Medical therapy system and method of using the same

Abstract

To provide a device for treating a target therapeutic portion.SOLUTION: A medical device comprises a longitudinal body extending from a proximal end to a distal end. The longitudinal body comprises: a lumen extending from the proximal end to the distal end; and one or more openings disposed at a distal part of the longitudinal body and communicating with the lumen. The medical device includes an expandable member disposed around the distal part of the longitudinal body. The expandable member communicates with the lumen through the one or more openings. The medical device includes a string. A distal part of the string extends to the periphery of the expandable member and the string is movable relative to the expandable member so as to shift the expandable member from a shrinking state to an expanding state.SELECTED DRAWING: Figure 7A

Description

[Technical Field]

[0001] Various aspects of the present disclosure generally relate to medical vacuum therapy systems, medical vacuum therapy apparatuses, and related methods. Examples of the present disclosure relate, among other aspects, to systems, apparatuses, and related methods for removing material from a target site within a patient by generating negative pressure within the target site in the patient. [Background Art]

[0002] Endoscopic and open surgical procedures on the gastrointestinal (GI) tract include, for example, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy, among others. These procedures can result in perforation, post-operative leakage, or other wounds of the tract. Only limited therapeutic options exist for managing such wounds, and morbidity and mortality are significant. Options include surgical reoperation and endoscopic placement of stents or clips. Surgery is relatively invasive and also has high morbidity and mortality. Endoscopic stent placement is a less invasive option. However, placed stents can migrate from their intended position and / or encapsulate infection at the treatment site and impede drainage. [Summary of Invention]

[0003] Aspects of the present disclosure relate, among other things, to systems, apparatuses, and methods for treating a target treatment site using negative pressure provided by an expandable member. Each aspect disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.

[0004] In one example, the medical device includes a shaft defining a lumen and a distal portion. The distal portion of the shaft defines a side opening that communicates fluid with the lumen. The medical device includes a device coupled to the distal portion of the shaft and covering the side opening. The device includes an expandable member configured to expand laterally outward from a compressed state to an expanded state, and configured to allow fluid to pass through the expandable member and flow into the side opening. The device includes a restraint device positioned in contact with the expandable member and configured to move from a first position to a second position relative to the expandable member. The expandable member is compressed when the restraint device is in the first position, and the expandable member is expanded when the restraint device is in the second position.

[0005] Any medical device described herein may include one or more of the following features: A restraint device includes an outer tube positioned over a shaft, and an expandable member is enclosed between the shaft and the outer tube when the outer tube is in a first position. The restraint device applies a restraining force to the expandable member when the restraint device is in the first position, and the restraining force is removed when the restraint device is in a second position. The restraint device includes an inner tube positioned within the lumen of the shaft and a distal tip extending distally to the distal end of the shaft. The proximal portion of the distal tip is coupled to the distal portion of the expandable member. The application of a proximal force to the inner tube causes the expandable member to shorten longitudinally and expand laterally outward. The shaft includes a slot, which is close to the distal end of the shaft and extends into the lumen of the shaft. The restraint device includes a thread extending outward from the lumen of the shaft through the slot, which is attached to the distal end. The proximal portion of the thread extends into the lumen, while the distal portion of the thread is positioned over the outer surface of the distal portion of the shaft and extends around the expandable member. The distal portion of the thread includes one or more knots connecting the thread to the expandable member. The one or more knots are configured to break or unravel in response to a proximal force applied to the thread. A locking mechanism is further included, which is configured to fix a restraining device to the expandable member, thereby maintaining the restraining device in at least one of a first or second position, and to maintain the expandable member in at least one of an expanded or compressed state. A pressure source is further included, which is in fluid communication with the lumen. The pressure source is configured to generate suction at the distal portion of the shaft through a side opening so that fluid located adjacent to the distal portion is drawn through the expandable member into the lumen. The expandable member includes a porous body comprising a plurality of fibers. The expandable member has a larger diameter in the expanded state than in the compressed state. The expandable member is fixed to the shaft along its entire length.

[0006] In another example, a medical device includes a shaft defining a lumen along its longitudinal axis, the shaft having at least one opening within its outer surface, the at least one opening being in fluid communication with the lumen. The medical device includes a porous body positioned on the at least one opening of the shaft and configured to expand laterally outward with respect to the longitudinal axis. The medical device includes a restraining member that engages with and is movable relative to the porous body, the restraining member configured to apply a binding force to the porous body. After the restraining member has transitioned the porous body from a compressed state to an expanded state, the shaft is configured to receive fluid into the lumen through the opening and the porous body.

[0007] Any medical device described herein may include one or more of the following features: The porous material has a smaller cross-sectional diameter around its longitudinal axis when compressed than when expanded. The porous material is a sponge having a porosity that allows fluid to pass through within the porous material.

[0008] Another example relates to a method for drawing fluid using a medical device, the medical device comprising a shaft, an expandable porous body positioned along the shaft, and a restraining device in contact with the expandable porous body, the method comprising moving the restraining device relative to the expandable porous body to allow the expandable porous body to expand around the shaft. The method comprises applying suction through the shaft and drawing fluid into the shaft through the expandable porous body and through one or more openings positioned between the expandable porous body and the shaft.

[0009] It should be understood that both the above summary and the following embodiments for carrying out the invention are merely illustrative and descriptive, and do not limit the claimed invention. The accompanying drawings incorporated herein and forming part of this specification illustrate exemplary embodiments of the disclosure and, together with the specification, serve to illustrate the principles of the disclosure. [Brief explanation of the drawing]

[0010] [Figure 1] A perspective view of an exemplary medical system including an outer tube and an inner tube according to an aspect of the present disclosure. [Figure 2A] A cross-sectional side view of an inner tube, arranged inside the outer tube of Figure 1, according to an aspect of the present disclosure, in which the inner tube includes an absorption device. [Figure 2B] A cross-sectional side view of the inner tube extending from the outer tube in Figure 1, in which the absorption device is in an expanded state, according to an aspect of the present disclosure. [Figure 3] A schematic diagram of the outer tube of Figure 1, positioned on the target site of the subject, according to an aspect of this disclosure. [Figure 4A] A cross-sectional side view of the inner tube of Figure 1, which is located inside another exemplary outer tube containing an absorption device, according to an aspect of the present disclosure. [Figure 4B] A cross-sectional side view of the outer tube of Figure 4A, which moves relative to the inner tube, with the absorption device in an expanded state, according to an aspect of the present disclosure. [Figure 5] A partial perspective view of another exemplary inner tube, including a restraining device and a compressed absorbent member, according to an aspect of the present disclosure. [Figure 6] A partial perspective view of the inner tube of Figure 5, having a restraint device and an absorbent member in an expanded state, according to an aspect of the present disclosure. [Figure 7A] A cross-sectional side view of the inner tube of Figure 5, having a restraining device and an absorbent member in a compressed state, according to an aspect of the present disclosure. [Figure 7B] A cross-sectional side view of the inner tube of Figure 5, having a restraining device and an absorbent member in an expanded state, according to an aspect of the present disclosure. [Modes for carrying out the invention]

[0011] Endoluminal vacuum therapy (EVAC) has been proposed. In EVAC, negative pressure is delivered to the wound site in the gastrointestinal tract, for example, through a nasogastric tube with a sponge at its terminal end. The sponge is endoscopically placed in the perforation, leakage, or other wound. Negative pressure is then applied. However, suitable devices and systems for EVAC are limited.

[0012] Examples of the present disclosure include systems, apparatus, and methods for removing material from a target site within a subject (e.g., a patient) by generating negative pressure within the target site within the subject (e.g., a patient). Embodiments of the present disclosure include apparatus, systems, and methods for intraluminal vacuum therapy (EVAC). In this example, EVAC includes intraluminal placement of a porous material, such as a sponge or other similar material, into a wound site including a perforation, cyst, leakage, or anastomosis. Placement of the material may be via a catheter, scope (such as an endoscope, bronchoscope, or colonoscope), tube, or sheath inserted into the gastrointestinal tract through a natural opening. The opening may be, for example, the nose, mouth, or anus, and placement may be within any part of the gastrointestinal tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Placement may also be within other organs accessible via the gastrointestinal tract.

[0013] Hereinafter, aspects of this disclosure are referenced in detail, examples of which are shown in the accompanying drawings. Wherever possible, the same or similar reference numerals are used throughout the drawings to refer to the same or similar parts. The term “distal” refers to the part of the device that is furthest from the user when the device is introduced to the patient. In contrast, the term “proximal” refers to the part of the device that is closest to the user when the device is positioned on the subject. Where used herein, the terms “comprises,” “comprising,” or any other variation thereof are intended to include non-exclusive inclusion, such that a process, method, article, or device containing a list of elements does not necessarily contain only these elements and may include other elements not expressly listed or that are specific to such process, method, article, or device. The term “exemplary” is used in the sense of “example” rather than “ideal.” Where used herein, the terms “about,” “substantially,” and “approximately” indicate a range of values ​​within + / - 10% of the stated value.

[0014] Examples of the present disclosure may be used to treat a target site where leakage is occurring by negative pressure wound therapy. For example, in some embodiments, a delivery tube and a porous body and / or absorbent may be combined to remove any substance (e.g., fluid, mass, etc.) from the target site and to dry the surrounding tissue of any leakage. The porous body and / or absorbent may be positioned along the body of the delivery tube and, in some examples, may be in fluid communication with the lumen of the delivery tube. The porous body and / or absorbent may be selectively expandable between a compressed default state and an expanded operating state. Furthermore, the porous body and / or absorbent may be constrained to the compressed default state by one or more other components, including, for example, an outer sheath positioned on the absorbent, a delivery tube of a certain length, and / or a restraining device coupled to the porous body and / or absorbent. The porous body and / or absorbent may be configured to extract material from within the target site when in the expanded operating state.

[0015] Examples of the present disclosure may relate to devices and methods for performing various medical procedures and / or treating the large intestine (colon), small intestine, cecum, part of the esophagus, any other part of the gastrointestinal tract, and / or any other appropriate anatomical structure of a patient (collectively referred to herein as “Target Therapy Sites”). The various examples described herein include single-use or disposable medical devices. Hereinafter, examples of the present disclosure shown above and in the accompanying drawings will be referred to in detail. Wherever possible, the same reference numerals will be used throughout the drawings to refer to identical or similar parts.

[0016] Figure 1 shows a schematic diagram of an exemplary medical system 100 according to an example of the present disclosure. The medical system 100 may include a medical instrument 110, a medical device 130, a pressure regulator 132, and a collection container 136. The medical instrument 110 may be configured to facilitate positioning of one or more components of the medical system 100, such as the medical device 130, to a person (e.g., a patient). In embodiments, the medical instrument 110 may be any type of endoscope, duodenoscope, gastroscopy, colonoscope, ureteroscope, bronchoscope, catheter, or other delivery system, and may include a handle 112, an operating mechanism 114, at least one port 116, and a shaft 120. The handle 112 of the medical instrument 110 may have one or more lumens (not shown) that communicate with lumens of one or more other components of the medical system 100. The handle 112 further includes at least one port 116 that leads to one or more lumens of the handle 112. As will be described in more detail herein, at least one port 116 is made to be of a size and shape that can receive therein one or more instruments, such as medical devices 130 of a medical system 100.

[0017] The shaft 120 of the medical device 110 may include a tube. The tube is sufficiently flexible and the shaft 120 is configured to selectively bend, rotate, and / or twist as it is inserted into and / or passes through the meandering anatomical structure of the subject to reach the target therapeutic site. The shaft 120 may have one or more lumens (not shown) extending therein. One or more lumens (not shown) may include, for example, a working lumen for receiving an instrument (e.g., medical device 130). In other examples, the shaft 120 may include additional lumens such as a control wire lumen for receiving one or more control wires for acting on one or more distal parts / tools (e.g., articular joints, dissectors, etc.), a fluid lumen for delivering fluid, an illumination lumen for receiving at least a portion of an illumination assembly (not shown), and / or an imaging lumen for receiving at least a portion of an imaging assembly (not shown).

[0018] Referring further to Figure 1, the medical device 110 may further include a tip 122 at the distal end of the shaft 120. In some embodiments, the tip 122 may be attached to the distal end of the shaft 120, and in other embodiments, the tip 122 may be integral with the shaft 120. For example, the tip 122 may include a cap configured to receive the distal end of the shaft 120. The tip 122 may define one or more openings communicating with one or more lumens of the shaft 120. For example, the tip 122 may include a working opening, through which the medical device 130 can exit the working lumen of the shaft 120.

[0019] In another example, the tip 122 of the shaft 120 may include additional and / or fewer openings. The openings are, for example, fluid openings or nozzles capable of discharging fluid from the fluid lumen of the shaft 120, illumination openings / windows through which light can be emitted, and / or imaging openings / windows for receiving light used by an imaging device to generate an image. The actuation mechanism 114 of the medical instrument 110 is disposed on the handle 112 and may include one or more knobs, buttons, levers, switches, and / or other suitable actuators. The actuation mechanism 114 is configured to control at least one of deflection of the shaft 120 (e.g., via actuation of a control wire), fluid delivery, emission of illumination, and / or various imaging functions.

[0020] With further reference to FIG. 1, the medical device 130 of the medical system 100 may include a catheter (e.g., a multi-lumen catheter) having a longitudinal body extending between a distal end and a proximal end. In this example, the medical device 130 includes an inner tube 140 and an outer tube 150, the inner tube 140 is disposed within the outer tube 150 and coaxially aligned with the outer tube 150. In this example, the longitudinal body 142 of the inner tube 140 is longer than the longitudinal body 152 of the outer tube 150. For example, in some embodiments, the longitudinal body 142 of the inner tube 140 may be twice the length of the longitudinal body 152 of the outer tube 150, although other relative lengths are also contemplated (e.g., four times, five times, or more).

[0021] The longitudinal bodies 142, 152 are flexible such that the medical device 130 is configured to bend, rotate, and / or twist when inserted into the working lumen of the medical instrument 110. As described in detail herein, the medical device 130 may include one or more hubs 148, 158 (FIGS. 2A-2B) attached to and adjacent proximal ends 146, 156, respectively, for actuating the inner tube 140 and the outer tube 150 relative to each other. For example, the hubs 148, 158 of the medical device 130 may be configured to move, rotate, and bend the longitudinal bodies 142, 152 of the tubes 140, 150, and / or move the tubes 140, 150 relative to each other. The hub 148 may be configured and operable to control the longitudinal body 142 of the inner tube 140, and the hub 158 may be configured and operable to control the longitudinal body 152 of the outer tube 150.

[0022] With further reference to FIG. 1, the proximal end 146 may define one or more ports (not shown) sized to receive one or more tools within the longitudinal body 142. The proximal end 146 of the inner tube 140 may be fluidly coupled to the collection container 136 of the medical system 100 such that the inner tube 140 and / or the outer tube 150 can be in fluid communication with the collection container 136. In this example, the lumen of the inner tube 140 may be fluidly coupled to the collection container 136 at the proximal end 146. The collection container 136 of the medical system 100 may define a cavity that is sized, shaped, and configured to receive one or more substances from the medical device 130. As described in greater detail herein, the collection container 136 may be configured to store substances retrieved at the distal end 144 by the medical device 130.

[0023] The collection container 136 of the medical system 100 may be fluidically coupled to one or more other components of the medical system 100, such as a pressure regulator 132. In this example, the pressure regulator 132 may be in fluid communication with the collection container 136 via a connection port 134 located between the pressure regulator 132 and the collection container 136. The pressure regulator 132 may be configured and operable to generate negative pressure within the medical system 100. In this example, the pressure regulator 132 (e.g., a pressurizing cylinder) can create a vacuum within the medical system 100 through the collection container 136. The lumen and distal end 144 of the inner tube 140 may be pressurized through the proximal end 146 of the inner tube 140. As described in more detail herein, the pressure regulator 132 may generate a pressure change within the medical device 130 to extract one or more substances (e.g., fluids) adjacent to and / or outside the distal end 144 through the inner tube 140 to the collection container 136.

[0024] The medical device 110 is configured to receive the medical device 130 through at least one port 116, through a working lumen, through the shaft 120, and to the working opening of the tip 122. In this example, as will be described in more detail below, the medical device 130 may extend distally from the working opening of the tip 122 and may extend to the external environment surrounding the tip 122, such as a target treatment site of a patient. The outer tube 150 may extend distally from the working opening of the tip 122 in response to the longitudinal movement of the medical device 130 through the working lumen of the shaft 120.

[0025] In addition, the inner tube 140 of the medical device 130 is positioned within the lumen of the outer tube 150, so that it can extend distally from the working opening of the tip 122 together with the outer tube 150 in response to the movement of the medical device 130 through the working lumen of the shaft 120 (i.e., tubes 140 and 150 can move simultaneously). In this example, the inner tube 140 should be understood to be positioned within the lumen of the outer tube 150 such that the distal end 144 of the inner tube 140 is positioned proximal to the distal end 154 of the outer tube 150.

[0026] Referring further to Figure 1, the medical device 130 may further include a device at the distal end 144 of the inner tube 140. In this example, the device of the medical device 130 may include an expandable member 160. The expandable member 160 may be located at the distal end 144 of the inner tube 140 and / or may extend distally to the distal end 144 of the inner tube 140. In some embodiments, the expandable member 160 may include an absorption device coupled to the distal end 144 of the inner tube 140. In this example, the expandable member 160 may be located along the side wall and / or outer surface of the longitudinal body 142 of the inner tube 140.

[0027] In other embodiments, the expandable member 160 may be positioned along the surface of various other inner tubes 140 and / or portions of the medical device 130 without departing from the scope of the present disclosure. The majority or all of the expandable member 160 may be positioned proximal to the most distal end of the distal end 144 of the inner tube 140. In other embodiments, at least a portion and / or all of the expandable member 160 may extend distally to the distal end 144 of the inner tube 140.

[0028] Referring here to Figure 2A, the expandable member 160 may include a porous body comprising a plurality of flexible and / or compressible fibers. In embodiments of the present disclosure, the porous body may include a sponge and / or foam. The sponge and / or foam may be any suitable biocompatible material capable of absorbing and / or passing liquid by negative pressure, such as from a pressure regulator 132 of a medical system 100. The material of the porous body (e.g., plurality of fibers) of the expandable member 160 may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. Furthermore, the sponge material of the porous body may be an open-cell foam. Suitable materials may include, for example, polyurethane, esters, ethers, composite materials, absorbent polymer powders, micro / nanoporous materials, and any medical-grade materials.

[0029] In this example, the porous body of the expandable member 160 may define a mesh formed by multiple fibers. In this example, the expandable member 160 may be configured and actuated to expand selectively. In other words, the volumetric capacity of the expandable member 160 may be selectively adjusted. By forming a sponge and / or foam, the expandable member 160 may be configured to allow one or more substances (e.g., fluids) to pass through and / or be delivered to the porous body of the expandable member 160.

[0030] Referring further to Figure 2A, as described above, the medical device 130 includes one or more hubs 148, 158 (e.g., handles) for grasping and operating the tubes 140, 150 by hand. In this example, the inner tube 140 may include a proximal hub 148 at and / or near the proximal end 146 of the inner tube 140 along the longitudinal body 142, and the outer tube 150 may include a proximal hub 158 at and / or near the proximal end 156 of the outer tube 150 along the longitudinal body 152. In this example, the proximal hubs 148, 158 of the tubes 140, 150 may be coupled to the longitudinal bodies 142, 152, respectively. As further described herein, one or more of the proximal hubs 148, 158 may include luers that can connect the tubes 140, 150 to the collection container 136 and / or the pressure regulator 132. In some embodiments, the proximal hubs 148, 158 may be selectively detachable from the longitudinal bodies 142, 152 of the tubes 140, 150, respectively. For example, the proximal hub 148 of the inner tube 140 may be detachably coupled to the proximal end 146 of the longitudinal body 142 so that the proximal hub 148 can be configured to separate from the inner tube 140.

[0031] In this example, the longitudinal body 142 of the inner tube 140 may define a lumen 141 extending between the distal end 144 and the proximal end 146. As described in detail above, the proximal end 146 of the inner tube 140 may be fluidically coupled to the collection container 136 and the pressure regulator 132 via the proximal hub 148 so that the lumen 141 of the inner tube 140 is in fluid communication with the collection container 136 and the pressure regulator 132. The distal end 144 of the inner tube 140 is closed, thereby terminating the lumen 141 of the longitudinal body 142 inside it. In other words, in some embodiments, it is not possible to transport fluid through the distal end 144. However, in other embodiments, it is assumed that the distal end 144 of the inner tube 140 is open, thereby allowing the transport of fluid through the distal end 144.

[0032] Furthermore, the longitudinal body 152 of the outer tube 150 may define a lumen 151 extending between the distal end 154 and the proximal end 156 of the outer tube 150. The distal end 154 and the proximal end 156 of the outer tube 150 may each be sized and shaped to slidably receive the longitudinal body 142 of the inner tube 140, and may form an opening configured in such a way. In this example, the inner tube 140 may be received into the lumen 151 of the outer tube 150 through the opening at the proximal end 156, and may extend distally and / or outward from the lumen 151 through the opening at the distal end 154 of the outer tube 150.

[0033] Referring further to Figure 2A, the inner tube 140 of the medical device 130 may further include one or more openings 143. The openings 143 are located along the outer wall of the longitudinal body 142 and adjacent to the distal end 144. In this example, the inner tube 140 may include a plurality of openings 143. The plurality of openings 143 extend along the distal portion of the longitudinal body 142. The distal portion of the longitudinal body 142 coincides with the location of the expandable member 160 in the longitudinal direction. The plurality of openings 143 may pass through the longitudinal body 142 and extend into the lumen 141 of the inner tube 140. It should be understood that, by positioning the expandable member 160 along the outside of the longitudinal body 142 and positioned over the plurality of openings 143, the porous material of the expandable member 160 can be in fluid communication with the lumen 141 of the inner tube 140 through the plurality of openings 143. The opening 143 may include a variety of suitable sizes, shapes, and / or configurations. In some embodiments, the opening 143 of the inner tube 140 may be micron-sized (e.g., micrometers), but other suitable dimensions are also possible (e.g., millimeters, centimeters, etc.).

[0034] It should be understood that, by positioning the inner tube 140 within the lumen 151 of the outer tube 150, the inner surface of the longitudinal body 152 may be operable to constrain the size, shape, contour, and / or configuration of the expandable member 160. In other words, the outer tube 150 may be a restraining device configured to contact and / or engage with the expandable member 160, thereby compressing the porous body of the expandable member 160 into a compressed state. As further detailed and described herein, the medical device 130 may be configured such that by removing the outer tube 150 covering the expandable member 160, the restraining / binding force applied to the expandable member 160 by the longitudinal body 152 is stopped, allowing the porous body of the expandable member 160 to expand outward (Figure 2B) into its restrained / biased state.

[0035] Referring here to Figure 2B, an inner tube 140 is schematically shown with the proximal hub 148 omitted from the proximal end 146. As briefly described above, the proximal hub 148 may be a removable lure and / or hub, so that it may be configured to be separated from the longitudinal body 142. In this example, the removal of the proximal hub 148 from the longitudinal body 142 may allow the proximal movement of the outer tube 150 relative to the inner tube 140. If the proximal hub 148 is included along the proximal end 146 of the longitudinal body 142, it should be understood that the presence of the proximal hub 148 on the proximal end 146 of the longitudinal body 142 may prevent the proximal movement of the outer tube 150 beyond the proximal end 146 of the inner tube 140. In other words, when the outer tube 150 moves proximal, the proximal hub 148 of the inner tube 140 engages with and / or abuts against the proximal hub 158 of the outer tube 150, thereby fixing the outer tube 150 to the inner tube 140 (and effectively functioning as a stopper).

[0036] As the proximal hub 148 of the inner tube 140 is separated from the proximal end 146 of the longitudinal body 142, the outer tube 150 can move proximal enough so that the expandable member 160 can extend outward from the lumen 151 of the longitudinal body 152. In this example, the restraining force on the expandable body 160 by the outer tube 150 is removed, thereby allowing the expandable body 160 to expand radially, proximal, and / or distally outward relative to the inner tube 140. The expandable body 160 can extend laterally outward relative to and around the longitudinal body 142 such that it has a larger diameter when expanded than when compressed (Figure 2A).

[0037] Referring further to Figure 2B, it should be understood that when the expandable body 160 is in the expanded state, the expandable body 160 may remain fixed to the longitudinal body 142 of the inner tube 140. In this example, when transitioning from the compressed state (Figure 2A) to the expanded state, the entire length of the porous body of the expandable member 160 is fixed to the longitudinal body 142 and maintained over the multiple openings 143. Therefore, when stretched to the expanded state, the porous body of the expandable member 160 may remain in fluid communication with the lumen 141 of the inner tube 140 through the multiple openings 143. As described in more detail herein, when the expandable member 160 is in an expanded state, the plurality of openings 143 may be configured and operable to allow one or more substances (e.g., solids, fluids, etc.) to be removed from or outside the porous body, or to allow one or more substances (e.g., solids, fluids, etc.) from inside or outside the porous body to flow through the porous body of the expandable member 160 and enter the lumen 141 of the inner tube 140 (through the plurality of openings 143).

[0038] Referring here to Figure 3, an exemplary method of using the medical system 100 to treat a target site within a subject 10 (e.g., a patient) is schematically shown. For example, the shaft 120 of the medical instrument 100 may be guided through the digestive tract of the subject 10 by inserting the tip 122 into the nose 12 or mouth 14 (or other suitable natural orifice) of the subject's body 10. In embodiments, the medical instrument 110 may be inserted through the gastrointestinal tract of the subject's body 10, including the esophagus 16, stomach 18, and / or intestinal tract 20 (e.g., small intestine, large intestine), until it reaches the target treatment site. The length of the shaft 120 should be understood to be sufficient so that the proximal end of the medical instrument 110 (including the handle 112) is outside the subject's body 10 while the tip 122 of the medical instrument 110 is inside the subject's body 10.

[0039] In this example, the target treatment site 22 within the subject's body 10 may be located along the gastrointestinal tract within the esophagus 16. The target treatment site 22 may include, for example, an anastomotic leakage or perforation of the esophagus 16 or other part of the gastrointestinal tract, such as a wound resulting from a surgical procedure performed (e.g., colectomy, bariatric surgery, esophagectomy, etc.). While this disclosure relates to the use of the medical system 100 within the digestive tract within the subject's body 10, it should be understood that the features of this disclosure can be used in various other locations within the subject's body 10 (e.g., other organs, tissues, etc.). In some examples, the shape and / or size of the porous body of the expandable member 160 may be adjusted by the user (e.g., by hand) before the medical device 130 is implanted in the subject 10.

[0040] Referring further to Figure 3, the shaft 120 of the medical device 110 may be extended into the subject's body 10 until the tip 122 of the shaft 120 reaches a position near the target treatment site 22 (e.g., anastomotic leakage or perforation). It should be understood that the medical device 130 (e.g., tubes 140, 150) may be received into the medical device 100, for example, within the shaft 120, through the port 116, before and / or after the insertion of the medical device 110 into the subject's body 10. With the tip 122 of the shaft 120 positioned adjacent to the target treatment site 22 and the medical device 130 positioned within the target treatment site 22, the medical device 130 may be operated to extend the outer tube 150 and / or inner tube 140 distally from the tip 122 of the shaft 120 (e.g., at the proximal hubs 148, 158). In this example, the distal end 154 of the outer tube 150 extends outward from the lumen of the shaft 120.

[0041] With the outer tube 150 positioned within the esophagus 16 (or gastrointestinal tract) and adjacent to the target treatment site 22, the user may activate one or more components of the medical device 110 and / or medical apparatus 130 to position the distal end 154 of the outer tube 150 within or adjacent to the target treatment site 22 (e.g., anastomotic leakage or perforation). For example, the proximal hub 158 of the medical apparatus 140 (Figures 2A-2B) may be activated to articulate (e.g., change direction, bend, or oscillate) the distal end 154 of the outer tube 150 relative to the tip 122 of the shaft 120. In this example, the distal portions of the outer tube 150 (and the inner tube 140 received within the outer tube 150) may be moved into the perforation of the target treatment site 22, with the remainder of the longitudinal bodies 142 and 152 of the tubes 140 and 150 positioned outside the target treatment site 22. In this example, the expandable body 160 of the medical device 130 should be understood to be positioned within the target treatment site 22 in a contracted and / or compressed state (Figure 2A). Alternatively, the distal end 154 of the outer tube 150 may be positioned adjacent to the target treatment site 22 and retracted to expand the expandable member 160. In this example, the expandable member 160 may be moved within the target treatment site 22.

[0042] Referring further to Figure 3, when the medical device 130 is placed at the target treatment site 22, the shaft 120 of the medical device 110 can be withdrawn from the esophagus 16 (gastrointestinal tract) of the subject's body 10. With the distal ends 144, 154 of the tubes 140, 150 positioned within the target treatment site 22 (e.g., anastomotic leakage or perforation), the proximal ends 146, 156 of the tubes 140, 150 can be positioned outside the subject's body 10. In this example, the proximal hubs 148, 158 of the tubes 140, 150 may be accessible to the user of the medical system 100. For example, the proximal hub 148 of the inner tube 140 can be detached from the proximal end 146 of the longitudinal body 142 to facilitate the removal of the outer tube 150 that covers the inner tube 140.

[0043] In some embodiments, while the inner tube 140 is being inserted into the esophagus 16 (gastrointestinal tract), the inner tube 140 is not coupled to the pressure regulator 132. In this example, after the removal of the proximal hub 148, a different hub may be attached to the proximal end 146 to fluidly couple the inner tube 140 to the pressure regulator 132. In other embodiments, the proximal hub 148 may be reattached to the proximal end 146 and configured to fluidly couple the inner tube 140 to the pressure regulator 132. In some embodiments, removing the proximal hub 148 from the proximal end 146 of the longitudinal body 142 may isolate the fluid communication between the lumen 141 of the inner tube 140 and the collection container 136 and / or the pressure regulator 132. In this example, the proximal retraction of the proximal hub 158 of the outer tube 150 can expose the distal end 144 of the inner tube 140 from the lumen 151, so that the expandable member 160 extends distally from the distal end 154 of the longitudinal body 152.

[0044] The porous material of the expandable member 160 can continuously transition from a compressed state (Figure 2A) to an expanded state (Figure 2B) as the outer tube 150 moves proximal to the second position (Figure 2B) from the first position (Figure 2A). The inner tube 140 of the medical device 130 should be understood to remain in a fixed position relative to the target treatment site 22 as the outer tube 150 moves. In other embodiments, the inner tube 140 may extend distally toward the outer tube 150 and / or toward the target treatment site 22.

[0045] Referring again to Figure 2B, with the expandable member 160 in the expanded state and the distal end 144 of the longitudinal body 142 positioned within the target treatment site 22, the porous body of the expandable member 160 may be in contact with the surrounding tissue defining the target treatment site 22, or otherwise positioned within the target treatment site 22. In this example, the expandable member 160 may be configured to absorb one or more substances (e.g., fluids, solids, etc.) within the target treatment site 22. For example, the porous body of the expandable member 160 may absorb fluids within the target treatment site 22, thereby drying the surrounding tissue defining the target treatment site 22. In some embodiments, the expandable member 160 may further be configured to change the path of one or more substances within the target treatment site 22 (e.g., push, reposition, move, remove, displace, or eliminate) as it stretches outward into the expanded state.

[0046] Furthermore, the expandable member 160 can apply force and / or generate pressure within the target treatment site 22 and on any material within the target treatment site 22 in response to the expansion of the porous body of the expandable member 160. In some embodiments, the outer tube 150 can be completely detached from the inner tube 140 (and from the patient) so that the proximal end 146 of the longitudinal body 142 may be accessible to the user of the medical system 100. In this example, the proximal hub 148 (and / or another Luer / hub connector) may be coupled to the proximal end 146 of the inner tube 140. With the proximal hub 148 coupled to the longitudinal body 142 of the inner tube 140, the collection container 136 and / or pressure regulator 132 may be fluidically coupled to the lumen 141 of the inner tube 140 via the proximal hub 148.

[0047] With the lumen 141 of the inner tube 140 fluidly coupled to the pressure regulator 132, the lumen 141 may be configured and operable to transport one or more substances (e.g., fluids, body matter, etc.) from the target treatment site 22 to the collection container 136 via the expandable body 160 and the multiple openings 143 (e.g., by aspirating, removing, pulling, drawing, etc.) in response to the operation of the pressure regulator 132. In this example, one or more substances within the target treatment site 22 may move around and / or through the porous body of the expandable member 160. In other words, the pressure regulator 132 generates negative pressure within the target treatment site 22 through the multiple openings 143.

[0048] One or more substances within the target treatment site 22 (e.g., leakage or perforation) may include a variety of solids, liquids, and / or other substances received into the target treatment site 22 from the subject's gastrointestinal tract. It should be understood that the presence of such substances within leakage and / or perforation in the gastrointestinal tract may prevent the recovery and / or healing of the target treatment site. Therefore, one or more substances within the cavity of the target treatment site 22 may be drawn into the lumen 141 of the inner tube 140 through the porous body of the expandable member 160.

[0049] Referring again to Figure 1, with the proximal end 146 of the inner tube 140 fluidly coupled to the collection container 136, any substance and / or fluid received into the lumen 141 from the target treatment site 22 can be placed into the collection container 136. The collection container 136 and the pressure regulator 132 should be understood to be positioned and / or configured such that, as the collection container 136 stores one or more substances and / or fluids within it, the pressure regulator 132 can continue to generate negative pressure in the lumen 141 of the inner tube 140 through the collection container 136.

[0050] For example, a connecting port 134 connecting the collection container 136 and the pressure regulator 132 may be positioned along the upper portion of the collection container 136 so as fluid communication between the collection container 136 and the pressure regulator 132 is maintained when the lower portion of the collection container 136 receives material and / or fluid into it. In other embodiments, the collection container 136 and the pressure regulator 132 may be separated from each other and coupled to the proximal end 146 of the inner tube 140 via various other suitable configurations other than those shown and described herein. Upon completion of the procedure, the pressure regulator 132 may be deactivated, thereby stopping aspiration within the target treatment site 22 via the inner tube 140.

[0051] Referring further to Figure 1, when the inner tube 140 is withdrawn through the esophagus 16 (gastrointestinal tract) (for example, from the outside through the nose 12 and / or mouth 14), the porous body of the expandable member 160 can be adjusted (e.g., compressed) against the wall of the esophagus 16, for example, as the inner tube 140 is retracted within the esophagus 16. In some embodiments, the outer tube 150 of the medical device 130 is repositioned on the longitudinal body 142 of the inner tube 140 (for example, before withdrawal), thereby enclosing the expandable member 160 in the lumen 151 and facilitating the removal of the medical device 130 from the subject 10.

[0052] Referring here to Figures 4A and 4B, another exemplary medical device 230 according to an example of the present disclosure is shown. Unless otherwise noted below, medical device 230 may be substantially similar to medical device 130 described above, and the same reference numerals are used to identify similar components. It should be understood that medical device 230 may be configured and operable in the same way as medical device 130, and that medical device 230 may be readily incorporated into the medical system 100 described above.

[0053] For example, referring first to Figure 4A, the medical device 230 may include an outer tube 250 having a longitudinal body 152 defined between a distal end 154 and a proximal end 156. The outer tube 250 may be directly coupled to the proximal end of an expandable member 160 at the distal end 154. In this example, the proximal end of the expandable member 160 may be fixed to the distal end 154 of the outer tube 250 so that the expandable member 160 can be aligned with the longitudinal body 152 of the outer tube 250. In other words, the expandable member 160 may extend distally from the distal end 154 of the outer tube 250, and the longitudinal length of the expandable member 160 is the stretch range of the longitudinal body 152 of the outer tube 250. In this example, the expandable member 160 may be aligned with the lumen 151 of the outer tube 250 and define the distal lumen 161.

[0054] The outer tube 250 may include a proximal hub 158 at the proximal end 156 of the longitudinal body 152. In this example, the proximal hub 158 of the outer tube 250 may include a locking mechanism 157 positioned along the inner surface of the proximal hub 158 such that the locking mechanism 157 extends toward and / or at least partially into the lumen 151. As described in further detail herein, the locking mechanism 157 of the outer tube 250 may be configured and actuated to engage with the inner tube 140 of the medical device 230 in order to secure the longitudinal body 152 to the longitudinal body 142 of the inner tube 140. In some embodiments, the locking mechanism 157 may include, for example, a hemostatic valve, a rubber gasket (e.g., an O-ring), and / or various other suitable locking mechanisms.

[0055] Referring further to Figure 4A, the inner tube 140 of the medical device 230 may be positioned within the lumen 151 of the outer tube 250 and the lumen 161 of the expandable member 160. In this example, the inner tube 140 may include a longitudinal body 142 defined between the distal end 145 and the proximal end 146. In this example, the distal end 145 extends distally to the distal end 154 of the outer tube 250 and the distal end of the expandable member 160. Furthermore, the distal end 145 of the inner tube 140 may be made to have a cross-sectional dimension larger than the cross-sectional dimensions of the lumens 151 and 161. The distal end of the expandable member 160 may be directly coupled and fixed to the distal end 145 of the inner tube 140.

[0056] In the example shown in Figure 4A, the distal end 145 of the inner tube 140 may be positioned in the most distal range (e.g., a first position) relative to the outer tube 250 so that the expandable member 160 is maintained in a compressed state. In this example, the longitudinal body of the expandable member 160 may be extended between the distal ends 145 and 154 of the tubes 140 and 250. As further described herein, the expandable member 160 is configured to move relative to the outer tube 250 in response to the movement of the inner tube 140 relative to the outer tube 250.

[0057] In other words, the distal end 145 of the inner tube 140 may be a restraining device configured to abut against the distal end of the expandable member 160. In this example, the expandable member 160 may be operable to transition from a compressed state to an expanded state (Figure 4B) in response to the movement of the inner tube 140 relative to the outer tube 250 (e.g., to a second position). The porous body of the expandable member 160 should be understood to have a smaller profile, cross-sectional dimensions, diameter, etc., and a longer longitudinal length when compressed than when expanded.

[0058] Referring here to Figure 4B, the proximal hub 148 of the inner tube 140 moves proximal to the proximal end 156 of the longitudinal body 152, causing the distal end 145 of the inner tube 140 to move proximal to such an extent (e.g., to a second position) that the expandable member 160 is engaged by the distal end 145 and compressed longitudinally. In this example, the expandable member 160 can be stretched radially outward relative to the longitudinal body 152 of the outer tube 250. In this example, the distal end 145 generates a restraining force on the expandable member 160, thereby causing the expandable member 160 to expand radially outward. The expandable member 160 can stretch laterally / radially outward relative to the distal end 154 of the outer tube 250 such that when the expandable member 160 is in an expanded state (Figure 4A) it forms a larger profile, cross-sectional dimensions, diameter, etc., and a shorter longitudinal length than when it is in a compressed state.

[0059] It should be understood that the expandable body 160 may remain fixed to the distal end 154 of the longitudinal body 152 when in the expanded state. In this example, the proximal movement of the distal end 145 of the inner tube 140 compresses the expandable body 160 between the distal end 154 of the outer tube 250 and the distal end 145 of the inner tube 140. In other words, in response to the movement of the inner tube 140 relative to the outer tube 250, the entire length of the porous body of the expandable member 160 is sandwiched between the distal ends 145 and 154. In other embodiments, the expandable body 160 may transition to an expanded state in response to the distal movement of the outer tube 250 relative to the inner tube 140.

[0060] Referring further to Figure 4B, with the expandable member 160 in the expanded state, the proximal hub 158 of the outer tube 250 may be actuated to maintain the expandable member 160 in the expanded state by locking the outer tube 250 to the inner tube 140. For example, applying a lateral (e.g., inward) force to the proximal hub 158 may cause movement of the proximal hub 158 and / or the distal end 154 of the longitudinal body 152 relative to the inner tube 140. In this example, the locking mechanism 157 of the proximal hub 158 may contact and engage with the longitudinal body 142 of the inner tube 140, thereby fixing the position of the outer tube 250 and the expandable member 160 relative to the inner tube 140. Thus, the expandable member 160 can be maintained in the expanded state as long as the locking mechanism 157 remains engaged with the inner tube 140.

[0061] Although not shown, the inner tube 140 may include the multiple openings 143 shown and described above (Figures 2A to 2B) so that the porous body of the expandable member 160 can fluidly communicate with the lumen 141 of the inner tube 140 via the multiple openings 143. In this example, the expandable body 160 may be fluidly coupled to the collection container 136 and / or pressure regulator 132 via the lumen 141 of the inner tube 140. In other embodiments, the lumen 151 of the outer tube 250 may be fluidly coupled to the collection container 136 and / or pressure regulator 132. In this example, the openings 143 of the inner tube 140 may be completely omitted, and the expandable body 160 may be fluidly coupled to the collection container 136 and / or pressure regulator 132 via the lumens 151, 161.

[0062] Referring here to Figures 5 to 7B, another exemplary medical device 330 according to an example of the present disclosure is shown. Unless otherwise noted below, medical device 330 may be substantially similar to medical device 130 described above, and the same reference numerals are used to identify similar components. It should be understood that medical device 330 may be configured and operable in the same way as medical device 130, and that medical device 330 may be readily incorporated into the medical system 100 described above.

[0063] For example, referring first to Figures 5 and 7A, the medical device 330 may include a tube 240 having a longitudinal body 142 defined between a distal end 144 and a proximal end 146. The longitudinal body 142 of the tube 240 may include openings and / or slots 245 located on the longitudinal body 142, for example, along the middle of the outer wall of the longitudinal body 142, adjacent to the distal end 144. As will be shown and described in more detail herein, the slots 245 may be made to be of a size and shape that extends into the lumen 141 of the tube 240. In some embodiments, the slots 245 may include inclined surfaces for guiding one or more components of the medical device 330 from the lumen 141 of the tube 240 to the outer surface of the longitudinal body 142 and / or toward the distal end 144.

[0064] The tube 240 of the medical device 330 may further include an expandable member 160 positioned along the outer surface of the longitudinal body 142 and adjacent to the distal end 144. In this example, the expandable member 160 may be positioned around the longitudinal body 142 between the distal end 144 and the slot 245 of the tube 240. The medical device 330 may further include a thread 170 having a longitudinal body defined between the distal end 172 and the proximal end 174. The thread 170 may be positioned at least partially within the lumen 141 of the tube 240, and the distal portion of the thread 170 (e.g., including the distal end 172) may extend outward from the lumen 141 through the slot 245. In this example, the distal portion of the thread 170 may extend from the slot 245 toward the distal end 144 along the outer surface of the longitudinal body 142 of the tube 240.

[0065] Although not shown, in some embodiments, the tube 240 may include multiple channels located within the lumen 141 and isolated from others. In embodiments, at least one of the multichannels within the lumen 141 may be aligned with a slot 245 in the tube 240 and configured to receive the thread 170 therein. At least the other multichannels within the lumen 141 may be aligned with a number of openings 143 to fluidly connect to a pressure regulator 132 and / or a collection container 136. In this example, the slot 245 (and the thread 170 received therein) may be isolated from the vacuum generated within the tube 240 by the pressure regulator 132.

[0066] Referring further to Figures 5 and 7A, the expandable member 160 may be positioned around the distal end of the longitudinal body 142, with the thread 170 extending outward from the slot 245 toward the distal end 144, and the thread 170 may be configured to extend over the porous body of the expandable member 160. In this example, the longitudinal length of the thread 170 extends around the periphery of the expandable member 160, thereby forming one or more slip knots 176 (or connecting regions) positioned along the porous body of the expandable member 160. For example, the thread 170 may include a plurality of slip knots 176. The plurality of slip knots 176, when in a first position, enclose the expandable member 160 within them. The connecting regions may be portions of the thread 170 that are releasably or breakably bonded to the expandable member 160. For example, unless a destructive force is applied to the connection area, the connected areas of the thread 170 and the expandable member 160 may remain connected to each other (for example, while the expandable member 160 is moving).

[0067] Multiple slipknots 176 may be configured to apply force to the expandable member 160 in order to restrain the movement of the expandable member 160 relative to the tube 240. In other words, the thread 170 may be a restraining device, and the multiple slipknots 176 may be a restraining mechanism that is firmly coupled around the expandable member 160 in a restrained configuration so that the expandable member 160 is fixed to the longitudinal body 142. As described in more detail herein, the thread 170 may be configured such that when the multiple slipknots 176 are released into a slack configuration, the expandable member 160 may transition from a compressed state to an expanded state (Figures 6 and 7B).

[0068] Referring to Figure 6, the medical device 330 is schematically shown with the longitudinal body 142 of the tube 240 omitted for clarity. As shown herein, the multiple slipknots 176 extend around the longitudinal length of the expandable member 160 and terminate at the most distal slipknot 176 adjacent to the distal end 172 of the thread 170. Furthermore, the proximal end 174 of the thread 170 may include a linear configuration that can be grasped by hand or mechanically by the user of the medical system 100. Thus, when the proximal end 174 of the thread 170 is actuated (for example by applying a tensile force proximal), the thread 170 moves proximal (for example from a first position to a second position), and one or more of the multiple slipknots 176 may transition / break from a constrained configuration (Figure 5) to a relaxed configuration (Figure 6). In this example, the expandable member 160 can expand laterally outward in the expanded state.

[0069] Referring now to Figure 7B, in some embodiments, the thread 170 may be configured such that the actuation of its proximal end 174 (for example, to a second position) can remove one or more of the slipknots 176. In this example, the nearest slipknot 176 of the thread 170 can be released from around the expandable member 160, thereby removing the restraining force applied to the expandable member 160. By removing the restraining force on the expandable member 160 with the thread 170, the porous material of the expandable member 160 may be allowed to expand laterally outward relative to the longitudinal body 142 of the tube 240.

[0070] It should be understood that if one or more of the slipknots 176 are maintained along the porous body of the expandable member 160, the rest of the expandable member 160 (e.g., distal length) may remain compressed despite the action of the thread 170. In this example, the expandable member 160 may be at least partially expanded and at least partially compressed. The expandable member 160 may transition to a fully expanded state in response to the removal of all and / or substantially all of the slipknots 176 of the thread 170 along the outside of the expandable member 160. The rupture of each individual slipknot 176 may provide the user of the medical device 330 with tactile feedback regarding the degree of expansion of the expandable member 160.

[0071] Each of the aforementioned systems, apparatus, assemblies, and methods may be used to provide controlled treatment of a targeted treatment site by intraluminal vacuum therapy. Any of the medical devices 130, 230, and 330 described above, for example, any of the tubes 140, 150, 240, and 250 and expandable members 160 of medical devices 130, 230, and 330, may be inserted into an endoscope (e.g., medical device 110) or similar apparatus having an imaging system, illumination system, etc., to assist in the positioning of medical devices 130, 230, and 330. By providing an apparatus that enables the user to treat hard-to-reach tissues using an expandable member 160 that applies negative pressure through a vacuum-sealed sponge, the user can reduce overall procedure time, increase the efficiency and effectiveness of the procedure, and avoid unnecessary harm to the subject's body resulting from unhealed wounds.

[0072] (Note) As a preferred embodiment, the technical concept that can be understood from the above embodiment is described below. [Item 1] It is a medical device, The medical device comprises a shaft defining a lumen and a distal portion, the distal portion defining a side opening that fluidly communicates with the lumen, The medical device comprises a device that is coupled to the distal portion of the shaft and covers the side opening, and the device is An expandable member configured to expand laterally outward from a compressed state to an expanded state, and configured to allow fluid to pass through and flow into the side opening, A restraining device is positioned in contact with the expandable member and configured to move from a first position to a second position relative to the expandable member. Includes, The expandable member is in the compressed state when the restraint device is in the first position, and the expandable member is in the expanded state when the restraint device is in the second position. The restraint device includes an inner tube positioned within the lumen of the shaft, and a distal tip extending distally to the distal end of the shaft. A medical device in which the proximal portion of the distal tip is coupled to the distal portion of the expandable member. [Item 2] The medical device according to item 1, wherein when a proximal force is applied to the inner tube, the expandable member shortens in the longitudinal direction and expands laterally outward. [Item 3] It is a medical device, The medical device comprises a shaft defining a lumen and a distal portion, the distal portion defining a side opening that fluidly communicates with the lumen, The medical device comprises a device that is coupled to the distal portion of the shaft and covers the side opening, and the device is An expandable member configured to expand laterally outward from a compressed state to an expanded state, and configured to allow fluid to pass through and flow into the side opening, A restraining device is positioned in contact with the expandable member and configured to move from a first position to a second position relative to the expandable member. Includes, The expandable member is in the compressed state when the restraint device is in the first position, and the expandable member is in the expanded state when the restraint device is in the second position. The shaft includes a slot, the slot is close to the distal portion of the shaft and extends toward the lumen of the shaft, A medical device comprising a restraint device including a thread extending outward from the lumen of the shaft through the slot, the thread being attached to the distal portion. [Item 4] The medical device according to item 3, wherein the proximal portion of the thread extends into the lumen, and the distal portion of the thread is positioned to overlap the outer surface of the distal portion of the shaft and extends around the expandable member. [Item 5] The distal portion of the thread includes one or more knots that connect the thread to the expandable member. The medical device according to item 4, wherein the one or more knots are configured to break or unravel in response to a force applied to the threads proximal to them. [Item 6] The medical device according to any one of items 1 to 5, further comprising a locking mechanism configured to fix the restraint device to the expandable member, thereby maintaining the restraint device in at least one of the first or second positions, and maintaining the expandable member in at least one of the expanded or compressed state. [Item 7] The medical device according to any one of items 1 to 6, further comprising a pressure source in fluid communication with the lumen, wherein the pressure source is configured to generate suction at the distal end of the shaft through the side opening such that fluid located adjacent to the distal end is drawn into the lumen through the expandable member. [Item 8] The medical device according to any one of items 1 to 7, wherein the expandable member includes a porous body containing a plurality of fibers. [Item 9] The medical device according to any one of items 1 to 8, wherein the expandable member has a larger diameter in the expanded state than in the compressed state. [Item 10] The medical device according to any one of items 1 to 9, wherein the side opening is one of a plurality of side openings extending into the shaft. [Item 11] The medical device according to any one of items 1 to 10, wherein the expandable member is fixed to the shaft along the entire length of the expandable member. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus and methods without departing from the scope of this disclosure. The disclosed apparatus should be understood to include various suitable computer systems and / or computing units incorporating multiple hardware components, such as a processor and a non-temporary computer-readable medium, which enable the apparatus to perform one or more operations during procedures described herein. Other aspects of this disclosure will be apparent to those skilled in the art from this specification and consideration of the techniques of the features disclosed herein. This specification and examples are intended to be illustrative only.

Claims

1. It is a medical device, The medical device comprises a longitudinal body extending from the proximal end to the distal end, and the longitudinal body is A lumen extending from the proximal end to the distal end, Distended at the distal end of the longitudinal body, one or more openings communicating with the lumen Equipped with, The medical device comprises an expandable member positioned around the distal portion of the longitudinal body, the expandable member communicating with the lumen through one or more openings, The medical device comprises a thread, the distal portion of which extends around the expandable member, and the thread is movable relative to the expandable member so as to move the expandable member from a contracted state to an expanded state. A medical device in which the proximal portion of the thread extends through the lumen.

2. A medical device, The medical device comprises a longitudinal body extending from the proximal end to the distal end, and the longitudinal body is A lumen extending from the proximal end to the distal end, Distended at the distal end of the longitudinal body, one or more openings communicating with the lumen Equipped with, The medical device comprises an expandable member positioned around the distal portion of the longitudinal body, the expandable member communicating with the lumen through one or more openings, The medical device comprises a thread, the distal portion of which extends around the expandable member, and the thread is movable relative to the expandable member so as to move the expandable member from a contracted state to an expanded state. The longitudinal body is provided with a slot, and the expandable member is positioned between the slot and the distal end of the longitudinal body. A medical device in which the distal portion of the thread extends outward from the lumen through the slot.

3. A medical device, The medical device comprises a longitudinal body extending from the proximal end to the distal end, and the longitudinal body is A lumen extending from the proximal end to the distal end, Distended at the distal end of the longitudinal body, one or more openings communicating with the lumen Equipped with, The medical device comprises an expandable member positioned around the distal portion of the longitudinal body, the expandable member communicating with the lumen through one or more openings, The medical device comprises a thread, the distal portion of which extends around the expandable member, and the thread is movable relative to the expandable member so as to move the expandable member from a contracted state to an expanded state. A medical device comprising a plurality of knots connected to the expandable member at the distal end of the thread.

4. A medical device, The medical device comprises a longitudinal body extending from the proximal end to the distal end, and the longitudinal body is A lumen extending from the proximal end to the distal end, Distended at the distal end of the longitudinal body, one or more openings communicating with the lumen Equipped with, The medical device comprises an expandable member positioned around the distal portion of the longitudinal body, the expandable member communicating with the lumen through one or more openings, The medical device comprises a thread, the distal portion of which extends around the expandable member, and the thread is movable relative to the expandable member so as to move the expandable member from a contracted state to an expanded state. A medical device wherein the lumen is a first lumen, the longitudinal body further comprises a second lumen, the first lumen is configured to be coupled to a pressure source, and the proximal portion of the thread extends through the second lumen.

5. The medical device according to any one of claims 1, 3, and 4, wherein the longitudinal body is provided with a slot, and the expandable member is disposed between the slot and the distal end of the longitudinal body.

6. The medical device according to claim 5, wherein the distal portion of the thread extends outward from the lumen through the slot.

7. The medical device according to any one of claims 2, 5, and 6, wherein the slot has an inclined surface.

8. The medical device according to claim 3, wherein each of the plurality of knots is configured to be released from the expandable member when a proximal force is applied to the thread.

9. The medical device according to claim 3 or 8, wherein each of the plurality of knots is configured to transition from a restraining configuration to a relaxation configuration.

10. The medical device according to any one of claims 3, 8, and 9, wherein each of the plurality of knots is a slipknot.

11. The medical device according to any one of claims 3 and 8 to 10, wherein the most distal knot among the plurality of knots is adjacent to the distal end of the thread.

12. The medical device according to any one of claims 1 to 11, wherein the expandable member is fixed to the longitudinal body along the entire length of the expandable member in both the contracted state and the expanded state.

13. The medical device according to any one of claims 1 to 12, wherein the expandable member includes a porous body.

14. The medical device according to any one of claims 1 to 13, further comprising a hub located at the proximal end of the longitudinal body, wherein the hub is coupled to a pressure source and configured to generate suction through the lumen.

15. The medical device according to any one of claims 1 to 14, wherein the distal end of the longitudinal body is closed.

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