Medical systems, devices, and related methods for wound treatment

A medical device with a shape-shifting wire and porous body addresses the limitations of current EVAC devices by enabling prolonged wound drainage and easy removal, reducing replacement frequency and infection risk.

JP2026520011APending Publication Date: 2026-06-19BOSTON SCIENTIFIC SCIMED INC

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
BOSTON SCIENTIFIC SCIMED INC
Filing Date
2024-06-12
Publication Date
2026-06-19

AI Technical Summary

Technical Problem

Current endoscopic vacuum therapy (EVAC) devices for treating gastrointestinal tract wounds are inadequate, requiring frequent sponge replacements and posing risks of infection and discomfort due to nasal insertion, with no suitable devices available in the US market.

Method used

A medical device comprising a wire or tube with a porous body, configured to transition from a flat to a curved or helical shape, is used for endoscopic vacuum therapy, allowing prolonged wound drainage and reducing the need for frequent replacements by adapting to the shrinking wound cavity.

Benefits of technology

The device provides extended wound drainage with reduced frequency of replacements, minimizing patient discomfort and infection risk by maintaining contact with the wound cavity and facilitating easy removal as it shrinks.

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Abstract

The medical device includes a wire or tube and a porous body bonded to the distal portion of the wire or tube. The wire or tube is configured to transition from a first configuration to a second configuration. In the first configuration, the wire or tube is flat or linear. In the second configuration, the wire or tube is expanded into a curved or helical shape.
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Description

Technical Field

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

Background Art

[0002] Endoscopic surgeries and open surgeries of the gastrointestinal (GI) tract include, for example, colectomy, obesity surgery, esophagectomy, gastric bypass surgery, sleeve gastrectomy, etc. These surgeries can cause perforation of the GI tract, postoperative leakage, and other wounds. The morbidity and mortality rates of such wounds are quite high, and the treatment options for managing such wounds are limited. The options include surgical reoperation and endoscopic placement of a stent or one or more clips. Surgery is invasive and also increases the morbidity and mortality rates. Endoscopic stenting is a less invasive option. However, the placed stent can move from the intended position and / or can enclose an infection at the treatment site, which can worsen the infection and / or prevent drainage.

[0003] The systems, devices, and methods of the present disclosure can improve one or more of the above-mentioned deficiencies or address other aspects of the art.

Summary of the Invention

[0004] Each aspect disclosed herein can include one or more of the features described in relation to any of the other disclosed aspects. Aspects of the present disclosure relate, among other things, to systems, devices, and methods for treating a subject. This aspect relates to medical systems, devices, and methods for treating wounds, such as endoscopic vacuum therapy that includes applying negative air pressure to tissue for wound treatment.

[0005] In some embodiments, the medical device may include a wire or tube and a porous body coupled to the distal portion of the wire or tube. The wire or tube may be configured to transition from a first configuration to a second configuration. In the first configuration, the wire or tube is flat or linear. In the second configuration, the wire or tube may be expanded into a curved or helical shape.

[0006] The medical device may include one or more of the following embodiments: At least the distal portion of the wire or tube may include or be formed from a shape memory material. The wire or tube may be a vacuum tube configured to be coupled to a negative pressure source. The vacuum tube may be cylindrical with a central cavity extending along the longitudinal axis of the center of the vacuum tube. The vacuum tube may include a plurality of ports arranged along the length of the distal portion of the vacuum tube. The plurality of ports may be configured to apply negative pressure provided by the negative pressure source.

[0007] In the second configuration, the curved or helical shape of the wire or tube can be used to make the porous body helical. The porous body may be a sponge. The porous body may be cylindrical. The wire or tube may be configured to be deployed within a wound cavity, and the length of the wire vacuum tube within the wound cavity may be configured to decrease as the size of the wound cavity decreases.

[0008] The wire or tube may remain in the first configuration when exposed to a first temperature, and may transition to the second configuration when exposed to a second temperature. The second temperature may be body temperature. The porous material may cover only a portion of the distal end of the wire or tube. The porous material may cover the entire distal end of the wire or tube. The medical device may include a plurality of markers arranged along the length of a portion of the wire or tube. The plurality of markers may be radiopaque.

[0009] In one or more other embodiments, the medical device may include a vacuum tube configured to be inserted into the working channel of an endoscope. The vacuum tube may be configured to be coupled to a negative pressure source. The medical device may also include a porous body coupled to the distal portion of the vacuum tube. The vacuum tube may be configured to transition from a first configuration to a second configuration. In the first configuration, the vacuum tube may be flat or linear. In the second configuration, the vacuum tube is expanded, and the distal portion of the vacuum tube and the porous body may have a helical shape.

[0010] The medical device may include one or more of the following embodiments: The vacuum tube remains in the first configuration when exposed to a first temperature and can transition to the second configuration when exposed to a second temperature. The medical device may also include a plurality of markers arranged along the length of the vacuum tube. The plurality of markers may be radiopaque and / or color-coded.

[0011] In one or more additional embodiments, the medical device may include a wire or tube. At least the distal portion of the wire or tube may include or be formed from a shape memory material. The wire or tube may include a plurality of radiopaque markers. A porous body may be bonded to the distal portion of the wire or tube. The wire or tube may be configured to transition from a first configuration to a second configuration. In the first configuration, the wire or tube may be in a flat or linear configuration. In the second configuration, the wire or tube may be expanded into a curved or helical shape.

[0012] The medical device may include one or more of the following embodiments: The wire or tube may be a vacuum tube configured to be coupled to a negative pressure source. The vacuum tube may include a central cavity extending along the longitudinal axis of the center of the vacuum tube. The vacuum tube may include a plurality of ports arranged along the length of the distal portion of the vacuum tube. The plurality of ports may be configured to apply the negative pressure provided by the negative pressure source.

[0013] It will be understood that both the general description above and the detailed description below are for illustrative and explanatory purposes only and do not limit the invention as described in the claims. The terms “includes,” “contains,” or other variations thereof as used herein are intended to be non-exclusive. That is, a process, method, article, or apparatus that includes a list of elements does not include only those elements, but may include other elements that are not expressly listed or that are specific to such process, method, article, or apparatus. The term “diameter” may refer to the width if the element is not circular. The term “top” refers to the direction or side of the device in the orientation of use, and the term “bottom” refers to the direction or side of the device opposite to “top” in the orientation of use. The term “distal” refers to the direction away from the user / towards the treatment site, and the term “proximal” refers to the direction towards the user. Drawings may include arrows marked “P” and “D,” indicating the proximal and distal directions, respectively. The term “exemplary” is used to mean “example,” not “ideal.” The term "approximately," or similar terms (e.g., "substantially"), includes values ​​within + / - 10% of the stated value. [Brief explanation of the drawing]

[0014] The accompanying drawings incorporated herein and forming part thereof illustrate aspects of this disclosure and, together with the specification, help to illustrate the principles of this disclosure. [Figure 1] The following are perspective views of exemplary medical systems according to several embodiments. [Figure 2] The following are side views of the distal portion of an exemplary medical device according to several embodiments. [Figure 3] Exemplary medical device perspective views in several embodiments are shown. [Figure 4A] Exemplary medical device perspective views in several embodiments are shown. [Figure 4B] Figure 4A is a magnified side view of a part of the medical device. [Modes for carrying out the invention]

[0015] Detailed explanation Endoluminal vacuum therapy (EVAC) is a modified form of negative pressure wound therapy (i.e., vacuum therapy or wound vac) that can be used as an external treatment for chronic, non-healing wounds. This therapy involves inserting a vacuum-sealed sponge into the wound and applying negative pressure to the sponge to promote drainage. In a typical EVAC procedure, negative pressure is applied to the wound site from the inside within a GI tube, for example, through a nasogastric tube with a sponge at the end. The sponge is positioned in the perforation, leakage, or other wound using an endoscope, and then negative pressure is applied to promote drainage from the wound.

[0016] Currently, there are no EVAC devices or kits adapted for use in the United States. As a result, surgeons typically create their own devices by attaching sponges taken from trauma suction kits to nasogastric tubes. While these devices may be effective for draining fluid from wounds within the GI, they may require regular sponge replacement (approximately every 2-3 days) throughout the healing process, as the sponge size decreases as the wound heals and shrinks. In some cases, the sponge may need to be replaced up to 70 times. This continuous replacement of the sponge can cause discomfort to the patient, as the nasogastric tube is inserted and removed through the nasal cavity. Furthermore, there is a possibility of increased risk of infection with each sponge replacement, for example.

[0017] Accordingly, embodiments of the present disclosure include, in particular, devices, systems, and methods for EVAC procedures. In some embodiments, EVAC may include the endoscopic placement of a porous material (e.g., a sponge or other similar material) to a wound site such as a perforation, cyst, leakage, or anastomosis.

[0018] The porous material can be placed in the wound via a catheter, scope (such as an endoscope, bronchoscope, or colonoscope), tube, or sheath that can be inserted into the GI tube through a natural opening. The opening may be, for example, the nose, mouth, or anus, and the distal end of the catheter, scope, tube, or sheath (and therefore the porous material) can be placed in any part of the GI tube, including the esophagus, stomach, duodenum, large intestine, and small intestine.

[0019] Figure 1 shows an exemplary medical system 100. The medical system 100 may include an insertion device or endoscope 110 that can be inserted into the patient's esophagus 10. The endoscope 110 may include an umbilicus (not shown) which can connect the proximal portion of the endoscope 110 to a power source such as air, water, suction, or electricity, as well as to image processing and / or image display equipment. In some embodiments, the endoscope 110 may further include at least one image sensor 115 and at least one illumination element 118 located at the distal end 114 of the endoscope 110. The image sensor 115 and illumination element 118 help to precisely position the endoscope 110 near the wound during EVAC procedures. For example, the user can use the image sensor 115 and illumination element 118 to help position the distal end 114 of the endoscope 110 adjacent to a wound cavity 12, such as an anastomosis cavity. Next, the user can deploy the medical device 120 into the wound cavity 12 or deliver it by other means (for example, via a part of an endoscope 110). As described in detail below, the medical device 120 includes a porous body 122 coupled to at least one wire 124 for treating the wound cavity 12.

[0020] In some embodiments, a medical device 120 may be inserted into a working channel of an endoscope 110. The working channel terminates at a working channel opening 116. The distal end 114 of the endoscope 110 may include an elevator 112, which may be positioned within the distal portion of the working channel, for example, adjacent to the working channel opening 116. The elevator 112 is movable between at least two configurations and may be configured to change the orientation of the medical device 120 when a portion of the medical device 120 is positioned adjacent to the elevator 112 and / or distal to the elevator 112. The elevator 112 may also be referred to as a swing stand, pivot stand, lifting base, or other appropriate terminology. In some embodiments, the elevator 112 may be rotatably movable via an actuation wire or other control element coupled to and / or extending through the endoscope 110, for example. In some embodiments, although not shown, the endoscope 110 may include a handle with one or more actuators for, for example, moving the elevator 112, driving one or more image sensors 115 and illumination elements 118, controlling the deflection, position, or direction of the distal end 114, and / or controlling one or more facets of the distal end 114 and its components.

[0021] Note that in Figure 1, the distal end 114 of the endoscope 110 is shown in a “lateral” orientation. In the lateral configuration, the image sensor 115, the working channel opening 116, and the illumination element 118 may be positioned radially outward of the distal end 114, substantially perpendicular to the longitudinal axis of the distal end 114 of the endoscope 110. In other embodiments, the distal end 114 of the endoscope may be “forward” orientation. In other words, the features of the distal end 114 (e.g., the image sensor 115, the working channel opening 116, and the illumination element 118) may be oriented distally (i.e., forward of the most distal surface 111 of the distal end 114). This disclosure also encompasses other configurations in which the distal end 114 is “forward” orientation. The endoscope 110 may further include several lateral configurations and other forward configurations.

[0022] The insertion device or endoscope 110 has been described above as an endoscope, but the present disclosure is not limited thereto. Although the present disclosure refers to an endoscope in various places, unless otherwise specified, a duodenoscope, an endoscope, a gastroscope, an endoscopic ultrasound (EUS) scope, a colonoscope, a ureteroscope, a bronchoscope, a laparoscope, a cytoscope, a suction scope, a sheath, a catheter, or other suitable delivery device or insertion device can be used in combination with the systems, devices, elements, assemblies, methods, etc. described herein.

[0023] Continuing to refer to FIG. 1, as described above, the medical device 120 can include a porous body 122 coupled to a wire 124. The medical device 120 can also include one or more tubes, such as an outer tube 126. The wire 124 and the porous body 122 can be movable relative to one or more tubes, such as the outer tube 126. As will be described in detail below, by extending the wire 124 and the porous body 122 from the outer tube 126, it becomes possible to transition one or more of the wire 124 and / or the porous body 122 from a first configuration to a second configuration. Further, in some embodiments, the proximal portion of the outer tube 126 can be coupled to a suction source such that a negative pressure is applied to the wound cavity 12 through the outer tube 126. In some embodiments, the fluid in the wound cavity 12 may flow along the wire 124 and / or the porous body 122, for example, by capillary action, regardless of whether a negative pressure is applied through the outer tube 126.

[0024] The porous body 122 is, for example, cylindrical or ring-shaped and has a substantially circular opening at the center of the porous body 122. The porous body 122 may be coupled to the wire 124 by being wrapped around a portion (e.g., the distal portion) of the wire 124. In some embodiments, the porous body 122 may be a sponge or at least partially absorbent. In some embodiments, the porous body 122 may comprise any suitable biocompatible material that absorbs liquids and / or allows liquids to pass therethrough, e.g., by negative pressure. The materials may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The material of the porous body may be an open-cell foam. Suitable materials include polyurethane, polymers having ester and / or ether functional groups, composite materials, and other medical-grade materials.

[0025] In some embodiments, the wire 124 may be substantially cylindrical, e.g., solid or include one or more hollow openings at the center of the wire 124. The wire 124 may be formed from a shape memory material such as, for example, nitinol. Alternatively, the wire 124 may be formed from a polymeric material. In some embodiments, the wire 124 may be a tube such as, for example, a nasogastric tube. The wire 124 may be configured to be heat set to a particular configuration before being inserted into the working channel. For example, the wire 124 may be configured to maintain a first configuration (e.g., a straight and / or flat configuration) at a first temperature and transition to a second configuration (e.g., an expanded configuration) when reaching a second temperature (e.g., body temperature). Alternatively or in addition, as described below, the wire 124 is in the first configuration when surrounded or coated by an outer tube, and the wire 124 may transition from the first configuration to the second configuration when not surrounded, not coated, or extending from the outer tube.

[0026] As shown in Figure 1, at least the distal portion 124A of the wire 124 may have a curved or helical structure, for example in a second (e.g., extended) configuration. In some embodiments, the porous body 122 may be bonded to the wire 124 so that the distal portion 122A of the porous body 122 can mimic the helical structure of the distal portion 124A of the wire 124. Furthermore, the porous body 122 may be bonded to the wire 124 so that the porous body 122 moves together with the wire 124 between each configuration.

[0027] Figure 2 is a side view of the distal portion of the medical device 120 in a second or extended configuration. As shown, the porous body 122 is coupled to or surrounds the wire 124. In the second or extended configuration, the wire 124 and the porous body 122 may form three loops 130A, 130B, and 130C as shown. Alternatively, the wire 124 and the porous body 122 may form fewer or more loops. Furthermore, the wire 124 may be movable relative to one or more tubes (e.g., extendable distally, retractable proximally). As described above, the wire 124, and therefore the porous body 122, may be movable relative to the outer tube 126. Furthermore, the proximal portion of the wire 124 may be coupled to a sheath or an inner tube 128. In some embodiments, the inner tube 128 may be movable relative to the outer tube 126, for example, to control the position of the wire 124, i.e., the configuration of the wire 124 and the porous body 122. Furthermore, in some embodiments, the wire 124 and / or inner tube 128 can be made detachable or fragile, for example, so that the wire 124 (including the porous body 122) is delivered (e.g., deployed into the wound cavity 12). The wire 124 is then left in the wound cavity 12, and the rest of the medical device 120 and endoscope 110 are removed from the patient (e.g., from the esophagus 10).

[0028] In the second configuration, the curved or helical structure of the distal portion 124A of the wire 124 and the distal portion 122A of the porous body 122 may offer several advantages. For example, the curved or helical structure helps increase the surface area of ​​the porous body 122 within the wound cavity 12, thereby allowing the porous body 122 to collect (e.g., absorb) more fluid from the wound cavity 12 than a typical cylindrical sponge. Furthermore, the increased surface area and improved absorbency may allow the medical device 120 (e.g., including the porous body 122) to be retained in the wound cavity 12 for a longer period (i.e., reducing the frequency of removal and / or replacement).

[0029] Furthermore, the curved or helical structure of the porous body 122 and the wire 124 may help to facilitate contact between the porous body 122 and the inner wall 14 of the wound cavity 12. As a result, as the size of the wound cavity 12 shrinks throughout the healing process, the inner wall 14 may come into contact with and / or be pressed against the porous body 122. This allows the distal portion of the medical device 120 to be pushed or biased to exit the wound cavity 12 (for example, proximal). For example, at least a portion of the wire 124 may be flexible, so that, for example, a force acting on the wire 124 (for example, a predetermined radial force) causes the wire 124 to contract or otherwise shrink in size, as a result, the proximal end of the wire 124 can return (i.e., move proximal) or otherwise begin to exit the wound cavity 12 and / or esophagus 10. In some embodiments, a physician or other user can instead manually remove a portion of the medical device 120 from the wound cavity 12 by pulling the proximal end of the wire 124 and / or the inner shaft or inner tube 128 (Figure 2) when the size of the wound cavity 12 shrinks. The curved or helical shape of the porous body 122 and the wire 124 may also help to stretch or straighten the medical device 120 when it is gradually removed by the user, for example, within the outer tube 126. The changes in size and / or configuration allow for a reduction in the size of the medical device 120 simultaneously with the size of the wound cavity 12, eliminating the need to reposition or remove the medical device 120 and replace it with a smaller medical device 120 (e.g., a smaller porous body 122 and wire 124) when the size of the wound cavity 12 shrinks.

[0030] In some examples, when the porous body 122 is positioned on the distal portion 124A of the wire 124, the entire outer surface of the distal portion 124A of the wire 124 may be covered or surrounded by the porous body 122. In other examples, the porous body 122 may cover only one or more portions of the wire 124 (e.g., the distal portion 124A of the wire 124). For example, the porous body 122 may consist of multiple pieces, or it may have a shape and configuration such that some areas of the wire 124 remain exposed. In some of these embodiments, as shown in Figure 2, the porous body 122 may extend distally to the most distal end of the distal portion 124A of the wire 124, for example, to help form a soft, non-sharp, or other non-traumatic distal end of a medical device 120.

[0031] Figure 3 shows another medical device 320 which includes a porous body 322 arranged radially around a tube, such as a vacuum tube 304. In some embodiments, the vacuum tube 304 may be formed from a nasogastric tube. In some embodiments, the vacuum tube 304 may be cylindrical with a central lumen extending along the longitudinal axis of the center of the vacuum tube 304. The vacuum tube 304 may be flexible and have a length and / or width configured to extend through a working channel of an endoscope or other medical device. The vacuum tube 304 may be coupled to and communicate with a vacuum or negative pressure source (not shown) at its proximal portion 304B. The vacuum source may supply negative pressure to the vacuum tube 304.

[0032] As shown in Figure 3, the vacuum tube 304 may include a plurality of suction ports 306 along its length, for example, along the distal portion of the vacuum tube 304. The suction ports 306 may be evenly or unevenly spaced along a portion of the vacuum tube 304 (e.g., the distal portion 304A). The suction ports 306 may help maintain negative pressure within the wound cavity 12. For example, the suction ports 306 may help apply negative pressure to the wound cavity 12 supplied by a suction source or negative pressure source (e.g., a vacuum source) coupled to, for example, the handle of the medical device 320. By applying negative pressure, the suction ports 306 can draw fluid through the porous body 322, for example, through the distal portion 322A of the porous body 322. Thus, the suction ports 306 may help maintain fluid drainage even as the size of the wound cavity 12 shrinks throughout the healing process. In some embodiments, one or more of the suction ports 306 may also be used to deliver a fluid (e.g., saline solution, antibiotic solution, etc.) to the wound cavity 12, for example, to assist in cleaning the wound cavity 12 and / or to treat the wound cavity 12 in other ways.

[0033] In some embodiments, the vacuum tube 304 may be formed from a polymer or other suitable biocompatible material. Alternatively or in addition thereto, in some embodiments, the vacuum tube 304 may include a shape memory membrane, such as a nitinol membrane, or the vacuum tube 304 may be formed from a shape memory and / or thermosetting material (e.g., nitinol). In these embodiments, the vacuum tube 304 may be inserted into the working channel (not shown) of an endoscope in a linear, flat, or flattened configuration before being deployed into a wound, e.g., a wound cavity 12, or otherwise positioned. A linear configuration of the vacuum tube 304 may be useful for inserting a medical device 320 into the working channel of an endoscope, e.g., the working channel of an endoscope 110 (Figure 1). After being deployed into or positioned in the wound cavity 12 (e.g., after being extended distal to the working channel opening), the vacuum tube 304 can be transitioned to an expanded configuration. In some embodiments, the extended configuration of the vacuum tube 304 may include a distal portion of the vacuum tube 304 that forms a curved or helical configuration. Furthermore, in some embodiments, one or more of the porous body 322 or the vacuum tube 304 may be provided with anticorrosive properties to prevent or suppress infection and / or extend the period in which the porous body 322 can remain in the wound cavity 12.

[0034] Furthermore, any medical device described herein may include one or more markers to allow the user to visually identify the medical device when it is deployed inside the body. For example, as shown in Figures 4A and 4B, the medical device 420 (e.g., as part of a medical system 400) may include a number of markers 406A-D along a vacuum tube (not shown) or wire 424, for example, along a portion of the vacuum tube or wire 424 that may be adjacent to or near the esophagus 10 when the medical device 420 is placed in the wound cavity 12. At least a portion of the wire 424 may include a porous body 404 as described above. At least the distal portion 424A of the wire 424 may have a curved helical shape similar to that described above, and may also include a shape memory material. The shape memory material allows the wire 424 to be in a linear configuration (Figure 4B) while it is inserted into the working channel of the endoscope 110 (Figure 1), and then to transition to an expanded, curved, or helical configuration (Figure 4A) when it is unfolded into the wound cavity 12 or extended distally to the working channel opening 116 of the endoscope 110. In some embodiments, markers 406A-406D may be spaced apart along one or more portions of the helical portion of the wire 424. Furthermore, while Figures 4A and 4B show a medical device 420 including the wire 424, it should be noted that in some embodiments, the medical device 420 may include a vacuum tube containing one or more markers 406A-D as described above.

[0035] As described above, during the healing process, as the size of the wound cavity 12 decreases (for example, as the wound cavity 12 heals), the distal portion 424A of the wire 424 may be compressed. As the size of the wound cavity 12 decreases, the wire 424 may be pushed or otherwise biased out of the wound cavity 12, for example, the proximal portion of the wire 424 may be pushed into the esophagus 10. Alternatively, a physician or other user may manually remove a portion of the medical device 420 (e.g., the wire 424) from the wound cavity 12 by manually pulling the nearest end 424B of the wire 424 (or the tube attached to the wire 424). In either case, it may be helpful for a physician or other user to be able to visualize how much of the wire 424 remains in the wound cavity 12 and / or how much of the wire 424 has moved into the esophagus 10. Therefore, in some embodiments, markers 406A-D are included on the wire 424 and can be easily visualized using one or more fluoroscopic or imaging techniques. For example, in some embodiments, markers 406A-D may be color-coded and / or radiopaque. Thus, a physician or other user can determine the length of the medical device 420 remaining in the wound cavity 12 at any point in the healing process using fluoroscopy or one or more other imaging techniques. As a result, the user can easily determine whether a smaller or larger portion of the medical device 420 needs to be removed from the wound cavity 12 and monitor the healing process.

[0036] Furthermore, in some embodiments, markers 406A-D may help eliminate the need for a physician or other user to determine the size of the wound cavity 12 before deploying or otherwise positioning the medical device 420 within the wound cavity 12. For example, markers 406A-D may be coded (e.g., color-coded) so that a user can visually identify specific codes or markers on the excess length of the medical device 420. For example, one or more of the markers 406A-D may have different colors, sizes, shapes, patterns, etc., so that a user can visually identify and distinguish between the markers 406A-D. This allows the user to visually identify the length or amount of the medical device 420 inside or outside the wound cavity 12. Once the excess length of the medical device 420 enters the esophageal lumen (e.g., esophagus 10), the user can visually identify one or more of the markers 406A-D to confirm that the appropriate length or portion of the medical device 420 is positioned within the wound cavity 12. Alternatively, or in addition to the above, markers 406A-D may help to confirm that the porous body 404 seals the wound cavity 12 from the esophageal lumen at least partially (e.g., completely).

[0037] The principles of this disclosure are described herein with reference to exemplary examples for specific uses, but it should be understood that this disclosure is not limited thereto. For example, this disclosure refers to EVAC as an exemplary procedure and to GI tubes as typical lumens for the systems and methods of this disclosure. However, the systems, devices and methods of this disclosure can be used for any appropriate medical procedure in any lumen or body cavity within the body, for example, to assist in the drainage of fluid from a wound at any location within the body. Those skilled in the art and with access to the teachings provided herein will recognize additional modifications, applications, and substitutions of equivalents within the scope of the examples described herein. Therefore, the present invention should not be considered limited by the foregoing description.

Claims

1. It is a medical device, Wire or tube and The wire or tube comprises a porous body attached to its distal portion, The wire or tube is configured to transition from a first configuration to a second configuration. In the first configuration described above, the wire or tube is flat or linear in shape. In the second configuration described above, the wire or tube is expanded into a curved or helical shape, a medical device.

2. The medical device according to claim 1, wherein at least the distal portion of the wire or tube includes or is formed from a shape memory material.

3. The medical device according to claim 1 or 2, wherein the wire or tube is a vacuum tube configured to be connected to a negative pressure source.

4. The medical device according to claim 3, wherein the vacuum tube is cylindrical and has a central cavity extending along the longitudinal axis of the center of the vacuum tube.

5. The medical device according to claim 4, wherein the vacuum tube includes a plurality of ports arranged along the length of the distal portion of the vacuum tube, and the plurality of ports are configured to apply negative pressure provided by the negative pressure source.

6. The medical device according to any one of claims 1 to 5, wherein the curved or helical shape of the wire or tube causes the porous body to be helical.

7. The medical device according to any one of claims 1 to 6, wherein the porous body is a sponge.

8. The medical device according to any one of claims 1 to 7, wherein the porous body is cylindrical.

9. The medical device according to any one of claims 1 to 8, wherein the wire or tube is configured to be deployed within a wound cavity, and the length of the wire vacuum tube within the wound cavity is configured to decrease as the size of the wound cavity decreases.

10. The medical device according to any one of claims 1 to 9, wherein the wire or tube remains in the first configuration when exposed to a first temperature and transitions to the second configuration when exposed to a second temperature.

11. The medical device according to claim 10, wherein the second temperature is body temperature.

12. The medical device according to any one of claims 1 to 11, wherein the porous body covers only a portion of the distal end of the wire or tube.

13. The medical device according to any one of claims 1 to 11, wherein the porous body covers the entire distal end of the wire or tube.

14. The medical device according to any one of claims 1 to 13, further comprising a plurality of markers arranged along a portion of the length of the wire or tube.

15. The medical device according to claim 14, wherein the plurality of markers are radiopaque.