering the wound cavity, wherein the tube is coupled to the porous body and communicates 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.

[0009] 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]

[0010] 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 a top view of the medical device according to several embodiments. [Figure 4A] Figure 2 shows a perspective view of the medical device in a first position according to several embodiments. [Figure 4B] Figure 2 shows a perspective view of the medical device in a second position according to several embodiments. [Figure 4C]Figure 2 shows a perspective view of the medical device in a third position according to several embodiments. [Figure 4D] Figure 2 shows a perspective view of the medical device in a fourth position according to several embodiments. [Figure 5] A front view of another exemplary medical device coupled to the medical system of Figure 1, according to several embodiments, is shown. [Figure 6] Figure 5 shows front views of alternative configurations of the medical device according to several embodiments. [Modes for carrying out the invention]

[0011] 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.

[0012] 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.

[0013] 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, such as the working channel 120, 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.

[0014] 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.

[0015] 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.

[0016] 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 may form 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.

[0017] The cap assembly 200 may include a body 202 defined by a proximal end 201 and a distal end 203. In this example, the body 202 may have a cylindrical structure of a size, shape, and / or other configuration that accepts the shaft 110. In other words, the body 202 may define a channel 205 that penetrates the cap assembly 200, and the body 202 is configured to accept the shaft 110 through the channel 205 so that when the shaft 110 is accepted, the body 202 can extend around the outer surface of the shaft 110, particularly around the distal portion 118. The cap assembly 200 may be configured to restrict the movement (e.g., axial movement) of the distal tip 119 housed therein by frictional engagement of the inner surface of the body 202 defining the channel 205 with the distal portion 118 of the shaft 110. Therefore, the body 202 is configured to engage and / or grip the outside of the distal portion 118 when the distal portion 118 is received into the body 202, thereby coupling the cap assembly 200 to the shaft 110. The body 202 can define an opening 208 adjacent to the distal end 203 for receiving the distal tip 119 of the shaft 110 when the distal portion 118 is received through the channel 205 of the body 202.

[0018] In some embodiments, the proximal end 201 and the distal end 203 may include a pair of adjustment rings 204, 206 configured to move relative to each other to facilitate engagement with the shaft 110. For example, a proximal adjustment ring 204 may be defined at the proximal end 201, and a distal adjustment ring 206 may be defined at the distal end 203. Each of the adjustment rings 204, 206 may be selectively adjustable via the body 202 to receive the distal portion 118 based on the cross-sectional dimensions (e.g., diameter) of the shaft 110. In other words, the adjustment rings 204, 206 at the opposing ends 201, 203 may define a pair of opposing flexible halves of the body 202 configured to flex at least partially laterally inwardly and / or outwardly such that each can independently accommodate shafts of various cross-sectional dimensions. Thus, the proximal end 201 and the distal end 203 may be configured such that when the distal portion 118 is received within the body 202, the cap assembly 200 is coupled to the shaft 110 by engaging and / or gripping the distal portion 118 outside of the body 202.

[0019] Referring further to FIG. 2, the cap assembly 200 may include a fastening mechanism for securely attaching the body 202 to the shaft 110. The fastening mechanism may include various suitable devices for attaching the body 202 to the shaft 110, such as clips, elastic bands, O-rings, clamps, and the like. In the example shown in FIG. 2, the fastening mechanism may include a pair of protrusions 216 disposed along both sides of the body 202 and a flexible fastener 218 having both ends configured to engage each of the pair of protrusions 216. In this case, the flexible fastener 218 is configured to couple a pair of opposing halves of the body 202 (e.g., the proximal end 201 and the distal end 203) to each other with the distal portion 118 received therein, thereby securely attaching the body 202 to the shaft 110.

[0020] The cap assembly 200 may further include a chamber 210 extending distally from the body 202, more specifically from the distal end 203. The chamber 210 may have a longitudinal length defined between a first (proximal) end 211 located at the distal end 203 and a second (distal) end 212 located opposite the first end 211. In this example, the chamber 210 may have a substantially rigid configuration. 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 configuration.

[0021] Referring further to Figure 2, the chamber 210 may define a lumen 215 of a size, shape, and / or other configuration that can accommodate one or more vacuum therapy devices. For example, a vacuum therapy device may include a device configured to act on a target therapeutic site (e.g., tissue) within the subject (e.g., patient). Vacuum therapy devices include, but are not limited to, vacuum therapy sponges, gauze, films, membranes, etc., which are at least partially absorbent. In this example, a 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 liquids and / or allow liquids to pass through by negative pressure. This material may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The material of the porous body 220 may be or include open-cell foam. Suitable materials include polyurethanes, polymers having ester and / or ether functional groups, composite materials, and other medical-grade materials.

[0022] The porous body 220 may have a longitudinal length and a transverse diameter and / or width that are at least partially flexible. 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 (axially) fix the porous body 220 therein in a state where no force is applied to the porous body 220 for deployment from the chamber 210.

[0023] It should be understood that the diameter of the porous body 220 may correspond to the diameter of the inner cavity 215 of the chamber 210 in the compressed configuration. For example, the diameter of the inner cavity 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 a compressed configuration to an expanded configuration when the porous body 220 is deployed distally from the inner cavity 215 of the chamber 210 (see FIGS. 4B - 4D).

[0024] The chamber 210 may include a distal opening 213 at a second end 212 of a size and / or shape that facilitates the deployment of the porous body 220 from within 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. With the porous body 220 housed within the chamber 210, the cap assembly 200 is operable to allow the porous body 220 to be viewed from outside the chamber 210 through the window 214. In other words, the cap assembly 200 is operable to provide visual feedback of the position of the porous body 220 during a procedure in which the porous body 220 is delivered to a target therapeutic site (e.g., a wound) through the window 214 via the medical system 100 and the cap assembly 200. For example, the chamber 210 may be positioned relative to the distal tip 119 so 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 omitted entirely. 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.

[0025] Referring further to Figure 2, the cap assembly 200 may include a fluid component coupled to and communicating 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. In this example, the tubular member 230 is located outside the shaft 110 (e.g., along the radially outward direction of the shaft 110) and may extend from the proximal end 201 into the body 202. When the porous body 220 is placed inside the chamber 210, the proximal end of the porous body 220 is positioned adjacent to the distal end 203, and similarly, the end (distal end) of the tube member 230 is positioned adjacent to the distal end 203 and is positioned proximal to the first end 211. The tube member 230 is configured to move the porous body 220 distally relative to the chamber 210 (e.g., parallel movement) through the distal opening 213, for example, as the tube member 230 moves distally relative to the main body 202, thereby extending the porous body 220 outward from the chamber 210 (see Figures 4B-4D). In this case, the tube member 230 can extend distally relative to the first end 211 and reach inside the chamber 210.

[0026] 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.

[0027] Referring to Figure 3, the body 202 can be sized, shaped, and / or otherwise configured such that the chamber 210 is positioned relatively below (e.g., radially outward) one or more channels (including the working channel 120) of the shaft 110, and / or axially offset therefrom, when the cap assembly 200 is coupled to the distal portion 118. In other words, the chamber 210 can be positioned relative to the body 202 such that the chamber 210 is suspended below the opening of one or more channels of the shaft 110, so that when the body 202 is coupled to the distal portion 118, no part of the cap assembly 200 blocks the channel including the working channel 120. In this case, the opening of the working channel 120 and the other channels of the shaft 110 are accessible at the distal tip 119 through the opening 208, thereby allowing one or more medical instruments or devices (e.g., air, water, light, etc.) to extend from the shaft 110 through the channels and access the target therapeutic site through the opening 208. In some embodiments, the work channel 120 is at least partially aligned with the window 214 so that a medical instrument or device exiting the work channel 120 can extend outward from the cap assembly 200 through the window 214.

[0028] In exemplary use, as shown in Figures 4A–4D, 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 target (e.g., a patient) through the GI canal of the target (e.g., a patient) and reaches the targeted treatment site (e.g., a wound cavity). The wound cavity may be in the form of anastomosis leakage, perforation, or other damage within the GI canal. The distal tip 119, with the cap assembly 200 attached, can be positioned adjacent to, through, and / or within the wound cavity. It should be understood that once the cap assembly 200 is attached to the distal tip 119, the maneuverability of the shaft 110, such as through the control of one or more actuators on the handle 112, provides enhanced positional control when positioning the porous body 220 relative to the wound cavity. 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 (for example, using the imaging assembly 102) while the porous body 220 remains positioned inside the chamber 210.

[0029] Referring particularly to Figure 4A, 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 tubular member 230 may be in a first position, and the porous body 220 may be positioned entirely within the chamber 210. It should be understood that the first position of the tubular member 230 is the most proximal position in which the tubular member 230 is positioned outside the chamber 210. In the first position, the distal end of the tubular 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 flush with the distal end 212. By moving the tube member 230 from the first position to the second position, the deployment of the porous body 220 distally from inside the chamber 210 can begin.

[0030] As shown in Figure 4B, 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 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 outward 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 to Figure 4C, 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] Once the porous body 220 is placed in the wound cavity, negative pressure can be applied to the wound cavity through the porous body 220 by activating a negative pressure source connected to the tubular member 230. In some embodiments, with negative pressure applied through the tubular member 230, fluid in the wound cavity may flow into the porous body 220 and through the tubular 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 postoperative leakage or perforation fluid, into the porous body 220 and drawing it through the tubular 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 separated 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 brittle 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, by moving the tube member 230 to the fourth position, a force exceeding a predetermined threshold is applied 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 deforming the body 202 and / or the chamber 210 and releasing the tube member 230 from inside the chamber 210.

[0036] For example, as shown in Figure 4D, the tube member 230 can be moved to a fourth position relatively downward / radially outward until the body 202 and / or chamber 210 deform along their respective lower surfaces, forming an opening that allows the tube member 230 to exit the 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. 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 normal cylindrical sponge. Furthermore, the increased surface area and improved absorbency allow the medical system 100 (e.g., one including the porous body 220) to be maintained in the wound cavity for a longer period (i.e., fewer removals and / or replacements).

[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 5-6, 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. Referring particularly to Figure 5, cap assembly 300 may include a chamber 310 having an opening 312 formed within a first (proximal) end 211. The opening 312 may be sized, shaped, and / or otherwise configured to receive a tube member 230 into the chamber 310 through the first (proximal) end 211. In some embodiments, the opening 312 may be configured to removably secure the tube member 230 to the chamber 310. In this example, the opening 312 may be substantially C-shaped, depending on the circular and / or cylindrical cross-sectional structure of the tube member 230. It should also be understood that the cap assembly 200 may also include an opening 312 at its first (proximal) end 211 to facilitate the reception of the tubular member 230 within the chamber 210.

[0039] In this example, the chamber 310 may include a slot and / or notch 314 defining a second opening along the first (proximal) end 211. The opening 312 and the notch 314 together can define a continuous gap within the first (proximal) end 211, where the notch 314 extends downward from the opening 312 toward the bottom surface of the chamber 310. The notch 314 forms an opening along the outer circumference of the chamber 310, allowing the tube member 230 to be removed from the chamber 310. In this example, the notch 314 can define a gap with a relatively smaller cross-section than the opening 312, so that, when no force is applied to the tube member 230, the tube member 230 is at least partially prevented from moving out of the opening 312 and into the notch 314.

[0040] Referring further to Figure 5, the notch 314 may be configured to facilitate the removal of the tube member 230 from within the chamber 310 (and laterally / radially from the opening 312) without deforming the cap assembly 300, in response to the application of a downward force toward the notch 314 to the tube member 230. Thus, by pushing the tube member 230 downward relative to the opening 312, the tube member 230 can be released through the notch 314 and detached from the chamber 310. Although the opening 312 and / or notch 314 are shown and described herein as being located near the bottom surface of the first (proximal) end 211 and / or chamber 310, it should be understood that one or more of the openings 312 and / or notches 314 may be located along various other surfaces or portions of the first (proximal) end 211 and / or chamber 310.

[0041] 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. The outer sheath may include a removable portion configured to be peeled off and / or cut off from the rest of the outer sheath to facilitate the removal of the tube member 230. In other examples, the tube member 230 may include a guide wire and / or reinforcing mandrel (not shown) housed 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 the rail to facilitate the movement of the tube member 230 along the rail. In further examples, both the tube member 230 and at least one of the guide wire and / or reinforcing mandrel may be located within 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.

[0042] Referring here to Figure 6, 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 to the distal tip 119, and the position and / or orientation of the body 202 can be adjusted relative to the distal tip 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 tip 119. Thus, the chamber 310 (and the porous body 220 contained therein) can be aligned to be adjacent to a particular channel of the shaft 110, more specifically, to a particular medical instrument and / or device located within the channel, thereby facilitating access of the porous body 220 by the medical instrument and / or device. In this case, the relative position of the chamber 310 with respect to the distal end 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 the control of the porous body 220 during treatment.

[0043] 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.

[0044] 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, A cap assembly coupled to the distal end of the shaft, the cap assembly comprising an opening configured to expose one or more channels at the distal end of the shaft, and a chamber extending distally from the opening, 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 5, wherein the chamber is configured to receive the tube when the tube is in a second position, and the chamber includes a slot configured to release the tube from the chamber.

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.

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 claim 12, wherein at least one of the one or more channels includes a working channel, and the window is aligned with the working channel, thereby enabling access to the working channel at the distal end of the shaft.

14. The medical system according to any one of claims 1 to 13, wherein the cap assembly includes a body consisting of a pair of opposing halves, the body being configured to receive the distal end of the shaft, and the pair of opposing halves being configured to connect the cap assembly to the shaft by gripping the outside of the distal end.

15. The medical system according to claim 14, wherein the cap assembly is securely attached to the shaft by including fasteners configured to connect the pair of opposing halves together.

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