Medical therapy system and method 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 devices, and related methods. Examples of the present disclosure relate, among other things, to systems, devices, and related methods for removing substances from a target site within a patient by generating a negative pressure within the target site within the patient.

Background Art

[0002] Endoscopic and open surgical procedures of the gastrointestinal (GI) tract include, for example, among other things, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These procedures can cause perforations, postoperative leaks, or other injuries to the tube. There are only limited treatment options for the management of such injuries, and morbidity and mortality are significant. Options include surgical reoperation and endoscopic placement of stents or clips. Surgery is relatively invasive and has high morbidity and mortality. Endoscopic stent placement is a less invasive option. However, the placed stent can move from the intended position and / or encapsulate an infection at the treatment site, inhibiting drainage.

Summary of the Invention

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

[0004] According to one example, a medical device includes a shaft defining a lumen and a distal portion. The shaft has a side opening in the distal portion that is in fluid communication 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 to allow fluid to pass through the expandable member and flow into the side opening. The device includes a restraint device disposed 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 in a compressed state when the restraint device is in the first position and the expandable member is in an expanded state when the restraint device is in the second position.

[0005] Any of the medical devices described in this specification may include one or more of the following features. The restraint device includes an outer tube disposed over the shaft, and the expandable member is surrounded between the shaft and the outer tube when the outer tube is in the 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 the second position. The restraint device includes an inner tube disposed within the lumen of the shaft and a distal tip extending distally beyond the distal end of the shaft. The proximal portion of the distal tip is coupled to the distal portion of the expandable member. By applying a proximal force to the inner tube, the expandable member shortens longitudinally and expands laterally outward. The shaft includes a slot that is proximate to the distal portion 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, and the thread is attached to the distal portion. The proximal portion of the thread extends into the lumen, and the distal portion of the thread is disposed 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 that couple the thread to the expandable member. The one or more knots are configured to break or loosen in response to a proximal force being applied to the thread. The restraint device further includes a locking mechanism that fixes the restraint device to the expandable member, thereby maintaining the restraint device in at least one of the first position or the second position and maintaining the expandable member in at least one of the expanded state or the compressed state. The restraint device further includes a pressure source 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 such that fluid adjacent to the distal portion is drawn through the expandable member into the lumen. The expandable member includes a porous body including 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 the entire length of the expandable member.

[0006] According to another example, a medical device includes a shaft that defines a lumen along a longitudinal axis, the shaft including at least one opening within an outer surface of the shaft. The at least one opening is in fluid communication with the lumen. The medical device includes a porous body disposed over 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 restraint member engaged with and movable relative to the porous body, the restraint member being configured to apply a binding force to the porous body. After the restraint member transitions 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 of the medical devices described herein may include one or more of the following features. The porous body has a smaller cross-sectional diameter around the longitudinal axis in the compressed state than in the expanded state. The porous body is a sponge having a porosity that allows passage of fluid within the porous body.

[0008] According to another example, a method of withdrawing fluid by a medical device, the medical device including a shaft, an expandable porous body disposed along the shaft, and a restraint device in contact with the expandable porous body, the method including moving the restraint device relative to the expandable porous body to enable expansion of the expandable porous body around the shaft. The method includes applying suction through the shaft and withdrawing fluid into the shaft through the expandable porous body and through one or more openings disposed between the expandable porous body and the shaft.

[0009] It is to be understood that both the foregoing summary and the following detailed description of the invention are merely illustrative and explanatory and are not restrictive of the claimed invention. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the disclosure and, together with the description, serve to explain the principles of the disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0010]

Figure 1

Figure 2A

Figure 2B

Figure 3

Figure 4A

Figure 4B

Figure 5

Figure 6

Figure 7A

Figure 7B

DETAILED DESCRIPTION OF THE INVENTION

[0011] Endoluminal vacuum therapy (EVAC) has been proposed. In EVAC, for example, negative pressure is delivered to a wound site within the gastrointestinal tract through a nasogastric tube having a sponge at its distal end. The sponge is endoscopically placed over a perforation, leak, 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, devices, and methods for removing substances from a target site within a subject (e.g., a patient) by generating negative pressure within the target site within the subject. Embodiments of the present disclosure include devices, systems, and methods for endoluminal vacuum therapy (EVAC). In this example, EVAC includes the intraluminal placement of a porous body, such as a sponge or other similar material, over a wound site including a perforation, cyst, leak, anastomosis, etc. The placement of the material can be via a catheter, scope (endoscope, bronchoscope, colonoscope, etc.), tube, or sheath inserted into the gastrointestinal tract through a natural orifice. The orifice can be, for example, the nose, mouth, or anus, and the placement can be within any portion of the gastrointestinal tract including the esophagus, stomach, duodenum, large intestine, or small intestine. The placement can also be within other organs accessible via the gastrointestinal tract.

[0013] Here, aspects of the present disclosure are referred to in detail, and examples thereof are shown in the accompanying drawings. Throughout the drawings, the same or similar reference numerals are used to refer to the same or similar parts, as far as possible. The term "distal" refers to the part that is farthest from the user when introducing the device into the patient. In contrast, the term "proximal" refers to the part that is closest to the user when positioning the device on the subject. As 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 that includes a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or device. The term "exemplary" is used in the sense of "an example" rather than "ideal". As used herein, the terms "about", "substantially", and "approximately" indicate a range of values within + / - 10% of the recited value.

[0014] Examples of the present disclosure can be used to treat a target site where leakage has occurred by negative pressure wound therapy. For example, some embodiments may combine a delivery tube with a porous body and / or an absorption device to remove any substance (e.g., fluid, mass, etc.) from the target site and dry the surrounding tissue of any leakage. The porous body and / or the absorption device may be disposed 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 the absorption device may be selectively expandable between a compressed default state and an expanded operating state. Further, the porous body and / or the absorption device may be constrained in the compressed default state by one or more other components including, for example, an outer sheath disposed on the absorption device, a length of the delivery tube, and / or a restraint device coupled to the porous body and / or the absorption device. The porous device and / or the absorption device may be configured to remove substances 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 for treating the large intestine (colon), small intestine, cecum, a portion of the esophagus, any other part of the gastrointestinal tract, and / or any other suitable patient anatomical structure (collectively referred to herein as the "target treatment site"). The various examples described herein include single-use or disposable medical devices. Now, refer in detail to the examples of the present disclosure shown in the above and the accompanying drawings. As much as possible, the same reference numbers are used throughout the drawings to refer to the same or similar components.

[0016] FIG. 1 shows a schematic view 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, relative to a subject (e.g., a patient). In an embodiment, the medical instrument 110 may be any type of endoscope, duodenoscope, gastroscope, colonoscope, ureteroscope, bronchoscope, catheter, or other delivery system, and may include a handle 112, an actuation 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 communicates with one or more lumens of the handle 112. As described in more detail herein, the at least one port 116 is sized and shaped to receive one or more instruments, such as the medical device 130 of the medical system 100, therein.

[0017] The shaft 120 of the medical device 110 may include a tube. The tube has sufficient flexibility, and the shaft 120 is configured to selectively bend, rotate, and / or twist when inserted into and / or passing through the tortuous anatomical structure of the subject to reach the target treatment site. The shaft 120 may have one or more lumens (not shown) extending therethrough. The 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 actuating one or more distal components / tools (e.g., articulating joints, dissectors, etc.), a fluid lumen for delivering fluid, a lighting lumen for receiving at least a portion of a lighting assembly (not shown), and / or an imaging lumen for receiving at least a portion of an imaging assembly (not shown).

[0018] Referring further to FIG. 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 that communicate with one or more lumens of the shaft 120. For example, the tip 122 may include a working opening, and the medical device 130 may be able to exit the working lumen of the shaft 120 through the working opening.

[0019] In other examples, the tip 122 of the shaft 120 can include additional and / or fewer openings. The openings can be, for example, fluid openings or nozzles that can discharge fluid from the fluid lumen of the shaft 120, illumination openings / windows from 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 can 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., by actuation of control wires), delivery of fluid, emission of illumination, and / or various imaging functions.

[0020] With further reference to FIG. 1, the medical device 130 of the medical system 100 can 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 being disposed within 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 can be twice the length of the longitudinal body 152 of the outer tube 150, although other relative lengths are 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 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 to 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 be sized, shaped, and configured to define a cavity sized to receive one or more substances from the medical device 130. As described in more detail herein, the collection container 136 may be configured to store substances removed at the distal end 144 by the medical device 130.

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

[0024] The medical instrument 110 is configured to receive a medical device 130 that passes through the shaft 120 via a working lumen and reaches the working opening of the tip 122 via at least one port 116. In this example, as described in more detail below, the medical device 130 can extend distally from the working opening of the tip 122 and can extend into an external environment surrounding the tip 122, such as, for example, a target treatment site of a subject. The outer tube 150 can extend distally from the working opening of the tip 122 in response to movement of the longitudinal body 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 disposed within the lumen of the outer tube 150 such that it can extend distally from the working aperture of the chip 122 together with the outer tube 150 in response to movement of the medical device 130 through the working lumen of the shaft 120 (i.e., tubes 140, 150 can move simultaneously). In this example, it should be understood that the inner tube 140 can be disposed within the lumen of the outer tube 150 such that the distal end 144 of the inner tube 140 is disposed proximally relative to the distal end 154 of the outer tube 150.

[0026] Referring further to FIG. 1, the medical device 130 can further include an apparatus at the distal end 144 of the inner tube 140. In this example, the apparatus of the medical device 130 can include an expandable member 160. The expandable member 160 can be disposed at the distal end 144 of the inner tube 140 and / or can extend distally relative to the distal end 144 of the inner tube 140. In some embodiments, the expandable member 160 can include an absorbent device coupled to the distal end 144 of the inner tube 140. In this example, the expandable member 160 can be disposed along the sidewall and / or outer surface of the longitudinal body 142 of the inner tube 140.

[0027] In other embodiments, it should be understood that the expandable member 160 can be disposed along various other surfaces of the inner tube 140 and / or portions of the medical device 130 without departing from the scope of the present disclosure. Most or all of the expandable member 160 can be disposed proximally to the most distal portion 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 can extend distally relative to the distal end 144 of the inner tube 140.

[0028] Referring now to FIG. 2A, the expandable member 160 can include a porous body that includes a plurality of flexible and / or compressible fibers. In embodiments of the present disclosure, the porous body can include a sponge and / or a foam. The sponge and / or foam can be any suitable biocompatible material capable of absorbing and / or passing a liquid by a negative pressure, such as from a pressure regulator 132 of the medical system 100. The material of the porous body (e.g., the plurality of fibers) of the expandable member 160 can be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. Further, the sponge material of the porous body can be an open-cell foam. Suitable materials can 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 can define a mesh formed by a plurality of fibers. In this example, the expandable member 160 can be configured and operable to selectively expand. In other words, the volume capacity of the expandable member 160 can be selectively adjusted. By the expandable member 160 forming a sponge and / or a foam, it should be understood that the expandable member 160 can be configured to pass and / or deliver one or more substances (e.g., fluids) through the porous body of the expandable member 160.

[0030] Referring further to FIG. 2A, as described above, the medical device 130 includes one or more hubs 148, 158 (e.g., handles) for manually gripping and actuating the tubes 140, 150. In this example, the inner tube 140 may include a proximal hub 148 at and / or in the vicinity of 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 in the vicinity of 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 a luer 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 removable 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 removably coupled to the proximal end 146 of the longitudinal body 142 such that the proximal hub 148 is 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 that extends 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 fluidly coupled to the collection container 136 and the pressure regulator 132 via the proximal hub 148 such 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 therein. In other words, in some embodiments, fluid cannot be carried through the distal end 144. However, in other embodiments, it is contemplated that the distal end 144 of the inner tube 140 may be open, thereby allowing fluid to be carried through the distal end 144.

[0032] Furthermore, the longitudinal body 152 of the outer tube 150 may define a lumen 151 that extends 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, shaped, and configured to slidably receive the longitudinal body 142 of the inner tube 140 and form an opening of such size, shape, and configuration. In this example, the inner tube 140 may be received within the lumen 151 of the outer tube 150 through an opening at the proximal end 156 and may extend distally and / or outwardly from the lumen 151 through an opening at the distal end 154 of the outer tube 150.

[0033] With further reference to FIG. 2A, the inner tube 140 of the medical device 130 may further include one or more openings 143. The openings 143 are disposed along the outer wall of the longitudinal body 142 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 where the expandable member 160 is located in the longitudinal direction. The plurality of openings 143 may extend through the longitudinal body 142 and into the lumen 141 of the inner tube 140. It should be understood that by disposing the expandable member 160 along the outside of the longitudinal body 142 and positioning it over the plurality of openings 143, the porous body of the expandable member 160 may be in fluid communication with the lumen 141 of the inner tube 140 through the plurality of openings 143. The openings 143 may include various suitable sizes, shapes, and / or configurations. In some embodiments, the openings 143 of the inner tube 140 may be micron-sized (e.g., micrometers), although other suitable dimensions are also contemplated (e.g., millimeters, centimeters, etc.).

[0034] By arranging the inner tube 140 within the lumen 151 of the outer tube 150, it should be understood that the inner surface of the longitudinal body 152 can be operable to constrain the size, shape, profile, and / or configuration of the expandable member 160. In other words, the outer tube 150 can be a constraining device configured to contact and / or engage the expandable member 160, thereby compressing the porous body of the expandable member 160 into a compressed state. As shown and described in more detail herein, the medical device 130 can stop the constraining / confining force applied to the expandable member 160 by the longitudinal body 152 by removing the outer tube 150 covering the expandable member 160, and can be configured to allow the porous body of the expandable member 160 to expand outwardly (FIG. 2B) into its resting / biased state.

[0035] Referring now to FIG. 2B, an inner tube 140 with the proximal hub 148 omitted from the proximal end 146 is schematically shown. As briefly described above, the proximal hub 148 can be a removable luer and / or hub such that the proximal hub 148 can be configured to separate from the longitudinal body 142. In this example, removal of the proximal hub 148 from the longitudinal body 142 can allow proximal movement of the outer tube 150 relative to the inner tube 140. It should be understood that including the proximal hub 148 along the proximal end 146 of the longitudinal body 142 can prevent proximal movement of the outer tube 150 beyond the proximal end 146 of the inner tube 140 due to the presence of the proximal hub 148 on the proximal end 146 of the longitudinal body 142. In other words, when the outer tube 150 moves proximally, the proximal hub 148 of the inner tube 140 can engage and / or abut against the proximal hub 158 of the outer tube 150, thereby fixing (and effectively functioning as a stop) the outer tube 150 to the inner tube 140.

[0036] When 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 proximally to such an extent that the expandable member 160 can extend outwardly from the lumen 151 of the longitudinal body 152. In this example, the restraining force applied to the expandable body 160 by the outer tube 150 is removed, thereby enabling the expandable body 160 to expand radially, proximally, and / or distally outwardly relative to the inner tube 140. The expandable body 160 can extend laterally outwardly relative to and around the longitudinal body 142 such that it has a larger diameter when in the expanded state than when the expandable body 160 is in the compressed state (FIG. 2A).

[0037] With further reference to FIG. 2B, it should be understood that when the expandable body 160 is in the expanded state, the expandable body 160 can remain fixed to the longitudinal body 142 of the inner tube 140. In this example, when transitioning from the compressed state (FIG. 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 plurality of openings 143. Thus, when extended to the expanded state, the porous body of the expandable member 160 can remain in fluid communication with the lumen 141 of the inner tube 140 through the plurality of openings 143. As described in more detail herein, when the expandable member 160 is in the expanded state, the plurality of openings 143 are configured and operable to remove one or more substances (e.g., solids, fluids, etc.) inside or outside the porous body, or to allow one or more substances (e.g., solids, fluids, etc.) 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 now to FIG. 3, an exemplary method of using a medical system 100 to treat a target site within a subject 10 (e.g., a patient) is schematically illustrated. For example, the shaft 120 of the medical instrument 100 can 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 body natural orifice) of the subject's body 10. In an embodiment, the medical instrument 110 can 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. It should be understood that the length of the shaft 120 can be sufficient such that while the tip 122 of the medical instrument 110 is inside the subject's body 10, the proximal end (including the handle 112) of the medical instrument 110 is outside the subject's body 10.

[0039] In this example, the target treatment site 22 within the subject's body 10 can be located along the gastrointestinal tract within the esophagus 16. The target treatment site 22 can include, for example, an anastomotic leak or perforation in 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.). Although the present 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 the present 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 can be adjusted (e.g., manually arranged) by the user before implanting the medical device 130 into the subject 10.

[0040] Referring further to FIG. 3, the shaft 120 of the medical instrument 110 can be extended into the body 10 of the subject until the tip 122 of the shaft 120 reaches a position in the vicinity of 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) can be received into the medical instrument 100 through the port 116, for example, within the shaft 120, before and / or after inserting the medical instrument 110 into the body 10 of the subject. With the tip 122 of the shaft 120 disposed adjacent to the target treatment site 22 and the medical device 130 disposed within the target treatment site 22, the medical device 130 can be actuated (e.g., at the proximal hubs 148, 158) to extend the outer tube 150 and / or the inner tube 140 distally from the tip 122 of the shaft 120. In this example, the distal end 154 of the outer tube 150 extends outwardly from the lumen of the shaft 120.

[0041] With the outer tube 150 disposed within the esophagus 16 (or gastrointestinal tract) and adjacent to the target treatment site 22, the user can actuate one or more components of the medical instrument 110 and / or the medical device 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 (FIGS. 2A-2B) of the medical device 140 can be actuated to articulate (e.g., change direction, curve, rock, etc.) the distal end 154 of the outer tube 150 relative to the tip 122 of the shaft 120. In this example, the distal portion of the outer tube 150 (and the inner tube 140 received within the outer tube 150) can be moved into the perforation of the target treatment site 22 with the remaining portions of the longitudinal bodies 142, 152 of the tubes 140, 150 disposed external to the target treatment site 22. In this example, it should be understood that the expandable body 160 of the medical device 130 can be disposed within the target treatment site 22 in a contracted and / or compressed state (FIG. 2A). Alternatively, the distal end 154 of the outer tube 150 can be disposed adjacent to the target treatment site 22 and retracted to expand the expandable member 160. In this example, the expandable member 160 can be moved within the target treatment site 22.

[0042] Referring further to FIG. 3, when the medical device 130 is disposed at the target treatment site 22, the shaft 120 of the medical instrument 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 disposed within the target treatment site 22 (e.g., anastomotic leakage or perforation), the proximal ends 146, 156 of the tubes 140, 150 can be disposed outside the subject's body 10. In this example, the proximal hubs 148, 158 of the tubes 140, 150 can be accessible to the user of the medical system 100. For example, the proximal hub 148 of the inner tube 140 can be removed from the proximal end 146 of the longitudinal body 142 to facilitate removal of the outer tube 150 that covers the inner tube 140.

[0043] In some embodiments, during insertion of the inner tube 140 into the esophagus 16 (gastrointestinal tract), the inner tube 140 may not be coupled to the pressure regulator 132. In this example, after removal of the proximal hub 148, a different hub can 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 can be reattached to the proximal end 146 and configured to fluidly couple the inner tube 140 to the pressure regulator 132. In some embodiments, removal of the proximal hub 148 from the proximal end 146 of the longitudinal body 142 can separate 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 such that the expandable member 160 extends distally from the distal end 154 of the longitudinal body 152.

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

[0045] Referring again to FIG. 2B, with the expandable member 160 in the expanded state and the distal end 144 of the longitudinal body 142 disposed within the target treatment site 22, the porous body of the expandable member 160 can contact the surrounding tissue defining the target treatment site 22 or, alternatively, can be disposed within the target treatment site 22. In this example, the expandable member 160 can be configured to absorb one or more substances (e.g., fluid, solid, etc.) within the target treatment site 22. For example, the porous body of the expandable member 160 can absorb fluid within the target treatment site 22, thereby drying the surrounding tissue defining the target treatment site 22. In some embodiments, the expandable member 160 can further be configured to alter (e.g., push, reposition, move, remove, displace, eliminate, etc.) the path of one or more substances within the target treatment site 22 when expanding outwardly to the expanded state.

[0046] Furthermore, the expandable member 160 can apply a force to and / or generate a pressure on any substance within and in 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 removed from over the inner tube 140 (and from the patient) so that the user of the medical system 100 can access the proximal end 146 of the longitudinal body 142. In this example, the proximal hub 148 (and / or another luer / hub connector) can 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 the pressure regulator 132 can be fluidly 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 can be configured and operable to convey one or more substances (e.g., fluids, bodily substances, etc.) from the target treatment site 22 to the collection container 136 (e.g., by suctioning, removing, pulling, withdrawing, etc.) via the expandable body 160 and the plurality of openings 143 in response to the operation of the pressure regulator 132. In this example, one or more substances within the target treatment site 22 can move around and / or through the porous body of the expandable member 160. In other words, a negative pressure is generated within the target treatment site 22 through the plurality of openings 143 by the pressure regulator 132.

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

[0049] Referring again to FIG. 1, with the proximal end 146 of the inner tube 140 being fluidly coupled to the collection container 136, substances and / or fluids 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 are arranged and / or configured such that when the collection container 136 stores one or more substances and / or fluids therein, the pressure regulator 132 can continue to generate a negative pressure into the lumen 141 of the inner tube 140 through the collection container 136.

[0050] For example, the connection port 134 connecting the collection container 136 and the pressure regulator 132 can be arranged along the upper portion of the collection container 136 so that fluid communication between the collection container 136 and the pressure regulator 132 is maintained when the lower portion of the collection container 136 receives substances and / or fluids therein. In other embodiments, the collection container 136 and the pressure regulator 132 are separated from each other and can be coupled to the proximal end 146 of the inner tube 140 through various other suitable configurations other than those shown and described herein. At the end of the procedure, the pressure regulator 132 can be deactivated, thereby stopping the suction within the target treatment site 22 through the inner tube 140.

[0051] Referring still further to FIG. 1, when the inner tube 140 is withdrawn through the esophagus 16 (gastrointestinal tract) (e.g., from the outside via the nose 12 and / or the mouth 14), accordingly, the porous body of the expandable member 160 can be adjusted (e.g., compressed) against, for example, the wall of the esophagus 16 when the inner tube 140 is being drawn into 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 (e.g., before withdrawal), thereby enclosing the expandable member 160 within the lumen 151 and facilitating removal of the medical device 130 from the subject 10.

[0052] Referring now to FIGS. 4A - 4B, another exemplary medical device 230 according to an example of the present disclosure is shown. Unless otherwise specifically described below, the medical device 230 may be substantially similar to the above - described medical device 130, and similar reference numerals are used to identify similar components. It should be understood that the medical device 230 is configured and operable like the medical device 130 and can be easily incorporated into the above - described medical system 100.

[0053] For example, referring first to FIG. 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 the 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 such 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 extension 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 may define a lumen 161 distal thereto.

[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 disposed 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 more detail herein, the locking mechanism 157 of the outer tube 250 may be configured and operable to engage the inner tube 140 of the medical device 230 to fix the longitudinal body 152 relative 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 FIG. 4A, the inner tube 140 of the medical device 230 can be disposed 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 can include a longitudinal body 142 defined between a distal end 145 and a proximal end 146. In this example, the distal end 145 extends distally relative to the distal end 154 of the outer tube 250 and the distal end of the expandable member 160. Further, the distal end 145 of the inner tube 140 can be sized and shaped to have a cross-sectional dimension that is larger than the cross-sectional dimensions of the lumen 151 and the lumen 161. The distal end of the expandable member 160 can be directly coupled and fixed to the distal end 145 of the inner tube 140.

[0056] In the example shown in FIG. 4A, the distal end 145 of the inner tube 140 can be disposed in the most distal extent (e.g., a first position) relative to the outer tube 250 such that the expandable member 160 is maintained in a compressed state. In this example, the longitudinal body of the expandable member 160 can be stretched between the distal ends 145, 154 of the tubes 140, 250. As further described herein, the expandable member 160 is configured to move relative to the outer tube 250 in response to 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 can be a restraint device configured to abut the distal end of the expandable member 160. In this example, the expandable member 160 can be operable to transition from a compressed state to an expanded state (FIG. 4B) in response to movement of the inner tube 140 relative to the outer tube 250 (e.g., to a second position). It should be understood that the porous body of the expandable member 160 can have a smaller profile, cross-sectional dimensions, diameter, etc., and a longer longitudinal length when in the compressed state than when in the expanded state.

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

[0059] It should be understood that the expandable body 160 can 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, 154. In other embodiments, the expandable body 160 can transition to the expanded state in response to the distal movement of the outer tube 250 relative to the inner tube 140.

[0060] Referring further to FIG. 4B, in the state where the expandable member 160 is in the expanded state, the proximal hub 158 of the outer tube 250 can be actuated to lock the outer tube 250 to the inner tube 140 so as to maintain the expandable member 160 in the expanded state. For example, applying a lateral (e.g., inward) force to the proximal hub 158 can cause the proximal hub 158 and / or the distal end 154 of the longitudinal body 152 to move relative to the inner tube 140. In this example, the locking mechanism 157 of the proximal hub 158 contacts and engages 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. Accordingly, the expandable member 160 can be maintained in the expanded state while the locking mechanism 157 remains engaged with the inner tube 140.

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

[0062] Referring now to FIGS. 5-7B, another exemplary medical device 330 according to an example of the present disclosure is shown. Unless otherwise described below, the medical device 330 may be substantially similar to the medical device 130 described above, and like reference numbers are used to identify like components. It should be understood that the medical device 330 may be configured and operable like the medical device 130 and can be easily incorporated into the medical system 100 described above.

[0063] For example, initially referring to FIGS. 5 and 7A, the medical device 330 can 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 can include an opening and / or slot 245 disposed on the longitudinal body 142, such as adjacent to the distal end 144, for example, along an intermediate portion of the outer wall of the longitudinal body 142. As shown and described in more detail herein, the slot 245 can be sized and shaped to extend into the lumen 141 of the tube 240. In some embodiments, the slot 245 can include an inclined surface 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 towards the distal end 144.

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

[0065] Although not shown, in some embodiments, it should be understood that tube 240 may be disposed within lumen 141 and include a plurality of channels separated from others. In an embodiment, at least one of the multi-channels within lumen 141 may be aligned with slot 245 of tube 240 and configured to receive thread 170 therein. At least the other of the multi-channels within lumen 141 may be aligned with a plurality of openings 143 to fluidly couple a pressure regulator 132 and / or a collection container 136 thereto. In this example, slot 245 (and thread 170 received therein) may be isolated from the vacuum generated within tube 240 by pressure regulator 132.

[0066] With further reference to FIGS. 5 and 7A, an expandable member 160 is disposed around a distal portion of the longitudinal body 142, and with thread 170 extending outwardly from slot 245 toward distal end 144, thread 170 may be configured to extend over a porous body of expandable member 160. In this example, the longitudinal length of thread 170 extends around the perimeter of expandable member 160, thereby forming one or more slip knots (or connection regions) 176 disposed along the porous body of expandable member 160. For example, thread 170 may include a plurality of slip knots 176. The plurality of slip knots 176 enclose expandable member 160 within them when in a first position. The connection region may be a portion of thread 170 releasably or destructibly coupled to expandable member 160. For example, the connected region of thread 170 and expandable member 160 may remain coupled to each other without applying a breaking force to the connection region (e.g., during movement of expandable member 160).

[0067] The plurality of slip knots 176 can be configured to apply a force to the expandable member 160 to restrain movement of the expandable member 160 relative to the tube 240. In other words, the thread 170 can be a restraining device, and the plurality of slip knots 176 can be a restraining mechanism that is firmly coupled around the expandable member 160 in a restraining configuration such that the expandable member 160 is fixed relative to the longitudinal body 142. As described in more detail herein, the thread 170 can be configured such that when the plurality of slip knots 176 are released into a relaxed configuration, the expandable member 160 can transition from a compressed state to an expanded state (FIGS. 6 and 7B).

[0068] Referring to FIG. 6, the medical device 330 is shown schematically with the longitudinal body 142 of the tube 240 omitted for clarity. As shown herein, the plurality of slip knots 176 extend around the longitudinal length of the expandable member 160 and terminate at the most distal slip knot 176 adjacent the distal end 172 of the thread 170. Further, the proximal end 174 of the thread 170 can include a straight configuration that can be grasped by hand or mechanically by a user of the medical system 100. Thus, actuating the proximal end 174 of the thread 170 (e.g., by applying a proximal tensile force) causes the thread 170 to move proximally (e.g., from a first position to a second position) and one or more of the plurality of slip knots 176 can transition / fail from a restraining configuration (FIG. 5) to a relaxed configuration (FIG. 6). In this example, the expandable member 160 can expand laterally outward in an expanded state.

[0069] Referring now to FIG. 7B, in some embodiments, the thread 170 can be configured such that actuation of the proximal end 174 (e.g., to a second position) can cause removal of one or more of the plurality of slip knots 176. In this example, the most proximal slip knot 176 of the thread 170 is untied from around the expandable member 160, thereby removing the restraining force applied to the expandable member 160. Removing the restraining force applied to the expandable member 160 by the thread 170 can enable the porous body of the expandable member 160 to expand laterally outward relative to the longitudinal body 142 of the tube 240.

[0070] If one or more of the plurality of slip knots 176 are maintained along the porous body of the expandable member 160, it should be understood that the remaining portion (e.g., distal length) of the expandable member 160 may remain in a compressed state despite the actuation of the thread 170. In this example, the expandable member 160 can be at least partially expanded and at least partially compressed. The expandable member 160 can transition to a fully expanded state in response to the removal of all and / or substantially all of the plurality of slip knots 176 of the thread 170 along the outside of the expandable member 160. The breakage of each individual slip knot 176 can 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 foregoing systems, devices, assemblies, and methods can be used to provide controlled treatment of a target treatment site by intraluminal vacuum therapy. Any of the medical devices 130, 230, 330 described and recited above, e.g., any of the tubes 140, 150, 240, 250 and the expandable member 160 of the medical devices 130, 230, 330, can be inserted into an endoscope (e.g., medical instrument 110) or a similar device having an imaging system, a lighting system, etc. to assist in the positioning of the medical devices 130, 230, 330. By providing a device that enables the user to treat difficult-to-reach tissues using an expandable member 160 that applies negative pressure via a vacuum-sealed sponge, the user can reduce the overall treatment time, increase the efficiency and effectiveness of the treatment, and avoid unnecessary harm to the subject's body caused by unhealed wounds.

[0072] (Appendix) As a preferred embodiment, the technical idea that can be grasped from the above embodiments is described below. [Item 1] A medical device, The medical device includes a shaft defining a lumen and a distal portion, and the distal portion defines a side opening in fluid communication with the lumen. The medical device includes a device that is coupled to the distal portion of the shaft and covers the side opening, and the device includes an expandable member configured to expand laterally outward from a compressed state to an expanded state, through which fluid passes and which is configured to allow fluid to flow into the side opening, and a restraint device disposed in contact with the expandable member and configured to move from a first position to a second position relative to the expandable member and 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 disposed within the lumen of the shaft and includes a distal tip extending distally beyond the distal end of the shaft, a medical device, wherein a proximal portion of the distal tip is coupled to a 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] A medical device, the medical device includes a shaft defining a lumen and a distal portion, the distal portion defining a side opening in fluid communication with the lumen, the medical device includes a device that is coupled to the distal portion of the shaft and covers the side opening, and the device includes an expandable member configured to expand laterally outward from a compressed state to an expanded state, through which fluid passes and which is configured to allow fluid to flow into the side opening, and a restraint device disposed in contact with the expandable member and configured to move from a first position to a second position relative to the expandable member and 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 that is adjacent to the distal portion of the shaft and extends into the lumen of the shaft. The restraint device includes a thread that extends outward from the lumen of the shaft through the slot, and the thread is attached to the distal portion. Medical device. [Item 4] The proximal portion of the thread extends into the lumen, and the distal portion of the thread is disposed covering the outer surface of the distal portion of the shaft and extends around the expandable member. The medical device according to item 3. [Item 5] The distal portion of the thread includes one or more knots that couple the thread to the expandable member. The one or more knots are configured to break or come loose in response to a proximal force being applied to the thread. The medical device according to item 4. [Item 6] Further includes a locking mechanism that fixes the restraint device to the expandable member, thereby maintaining the restraint device in at least one of the first position or the second position, and maintaining the expandable member in at least one of the expanded state or the compressed state. The medical device according to any one of items 1 to 5. [Item 7] Further includes a pressure source in fluid communication with the lumen, and the pressure source is configured to generate suction at the distal portion of the shaft through the side opening so that fluid adjacent to the distal portion is drawn into the lumen through the expandable member. The medical device according to any one of items 1 to 6. [Item 8] The expandable member includes a porous body including a plurality of fibers. The medical device according to any one of items 1 to 7. [Item 9] The expandable member has a larger diameter in the expanded state than in the compressed state, and the medical device according to any one of items 1 to 8. [Item 10] The side opening is one of a plurality of side openings extending into the shaft, and the medical device according to any one of items 1 to 9. [Item 11] The expandable member is fixed to the shaft along the entire length of the expandable member, and the medical device according to any one of items 1 to 10. 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 the disclosure. The disclosed apparatus may include various suitable computer systems and / or computing units incorporating a plurality of hardware components, such as, for example, a processor and a non-transitory computer-readable medium, that enable the apparatus to perform one or more operations during a procedure according to that described herein. Other aspects of the disclosure will be apparent to those skilled in the art from consideration of the specification and the manner of the features disclosed herein. The specification and examples are intended to be considered as merely illustrative.

Claims

**Claim 1** A medical device, wherein the medical device comprises a longitudinal body extending from a proximal end to a distal end, and the longitudinal body has a lumen extending from the proximal end to the distal end, and one or more openings disposed at a distal portion of the longitudinal body and communicating with the lumen and the medical device comprises an expandable member disposed around a distal portion of the longitudinal body, the expandable member communicating with the lumen via the one or more openings, the medical device comprises a thread, a distal portion of the thread extending around the expandable member, and the thread being relatively movable with respect to the expandable member so as to move the expandable member from a contracted state to an expanded state. A medical device. **Claim 2** The medical device according to claim 1, wherein a proximal portion of the thread extends through the lumen. **Claim 3** The medical device according to claim 1 or 2, wherein the longitudinal body comprises a slot, and the expandable member is disposed between the slot and the distal end of the longitudinal body. **Claim 4** The medical device according to claim 3, wherein the distal portion of the thread extends outside the lumen through the slot. **Claim 5** The medical device according to claim 3 or 4, wherein the slot comprises an inclined surface. **Claim 6** The medical device according to any one of claims 1 to 5, wherein the distal portion of the thread comprises a plurality of knots coupled to the expandable member. **Claim 7** The medical device according to claim 6, 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. **Claim 8** The medical device according to claim 6 or 7, wherein each of the plurality of knots is configured to transition from a constrained configuration to a relaxed configuration. **Claim 9** The medical device according to any one of claims 6 to 8, wherein each of the plurality of knots is a slip knot. **Claim 10** The medical device according to any one of claims 6 to 9, wherein the most distal knot of the plurality of knots is adjacent to the distal end of the thread. **Claim 11** The medical device according to any one of claims 1 to 10, 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. **Claim 12** The medical device according to any one of claims 1 to 11, wherein the expandable member comprises a porous body. **Claim 13** The medical device according to any one of claims 1 to 12, further comprising a hub disposed at the proximal end of the longitudinal body, the hub being configured to be coupled to a pressure source to create suction through the lumen.

14. The medical device according to any one of claims 1 to 13, wherein the distal end of the longitudinal body is closed.

15. The medical device according to claim 1, 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.

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